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Feasibility, acceptability and outcomes
at a 12-month follow-up of a novel
community-based intervention to
prevent type 2 diabetes in adults at high
risk: mixed methods pilot study
Linda Penn,
1,2
Vicky Ryan,
1
Martin White
1,2
To cite: Penn L, Ryan V,
White M. Feasibility,
acceptability and outcomes at
a 12-month follow-up of a
novel community-based
intervention to prevent type 2
diabetes in adults at high
risk: mixed methods pilot
study. BMJ Open 2013;3:
e003585. doi:10.1136/
bmjopen-2013-003585
▸Prepublication history for
this paper is available online.
To view these files please
visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2013-003585).
Received 11 July 2013
Revised 23 September 2013
Accepted 9 October 2013
1
Institute of Health and
Society, Newcastle University,
Newcastle upon Tyne, UK
2
Fuse, UKCRC Centre for
Translational Research in
Public Health
Correspondence to
Linda Penn;
linda.penn@ncl.ac.uk
ABSTRACT
Objectives and design: Lifestyle interventions can
prevent type 2 diabetes (T2D) in adults with impaired
glucose tolerance. In a mixed methods pilot study, we
aimed to assess the feasibility, acceptability and
outcomes at a 12-month follow-up of a behavioural
intervention for adults at risk of T2D.
Participants: Adults aged 45–65 years with a Finnish
Diabetes Risk Score (FINDRISC) ≥11.
Setting: The intervention was delivered in leisure and
community settings in a local authority that ranks in
the 10 most socioeconomically deprived in England.
Intervention: A 10-week supported programme to
promote increased physical activity (PA), healthy eating
and weight loss was delivered by fitness trainers as
twice-weekly group PA or cookery sessions, each
followed by behavioural counselling with support to
12 months.
Outcome measures: We assessed feasibility and
acceptability of the intervention, and change in
behavioural and health-related outcomes at 6 and
12 months.
Results: From 367 registers of interest, 218 participants
were recruited to the programme with baseline mean
(SD): age 53.6 (6) years, FINDRISC 13.9 (3.1), body
mass index 33.5 (5.9) kg/m
2
, waist circumference 108.1
(13.7) cm, PA levels (self-report): daily total 49.1 (5.9)
metabolic-equivalent (MET) h/day. Follow-up at
12 months was completed by 134 (61%) participants,
with an estimated mean (95% CI) change from baseline
in weight −5.7 (−7.8 to −2.8); −2.8 (−3.8 to −1.9) kg,
waist circumference −7.2 (−9.2 to −5.2); −6.0 (−7.1 to
−5.0) cm, and PA level 7.9 (5.8 to 10.1); 6.7 (5.2 to 8.2)
MET h/day equivalent, for men and women, respectively
(from covariance pattern mixed models). Participants
reported an enjoyable, sociable and supportive
intervention experience.
Conclusions: Participants’views indicated a high level
of intervention acceptability. High retention and positive
outcomes at 12 months provide encouraging indications
of the feasibility and potential effectiveness of the
intervention. A definitive trial of this intervention is
warranted.
INTRODUCTION
Type 2 diabetes (T2D) is an increasingly
prevalent chronic disease that is progressive,
debilitating and costly to treat.
1
There is
strong evidence from efficacy trials that onset
of T2D can be delayed or prevented by life-
style interventions in adults with impaired
glucose tolerance (IGT),
23
but translating
such interventions to effective, routine deliv-
ery remains challenging. Early translational
diabetes prevention studies conducted in
Finland, Germany and the US assessed
weight loss as an intermediate health
outcome, thus assuming that weight loss,
achieved through these interventions deliv-
ered to high-risk individuals, would predict
reduced T2D incidence.
4
More recently, a
translational trial delivered to adults at high
Strengths and limitations of this study
▪Social marketing and modelling strategies were
used to design an engaging intervention.
▪The recruitment campaign was successful in
reaching the target population, but was time
consuming.
▪Positioning the intervention in leisure services
helped to avoid ‘medicalising’type 2 diabetes
risk and facilitated the provision of a variety of
physical activities with opportunities for mainten-
ance of these postprogramme. This mode of
delivery is scalable, but assessment of cost-
effectiveness is necessary.
▪The group-based physical activity and cookery
sessions encouraged social support, engage-
ment and positive reinforcement regarding
behaviour change.
▪More women than men were recruited, although
retention in the programme was slightly greater
for men than women.
▪We identified a need to adapt the programme to
attract people from ethnic minority communities.
Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585 1
Open Access Research
risk in a primary care setting, with a 4.2-year median
follow-up and T2D incidence as the primary outcome,
demonstrated 36.5% relative risk reduction (p < 0.005)
in T2D incidence in the lifestyle intervention group
compared to a usual care control group.
5
This risk
reduction is less than the 57% risk reduction achieved
in some efficacy trials.
6
The authors of this primary care
trial acknowledge the difficulties in translating evidence
for effective implementation and suggest that “the feasi-
bility and effectiveness of lifestyle interventions need to
be validated within the population in which they are
intended to be used.”
5
The UK National Institute for Health and Care
Excellence (NICE) guidance for preventing T2D in
high-risk individuals identified evidence gaps relating to
risk identification of those suitable for lifestyle-change
programmes and the need for translation of research
evidence to UK practice.
3
A report commissioned by
NICE highlighted the increased prevalence of T2D in
low socioeconomic status groups and acknowledged that
engaging people from these groups in preventive inter-
ventions is challenging.
7
Translational T2D prevention studies have generally
used classroom-based behavioural counselling
48
and this
approach is advocated in the development and implemen-
tation of a European Guideline and Training Standard for
Diabetes Prevention (IMAGE) guidelines.
910
Similarly, the
Good Ageing in Lahti region (GOAL) before-and-after
implementation study for T2D prevention used a struc-
tured counselling programme that drew on social cogni-
tive and self-regulation theories of behaviour change.
11
However, the Finnish Diabetes Prevention Study (DPS)
12
and American Diabetes Prevention Programme (DPP)
13
trials (which provided efficacy evidence for T2D preven-
tion) both included group delivered physical activity (PA)
sessions. Experiential learning theory emphasises the
central role that a ‘here-and-now’concrete experience,
along with observation and reflection, plays in promoting
subsequent higher order purposeful action.
14
In this
experiential approach, performing an action in a specific
instance and considering its effects is precedent to gener-
alisation.
15
We therefore developed an alternative
approach to intervention delivery that included group
delivered PA sessions to provide immediate experience of
different exercise activities, facilitate peer interaction and
accommodate different learning styles.
16
We have drawn
on experiential learning theory as well as behaviour
change theories and techniques in intervention develop-
ment.
17–19
We report on the feasibility, acceptability and behav-
ioural and health-related outcomes at a 12 month
follow-up of a novel community-based intervention
called ‘New life, New you’(NLNY), directed at adults at
risk of T2D. NLNY was novel in its delivery via supported
group PA and cookery sessions, each followed by reflec-
tion, advice and counselling.
20 21
In England, health improvement responsibilities are
assigned to local government (from April 2013). Thus,
NLNY, which was designed as a health and leisure
service partnership to be delivered by local authority
employed fitness trainers, offers a model with strong
potential for future public health commissioning and
service delivery. Feasibility and acceptability of this novel
intervention were assessed in preparation for a definitive
effectiveness trial.
METHODS
Objectives
We aimed to assess the feasibility, acceptability and likely
effectiveness of the intervention to change PA, weight and
other health-related outcomes at 12 months of follow-up.
Study design, participants and data collection
We used mixed methods to assess process and outcomes
at 6 and 12 months of follow-up,
22
using an uncontrolled
before-and-after study design, with embedded qualitative
interviews.
Two participant cohorts were recruited between March
2009 and November 2010, the first supported by social
marketing campaigns and the second by word of mouth
or ‘signposted’from primary care. Inclusion criteria
were: age 45–65 years, living in central Middlesbrough
UK, and with elevated risk of T2D. Individualised 10 year
risk of T2D was determined at baseline using the Finnish
Diabetes Risk Score (FINDRISC), a prospective risk
assessment tool that uses simple, non-invasive measures,
including height, weight and waist circumference, as well
as questions about family history and lifestyle.
23
To give
an indication of socioeconomic status, we used home
post codes to assign the English Index of Multiple
Deprivation (IMD), an ecological, composite measure
based on routinely available data in seven categories of
deprivation (income, employment, health and disability,
education skills and training, barriers to housing and
other services, crime and living environment) at the
Lower Super Output Area (LSOA: a small administrative
area with a population of about 1500) level to each par-
ticipant.
24
Previous diagnoses of T2D or inability to par-
ticipate in moderate PA were exclusion criteria. Details of
the target population, and recruitment strategies have
been reported previously.
20 21
Participants completed the
standard local authority leisure services questionnaire,
which included questions regarding medication, diag-
nosed medical conditions and any other condition that
might prevent people from participating in PA. The
leisure services standard protocol for reporting injury or
other adverse side effects was used. Following a brief
screening (self-report of: age, area of domicile and
history of T2D), potential participants were invited to
attend an individual assessment that was conducted by
one of the NLNY health and fitness trainers in a conveni-
ent community location. The consultation incorporated
motivational interviewing techniques to promote engage-
ment in the intervention.
25
After their baseline assess-
ment, those with FINDRISC 11–20 who wished to
2Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585
Open Access
participate were allocated to the intervention pro-
gramme. Those with FINDRISC>20 were advised to see
their general practitioner (GP) and were able to join the
programme with their GP’s permission (providing there
was no diagnosis of T2D). The trainers conducted
further assessments at 6 and 12 months in one-to-one
consultations.
To assess intervention feasibility and acceptability, we
recorded recruitment and retention through the
programme and follow-up. We conducted qualitative
interviews with participants at 6 and 12 months of postpro-
gramme. The interview topic guide was developed from
our previous research in this area.
26
Interviewees were pur-
posively selected for success in PA increase at 6 or
12 months of follow-up. Interviews were recorded and
transcribed verbatim. As part of the qualitative evaluation,
we sought to elicit participants’views on acceptability of
the intervention and research procedures. Participant per-
spectives of their behaviour changes are reported
separately.
21
Outcome measurements
To evaluate likely effectiveness, the primary outcome
measures were change in PA levels and variety. These
were assessed through a self-report instrument that we
developed from the PA diary used in the Newcastle
arm of the European Diabetes Prevention Study
(EDIPS-Newcastle) randomised controlled trial.
27
We cal-
culated the daily total PA level in metabolic-equivalent
tasks for each hour (MET h) from a 24 h recall, recorded
in half-hour periods of activity level (eg, lying down=1,
standing=3, brisk walking=5, strenuous activities=8).
28
The amount and variety of leisure time PA over level 5
was recorded as a recall of type of activity and number of
sessions of each activity of at least 15 min duration over
the previous week. Secondary outcomes were change in
weight and waist measurements and FINDRISC.
23
Dietary
assessment was based on questions about specific foods
(number of portions of fruit and vegetables consumed
daily, and type of bread, milk and fat usually consumed),
and was aligned with the dietary advice given to partici-
pants. All measures were assessed at each time point.
Intervention development
Intervention design built on research evidence for T2D pre-
vention including the Finnish DPS
12
and EDIPS-
Newcastle.
26 27
The intervention was developed in accord-
ance with the UK National Social Marketing Centre bench-
mark criteria,
29
designed for adults living in
socioeconomically disadvantaged areas, and intended to be
delivered in leisure and community settings.
20 21
Market
segmentation identified target groups as middle-aged and
older men and women on low incomes.
30
Consultations
with stakeholders (potential participants and experienced
local fitness trainers) informed creative work with the deliv-
ery staff to develop the intervention design, name, logo and
project documents, all of which were refined in usability
testing.
31
Intervention
NLNY trainers delivered a 10-week programme of twice-
weekly 1.5 h sessions to groups of 15–20 participants.
Participant preferences, for example for a single-sex activ-
ity group or for particular PAs, were accommodated where
possible. Each NLNY session comprised a supervised PA
or, on two or three occasions within each 10-week pro-
gramme, a cookery session, followed by a reflective discus-
sion that covered PA, nutrition, weight management and
strategies for behaviour change. Monthly NLNY newslet-
ters with information, advice and recipes were available to
participants, mostly online. PAs centred on the interests of
each participant group, with flexibility to repeat popular
activities. Sessions were leisure centre based, but also
included trainer-led walks. The supported cookery sessions
were designed to encourage healthy eating and to demon-
strate the ease with which healthy food could be prepared.
Nutritional information incorporated the importance of
reading food labels with advice based on the Eat-well
plate,
32
including reduction in fat and increase in fibre
intake, in line with the DPS protocol and NICE guid-
ance.
312
Weight reduction was advised for those over-
weight, who were the majority. The trainers introduced
behaviour change strategies (including goal setting, action
planning, barrier identification, social support, self-
monitoring, advance planning for relapse prevention and
contingent rewards), as the need arose, with regular repe-
tition during the supported sessions.
18
At the end of the 10-week programme, participants who
had completed ≥80% attendance received an ‘access to
leisure’card that enabled free leisure service use for
12 months. After the programme, ongoing support with
regular mobile phone text message and email reminders,
‘drop-in’activity sessions and encouragement to join in
local events such as organised walks and runs continued
up to the assessment at 12 months of follow-up. The full
intervention manual is available from the corresponding
author.
Data analysis
We analysed outcome data using SPSS (IBM SPSS Inc,
V.17) and SAS/STAT, V.9.2 software.
33
For this feasibility
study, analyses of the data collected were mainly descrip-
tive. For repeated measures analysis of continuous
outcome variables, we used covariance pattern mixed
models which allow appropriate estimation of the mean
change (and associated SE) between visits, allowing for
missing observations over time.
34
We estimated (with
95% CIs) mean change from baseline to 6 and
12 months for PA level, weight, waist circumference and
FINDRISC data for those participants who started the
10-week programme. From the available self-report data,
we report the number and percentage of those who par-
ticipated in different activities in the previous week and
the number and percentage of different foods con-
sumed within food groups at each time point for those
who completed 12 months in the study.
Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585 3
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We analysed transcribed data, from the interview
study, using the framework approach.
35
A priori themes
explicit in the topic guide were extended with themes
emerging from the data. NVivo software was used to
arrange the data. Detailed qualitative analysis, based on
the theoretical domains framework, is reported separ-
ately.
19 36
For the analysis reported here, key themes
relating to acceptability were extracted along with illus-
trative quotes.
RESULTS
From 271 registers of interest for the first cohort 166
(61%), participants were recruited to the programme,
including 56 (26%) recruited via word of mouth. From
96 registers of interest for the second cohort, 52 (54%)
participants were recruited, including 44 (85%)
recruited via word of mouth. In total, there were 367
registers of interest and the trainers recruited 218 (59%)
participants to the programme. Just over half (53%) of
the NLNY participants lived in an LSOA within the
lowest quintile of deprivation based on 2010 IMD ranks
for all England. A total of 134 (61%) programme group
participants completed follow-up at 12 months. More
women than men were recruited, although this differ-
ence was less in the second cohort, and a slightly higher
proportion of men than women completed the
12-month follow-up. A flow chart of progress through
the NLNY programme to 12 months of follow-up is
detailed in figure 1.
Baseline data (continuous variables) for all those
recruited to the programme and for male and female
participants separately are shown in table 1 and distribu-
tions across key categories of these variables are shown
in table 2. A total of 194 (89%) participants were
recorded as overweight or obese, of which 64 (29%)
were severely obese (body mass index, BMI>35 kg/m
2
).
Of the men recruited, 61 (91%) recorded a waist cir-
cumference >91 cm; 126 (83%) of women recorded a
waist circumference >83 cm. Participants reported taking
part in PA at a level of >5 MET h/day for only 1 h/day
on average with one activity being the median number
of PA types. The trainers recruited 21 participants with
baseline FINDRISC<11, all of whom were overweight
and inactive, into the programme. The question, “Do
you smoke currently?”was answered by 125 (57%) parti-
cipants, of whom 3 men and 3 women reported cur-
rently smoking. The question, “Have you ever smoked?”
was answered by 140 (64%) participants, of whom 20
men and 44 women reported smoking at some time
previously.
Baseline values for key variables were mostly similar
for those who completed 12 months of follow-up and for
those who left the study early. However, participants who
dropped out of the programme by 10 weeks or left
before 6 or 12 months of follow-up came from signifi-
cantly more deprived areas than those who completed
these follow-up assessments, as shown in table 3.
Changes in key variables are shown in table 4. The
results suggest overall increases in PA levels (total and
leisure time), an increase in the variety of PA and
decreases in the BMI, weight, waist circumference and
FINDRISC. Changes were greater in the first 6 months
of follow-up than in the period from 7 to 12 months.
Nevertheless, beneficial changes in all outcomes
occurred between 0 and 12 months with estimated mean
(95% CI) change from baseline in weight −5.7 (−7.8 to
−2.8); −2.8 (−3.8 to −1.9) kg, waist circumference −7.2
(−9.2 to −5.2); −6.0 (−7.1 to −5.0) cm and PA level 7.9
(5.8 to 10.1); 6.7 (5.2 to 8.2) MET h/day equivalent for
men and women, respectively.
Table 5 shows the change in numbers (%) participat-
ing in specific leisure time activities at baseline, 6 and
12 months. Participation in gym-based activities, sports
and ‘other’activities (ie, any activities not otherwise spe-
cified, including the popular aqua-fit sessions) showed
substantial increases over time.
Table 6 shows changes in numbers (%) consuming
categories of specific foods at baseline, 6 and 12 months.
There were notable increases in consumption of brown
bread, soft margarine and five or more portions of fruit
and vegetables/day, and decreases in consumption of
white bread, butter and hard margarine.
Table 7 shows key themes and associated quotations
relating to acceptability of the intervention, derived
from the qualitative interviews. The intervention delivery
environment was viewed as welcoming, friendly, sociable,
enjoyable, comfortable and convenient. The only nega-
tive comment was about the potential for disruptive ele-
ments within groups, although this comment was
balanced by an appreciation of the trainers’efforts to
contain this. Participants had high praise for the trainers
and would recommend the programme to others.
DISCUSSION
Statement of principal findings
Most participants came from areas of social deprivation,
reflecting the target population, and fewer men than
women were recruited. High retention and further
recruitment by word-of-mouth recommendation, along
with positive comments in the qualitative interviews,
suggest high levels of acceptability of the intervention.
Positive outcomes at 12 months, including increased PA,
weight loss, reduction in waist circumference and
FINDRISC, and increase in the consumption of fruit
and vegetables, are encouraging indications of the likely
effectiveness of the intervention. Intervention delivery,
by fitness trainers in leisure and community settings
incorporating robust outcome data collection for moni-
toring purposes, provides a viable model for service pro-
vision in the UK.
Almost all NLNY participants were overweight or
obese at baseline, with elevated risk of developing T2D.
Just over half (53%) of the participants were living in
areas located in the lowest, and 65% in the lowest two,
4Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585
Open Access
quintiles of deprivation based on 2010 IMD ranks for all
England. Recruitment and retention of people from this
population in a preventive intervention is challenging
and the retention rate of 61% at 12 months, with many
participants recruited by word of mouth, demonstrates
intervention acceptability. Mean beneficial change was
demonstrated in measures of PA and in objective mea-
sures of weight and waist circumference, resulting in
Figure 1 Flow chart of recruitment and progress through the ‘New life, New You’pilot evaluation.
Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585 5
Open Access
reduction in FINDRISC for many participants. The main
areas of PA increase were gym-based and sports activities
(including badminton) as well as popular ‘aqua-fit’ses-
sions (which were provided separately for men and
women). Walking, hobbies and swimming activities were
fairly consistent across the study time period, which sug-
gests that the new activities were additions rather than
replacements.
The dietary assessment was limited by resources and a
perceived need to minimise respondent burden. Of
interest was the increase in reported portions of fruit
and vegetables consumed per day. There were only
modest beneficial changes in other food groups.
Refinement of dietary advice to promote wholemeal
(rather than brown) bread and skimmed (rather than
semiskimmed) milk should be considered.
Strengths and limitations of the study
Recruitment and retention
Intervention development was strengthened by drawing
on social marketing (profiling a target population, pretest-
ing intervention design through stakeholder consultations
and positioning in community settings) and modelling
(using behavioural and intermediate health outcomes)
strategies to ensure an appropriate, engaging and
pragmatic intervention.
31 37
The promotional campaign,
led by the fitness trainers, was time consuming and ‘sign-
posting’from the National Health Services (NHS) Health
Checks programme within primary care might be a more
efficient long-term option for recruitment.
38
However, we
cannot be sure whether this different recruitment strategy
would affect retention and outcomes.
More women than men were recruited, in common
with previous diabetes prevention studies,
12 13
and this
remains a concern, especially in view of the greater
prevalence of T2D in men.
39
Our social marketing
approach to intervention development led us to provide
single-sex PA classes. However, further gender-sensitive
strategies need to be developed to attract men to partici-
pate in T2D prevention interventions.
40
Themes from the interview study suggest a high
degree of acceptability. However, these interviews were
conducted with participants who remained in the study
and may not reflect the perspectives of those who
dropped out. Those who left the study early tended not
to respond to contacts. Participants were recruited from
the community and although the early recruitment strat-
egy involved advertising the programme, later partici-
pants were mainly recruited through word of mouth. We
suggest that as later recruits only became interested in
this opportunity through those already participating,
Table 2 Numbers (%) in each category of baseline variable for ‘New life, New You’participants
Variable Number (%) in categories
Missing
data
FINDRISC 7–11 12–14 15–20 >20
49 (23) 73 (34) 75 (34) 7 (3) 14 (6)
Age groups (years) <49 50–54 55–59 60–65
77 (35) 50 (23) 48 (22) 38 (17) 5 (2)
IMD rank (All England quintiles) 54321
4 (2) 19 (9) 43 (20) 25 (12) 116 (53) 11 (5)
BMI categories (kg/m
2
)18.5–25 25–29 30–34 35–39 ≥40
5 (2) 51 (23) 79 (36) 38 (17) 26 (12) 19 (9)
Waist IDEA* categories men (cm) <84 84–91 92–98 99–106 ≥107
0 0 3 (5) 19 (28) 39 (58) 6 (9)
Waist IDEA* categories women (cm) <76 76–83 84–91 92–101 ≥102
0 2 (1) 12 (8) 44 (29) 70 (46) 23 (15)
*International day for the evaluation of abdominal obesity.
1=most deprived; 5=least deprived; BMI, body mass index; FINDRISC, Finnish Diabetes Risk Score; IMD, Index of Multiple Deprivation.
Table 1 Mean (SD) for continuous baseline variables of ‘New life, New You’participants, n=218 (men=67, women=151)
Variable n All participants n Men n Women
FINDRISC 204 13.9 (3.1) 63 14.1 (3.4) 141 13.9 (2.9)
Age (years) 213 53.6 (6.0) 67 51.3 (5.2) 146 54.7 (6.1)
IMD score 207 40.0 (21.6) 66 45.5 (20.3) 141 37.4 (21.8)
BMI (kg/m
2
) 199 33.5 (5.9) 64 34.6 (6.0) 135 33.0 (5.8)
Weight (kg) 202 92.1 (19.8) 65 105.5 (20.6) 137 85.7 (15.9)
Waist (cm) 189 108.1 (13.7) 61 116.4 (14.8) 128 104.2 (10.9)
Physical activity: total (MET h/day) 193 49.1 (5.9) 61 48.4 (6.3) 132 49.5 (5.8)
BMI, body mass index; FINDRISC, Finnish Diabetes Risk Score; IMD, Index of Multiple Deprivation; MET, metabolic-equivalent.
6Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585
Open Access
they were not a population subfraction with prior inter-
est in supervised PA training.
We did not exclude ethnic minorities from taking part
in the programme, but as only two people from these
groups became involved we identified this as a design
limitation, considering the potentially raised prevalence
of T2D within the UK South Asian and African commu-
nities.
3
We are currently developing an adaptation of the
programme,
41
specifically to target local ethnic minority
communities, which also includes provision for younger
age participants from these groups in line with NICE
guidance.
3
This adaptation will be similarly assessed for
feasibility, acceptability and outcomes at 12 months.
Recruitment to this study relied on a self-reported
FINDRISC.
23
We agreed on some flexibility for inclusion
in this feasibility study because the FINDRISC algorithm
includes a heavily weighted family history question and
validity is compromised where data on family history are
unavailable. Family history in risk score assessment intro-
duces bias (eg, for people from single-parent families or
people with younger than average parents),
42
which
might have importance for this socioeconomically disad-
vantaged participant population. Seven of those
recruited to NLNY who did not report family history at
baseline did so at 6 months, and we know that some of
this difference was due to new T2D diagnoses in family
members. The participants with baseline FINDRISC<11
were all overweight and inactive.
23
However, this flexibil-
ity in recruitment introduces a design limitation and
highlights the difficulty that the trainers experienced in
‘turning away’people who were keen to participate in
the programme. This difficulty was an important finding
from the feasibility evaluation and an alternative strategy
will be needed for a definitive trial. A risk score and con-
firmatory blood test, as advised in NICE guidance,
would ensure more precise inclusion criteria. In this
context, point of care glycated haemoglobin (HbA1c)
may be convenient. HbA1C cut-points to identify high-
risk individuals are recommended in NICE guidance,
but these do not identify a population with IGT and the
appropriate HbA1c cut-points for the purpose of pre-
ventive interventions are untested.
3
Data administration
In this pilot study, we asked the fitness trainers to under-
take risk assessment and collect all data. This strategy
was designed to reflect the likely future practice, with
inbuilt potential for robust monitoring and quality assur-
ance measures for service provision. However, data col-
lection involved new procedures for the fitness trainers
and some baseline data were not recorded. We have sub-
sequently improved the data administration procedures.
However, in a definitive trial, trial data collection will
need to be independent of intervention delivery.
Respondent burden was a key consideration for this
participant group and the data collection procedures
were designed to minimise this. Nevertheless, the dietary
assessment method was weak. We have subsequently
used the Dietary Instrument for Nutrition Education
(DINE) questionnaire as advised by the National Obesity
Observatory for weight management interventions.
43
In
adefinitive trial, the need for a more robust, objective
measurement of PA and better dietary assessment will
need to be balanced against increased respondent
burden.
Intervention delivery and capacity
The intervention design was strengthened by the incorp-
oration of individual and group-based delivery. The
one-to-one risk assessment consultations provided oppor-
tunities to introduce topics that facilitated motivational
interviewing.
23
The group-based PA and cookery sessions
encouraged social support with mutual encouragement.
Group-based sessions are likely to reduce cost and
Table 3 Mean (SD) for key baseline variables by retention/attrition at each follow-up stage
Variable
Numbers
available for
variable at
baseline (from
n=218 recruited)
Completed at
10 weeks
(n=179)
Withdrew
at 10 weeks
(n=39)
Completed at
6 months
(n=168)
Withdrew
at 6 months
(n=50)
Completed at
12 months
(n=134)
Withdrew
at 12 months
(n=84)
FINDRISC 204 14.1 (3.2) 13.2 (2.3) 14.1 (3.2) 13.4 (2.4) 14.1 (3.5) 13.7 (2.4)
Age (years) 213 53.9 (6.1) 52.0 (5.7) 54.1 (6.0) 51.9 (6.5) 54.3 (6.1) 52.2 (5.9)
IMD score* 207 38.0 (21.3) 49.7 (20.5) 38.0 (21.3) 47.0 (22.0) 36.8 (21.3) 45.7 (21.0)
BMI (kg/m
2
) 199 33.7 (6.0) 32.1 (4.4) 33.7 (6.2) 33.3 (5.3) 33.6 (6.2) 33.3 (5.2)
Weight (kg) 202 92.5 (19.9) 88.7 (18.5) 92.5 (20.2) 90.0 (17.6) 92.0 (20.3) 92.4 (18.9)
Waist (cm) 189 108.3 (13.5) 106.4 (14.4) 108.2 (13.6) 108.0 (13.6) 108.1 (13.8) 108.3 (12.9)
PA: Total
(MET h/day)
193 49.1 (6.1) 49.2 (4.8) 48.9 (5.9) 50.2 (6.2) 49.2 (6.1) 48.9 (5.6)
PA: Leisure
(h/week)
179 1.1 (.08) 1.3 (0.7) 1.1 (0.8) 1.4 (0.9) 1.1 (0.8) 1.3 (0.9)
*Significant difference between mean IMD scores of those who completed/withdrew at 10 weeks p=0.003, 6 months p=0.011 and 12 months
p=0.005. No significant difference between groups for any other variables.
BMI, body mass index; FINDRISC, Finnish Diabetes Risk Score; IMD, Index of Multiple Deprivation; MET, metabolic-equivalent; PA, physical
activity.
Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585 7
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Table 4 Model estimates with 95% CIs for key variables at baseline with changes at 6 and 12 months of follow-up for men and women separately
Variable Men Women
Baseline
Mean change* baseline
to 6 months
Mean change*
6–12 months Baseline
Mean change* baseline
to 6 months
Mean change*
6–12 months
Physical activity:
total (MET h/day)
48.5 (46.9 to 50.0) 5.1 (3.4 to 6.8) 2.9 (1.0 to 4.8) 49.4 (48.4 to 50.5) 4.5 (3.3 to 5.7) 2.2 (0.9 to 3.5)
Physical activity:
leisure (h/week)
1.4 (1.1 to 1.6) 1.0 (0.7 to 1.3) 0.1 (−0.2 to 0.5) 1.0 (0.9 to 1.2) 0.7 (0.5 to 0.9) 0.3 (0.1 to 0.5)
BMI (kg/m
2
) 34.6 (33.2 to 36.1) −1.4 (−1.9 to −0.9) −0.5 (−1.0 to 0.03) 33.0 (32.0 to 34.0) −0.8 (−1.1 to −0.6) −0.2 (−0.5 to 0.03)
Weight (kg) 105.5 (100.6 to 110.5) −4.2 (−5.6 to −2.8) −1.5 (−3.1 to 0.1) 85.7 (83.0 to 88.4) −2.2 (−2.9 to −1.6) −0.6 (−1.3 to 0.1)
Waist (cm) 116.4 (112.6 to 120.1) −5.3 (−6.7 to −3.9) −1.9 (−3.4 to −0.4) 104.2 (102.3 to 106.2) −4.5 (−5.2 to −3.7) −1.6 (−2.4 to −0.8)
FINDRISC 14.1 (13.2 to 14.9) −1.8 (−2.6 to −1.1) −1.2 (−2.0 to −0.4) 13.9 (13.3 to 14.4) −1.5 (−2.1 to −1.0) −0.4 (−1.0 to 0.2)
*A negative change indicates a fall on average from baseline to 6/6–12 months.
BMI, body mass index; FINDRISC, Finnish Diabetes Risk Score; MET, metabolic-equivalent.
Table 5 Number (%) of participants engaging in each
leisure time physical activity (with level greater than 5
MET h equivalent) in the previous week*
Participation in activity
Baseline 6 months 12 months
Walking 116 (66) 117 (66) 111 (63)
Hobbies†63 (36) 30 (17) 48 (27)
Dancing 7 (4) 10 (6) 11 (6)
Gym based‡10 (6) 115 (65) 79 (45)
Swimming 13 (10) 32 (18) 23 (13)
Sport§ 21 (12) 22 (12)
Others** 23 (13) 85 (48) 74 (42)
*Participants who completed the follow-up at 12 months (n=134)
with data at all three time points n=110.
†Hobbies comprised: car maintenance, gardening and
do-it-yourself.
‡Gym based included: a variety of locally available leisure centre
classes and individual gym equipment use.
§Sport comprised: athletic track use and badminton court use.
**Others referred to any activity not otherwise specifically
allocated (including popular aqua-fit classes).
Table 6 Number (%) of participants eating specific
categories of food at baseline, 6 and 12 months of
follow-up*
Food category Baseline 6 months 12 months
Milk
Skimmed 16 (17) 23 (24) 21 (21)
Semi-skimmed 73 (76) 69 (70) 72 (74)
Full cream 3 (3) 1 (1) 1 (1)
None 4 (4) 5 (5) 4 (4)
Item missing 2 (2) ––
Bread
Wholemeal 39 (40) 43 (44) 39 (40)
Brown 22 (22) 30 (31) 42 (43)
White 29 (30) 16 (16 9 (9)
None 3 (3) 3 (3) 6 (6)
Item missing 5 (5) 6 (6) 6 (6)
Spread
Low fat/sterol 18 (18) 21 (21) 22 (22)
Soft margarine 30 (31) 35 (36) 36 (37)
Butter/hard
margarine
42 (43) 28 (29) 24 (25)
None 7 (7) 13 (13) 16 (16)
Item missing 1 (1) 1 (1) –
Fat (cooking)
Spray oil 20 (20) 21 (21) 16 (16)
Oil 63 (64) 67 (68) 69 (70)
Hard fat/lard 1 (1) 2 (2) 0(0)
None 13 (13) 7 (7) 12 (12)
Item missing 1 (1) 1 (1) 1 (1)
Portions/day of fruit and vegetables
≤2 23 (24) 5 (5) 3 (3)
3–4 40 (41) 37 (38) 44 (45)
≥5 29 (30) 56 (57) 51 (52)
Item missing 6 (6) ––
*Participants who completed the follow-up at 12 months (n=132),
with dietary data at all three time points (n=98).
8Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585
Open Access
potentially improve the cost-effectiveness of the interven-
tion.
44
Positioning the intervention within leisure ser-
vices helped to avoid ‘medicalising’the problem and
enabled a variety of PAs to be provided. The trainers
were accessible to the participants on a casual basis,
both during the 10-week programme and after its com-
pletion, as they were regularly present in the leisure
centres with other groups. The trainers encouraged par-
ticipants to make independent use of leisure centre facil-
ities and join mainstream activity classes. New
mainstream classes were introduced in response to the
requirements of NLNY participants, some of whom
invested in their own access to leisure service cards after
completing follow-up at 12 months. The local leisure
centre continued to provide a meeting point for partici-
pants post follow-up. The standard (Register of Exercise
Professionals) training programmes for fitness trainers
provided a good foundation for intervention delivery,
which we enhanced with extra training in motivational
interviewing and good clinical practice. Similar delivery
capacity would be available in other areas of the UK by
utilising staff trained to deliver fitness programmes, such
as within local authority leisure services.
Intervention cost
In this study, we focused on developing an engaging
intervention and sustainable administration procedures.
Group sessions were used to maximise efficiency.
Table 7 Acceptability of the New Life New You intervention: key themes from participant interviews and illustrative quotes
Welcoming I was absorbed in from walking through the door (Participant M, male, age 48)
I was shown round and I realised I wasn’t the only one [overweight]. [There is] a
cross-section of people who actually use a gym (Participant K, male, age 63)
We’re always chatting and welcoming, very welcoming (Participant B, female, age 45)
Friendly, sociable, enjoyable,
supportive
Everybody was really friendly (Participant F, male, age 50)
You’re looking for a kind of, not friendship but …people association (Participant I, female,
age 60)
You’re meeting different people the different sessions you go to (Participant A, female, age
59)
I do enjoy the group, so that was an incentive in itself (Participant C, female, age 58)
It was one of the best things I have ever done. I thoroughly enjoyed it (Participant G,
female, age 57)
It is mixing with the people who are actually applying to this as well (Participant H, female,
age 54)
She watches me because I am frightened of the water you see even though I go to Aqua
fit; I’m frightened of the water so she tends to stay with me (Participant G, female, age 57)
Comfortable, convenient It felt very comfortable to come (Participant F, male, age 50)
[Men are] a lot shyer than women to join such a group. Just men was a big thing, all
shapes and sizes joined (Participant E, male, age 50)
The leisure centre opens early, so I can go swimming before work (Participant C, female,
age 58)
Well-paced, varied activities You are under no pressure (Participant M, male, age 48)
The more familiar you get with it [gym routine] the more confident you get (Participant K,
male, age 63)
The first activity was a walk and I did find that hard, but [I thought] I need to find out what
else there is so I carried on. I am glad I did push on (Participant G, female, age 57)
One of the good things about it is the level of choice (Participant J, female, age 59)
Trainers (rapport) They gave you so much encouragement along the way. They are a fantastic team
(Participant I, female, age 60). The commitment that they give is unbelievable (Participant
E, male, age 50)
They listen to what I have to say (Participant D, female, age 53)
Also, they are quite innovative (Participant A, female, age 59)
I didn’t know any of them [trainers] before I came in and at the end of the first session it
was as though I had known them for quite a long time (Participant M, male, age 48)
If they see someone that’s taking the Mick, they’ll pull them to one side (Participant F,
male, age 50)
Recommendable I’ve been raving on about it ever since to everybody (Participant 0, female, age 47)
The way I would put it to somebody is, ‘Just come and it’s an enjoyable experience’
(Participant M, male, age 48)
I met a lady who was already doing it. She said, ‘I think it’s great: go for it’(Participant J,
female, age 59)
Recommend? [I would] absolutely, totally and utterly (Participant F, male, age 50)
Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585 9
Open Access
Funding provision was appropriate for a developmental
project and further cost savings are being explored in
refining the service model. Economic evaluation of the
NLNY service model will be undertaken as part of a
definitive trial.
Sample size
This feasibility study has provided data that will inform
sample size estimation for a definitive trial and show
how the NLNY intervention performs in comparison to
interventions used in previous trials: for example, in
NLNY, 21% of participants lost ≥5% of their body
weight at 12 months of follow-up; the equivalent value in
EDIPS was 38%.
6
A comparison of reductions in the
waist circumference will also be informative.
45 46
Strengths and weaknesses in relation to other studies
In planning the NLNY intervention, we were able to
draw on the experience of EDIPS-Newcastle as previ-
ously described.
27
The efficacy evidence for lifestyle, diet
and PA interventions to prevent T2D has been tested in
research settings.
3
Although it is difficult to compare
across studies with different participant gender distribu-
tions and baseline levels for the outcome variables of
interest, it appears that weight loss observed at
12 months in this pilot study (mean 5.7 kg men, 2.8 kg
women and 4.3 kg overall) was comparable to that
achieved in the Finnish DPS (mean 4.2 kg) and more
than in EDIPS-Newcastle (mean 2.3 kg). Similarly, it
appears that the reduction in waist circumference
(mean 7.2 cm men, 6 cm women and 6.6 cm overall)
was more than in the Finnish DPS (mean 4.4 cm) and
EDIPS-Newcastle (mean 1.7 cm).
12 27
In the
International Day for the Evaluation of Abdominal
Obesity (IDEA) study, waist circumference was shown to
be a better predictor than BMI of diabetes and cardio-
vascular disease.
46
Some countries have already implemented large-scale
diabetes prevention programmes for high-risk groups.
Finnish national diabetes prevention program
(FIN-D2D) and GOAL were both conducted in
Finland,
47–49
and a state-wide primary prevention pro-
gramme has been implemented in Saxony in Germany.
8
The Australian ‘Life!’Study in Victoria State was devel-
oped with a direct recruitment strategy, underpinned by
social marketing and developed from the Greater Green
Triangle Translational study.
50 51
These programmes did
not achieve the same degree of weight change as the
DPP and DPS. The DPP and DPS included supervised
group PA sessions within their protocols, but service pro-
vision models have relied mainly on classroom-based
counselling.
8
The alternative approach used here may
be more effective, especially for hard-to-reach groups.
Provision of the 12 month free access to leisure card
increased the cost of the intervention and this may
make the NLNY intervention inefficient or difficult to
afford. The commissioners are considering alternatives
such as subsidised service access for continued
implementation.
Recruitment in previous diabetes prevention trials has
relied on assessment of IGT using an oral glucose toler-
ance test. This is not practical for service provision
3
and
large-scale prevention programmes have used risk
scoring methods.
52
Blood testing is required to exclude
undiagnosed T2D, but was not included in the NLNY
pilot. Addressing this limitation will be important prior to
adefinitive trial. The most convenient procedure would
be a risk score screening together with a simple blood
test (such as point of care HbA1c followed by venous
blood testing for those with high risk to exclude T2D).
5
Importance of the study: possible mechanisms and
implications for clinicians or policymakers
The NLNY feasibility study has demonstrated successful
recruitment and retention, the feasibility of collecting
individual level outcome data within a service model,
and likely effectiveness to change behavioural and inter-
mediate health outcomes.
The NHS Health Checks programme in England
offers simple tests including BMI and, where appropri-
ate, HbA1c to adults aged between 40 and 74 years.
38
NICE guidance advocates lifestyle intervention for T2D
prevention linked to NHS Health Checks.
3
Delivery cap-
acity is a major consideration in planning service provi-
sion for diabetes prevention. By citing the NLNY
intervention within local authority leisure services, we
have utilised appropriate and available facilities together
with the expertise of existing trained staff. This study
demonstrates the feasibility of an intervention model,
delivered by fitness trainers in leisure and community
settings with collection of robust outcome data. This
model has potential for scalable service provision.
Future research
The outcome data reported here are encouraging and
the next step is a formal test of effectiveness and cost-
effectiveness in a definitive trial prior to translation for
mainstream practice. The results of a qualitative process
evaluation of participants’perspectives of their behav-
ioural change
53
provide further evidence to complement
the findings reported here on feasibility, acceptability
and potential effectiveness.
CONCLUSION
High retention and positive outcomes at 12 months are
encouraging indications of the potential success of the
NLNY intervention. A controlled trial with assessment of
cost-effectiveness is warranted. The intervention provides
a potential model for sustainable service provision in the
UK and is scalable.
Acknowledgements The authors would like to thank the participants and all
the staff who helped with the study. The study was funded by a consortium
including Sport England; Middlesbrough Primary Care Trust; Public Health
North East; and Middlesbrough Council. The authors wish to thank Diabetes
10 Penn L, Ryan V, White M. BMJ Open 2013;3:e003585. doi:10.1136/bmjopen-2013-003585
Open Access
UK for their input to the Steering Group. In 2012, London hosted the Olympic
and Paralympic Games. The aspiration that the Games would encourage
greater participation in physical activity inspired the development of the ‘New
life, New You’(NLNY) intervention for T2D prevention as a health and sports
sector partnership and the project was awarded the 2012 ‘Inspire’mark. We
acknowledge the contribution made by local organisations in planning this
intervention in connection with the Olympic and Paralympic legacy.
Contributors MW was a member of the Steering Group responsible for
securing funding and for the outline plan for the NLNY intervention and
evaluation. LP contributed to the development of the NLNY pilot intervention,
designed the pilot evaluation and the qualitative study, and conducted the
qualitative interviews. VR conducted the statistical analyses. MW and VR
reviewed and contributed to the manuscript drafted by LP. All authors read
and agreed on the final version.
Funding Middlesbrough Council; Middlesbrough Primary Care Trust; Public
Health North East, Sport England. Newcastle University, Institute of Health
and Society provided funding for open access publication.
Competing interests The business case and outline plan for this pilot study
was determined by a steering committee. This included representatives from
members of the organisations that comprised the funding consortium as well
as the Principal Investigator for the evaluation, co-author MW. The detailed
development of the intervention was then progressed by a small operational
team including the evaluation researcher, co-author LP. The operational team
reported to the steering committee. The funders had no role in the collection,
analysis and interpretation of data, writing of the article or in the decision to
submit it for publication. MW, VR, and LP receive salaries from Newcastle
University, Institute of Health and Society that provides open access funding
for the publication.
Ethics approval Newcastle University Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
Open Access This is an Open Access article distributed in accordance with
the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license,
which permits others to distribute, remix, adapt, build upon this work non-
commercially, and license their derivative works on different terms, provided
the original work is properly cited and the use is non-commercial. See: http://
creativecommons.org/licenses/by-nc/3.0/
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