Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors

Falko F Sniehotta, Stephan U Dombrowski, Alison Avenell, Marie Johnston, Suzanne McDonald, Peter Murchie, Craig R Ramsay, Kim Robertson, Vera Araujo-Soares

Research output: Contribution to journalArticle

8 Citations (Scopus)
4 Downloads (Pure)

Abstract

Background
Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.

Method
Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)=30 kg/m2) adults (age=18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2:1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.

Results
Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.

Conclusions
The intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.

Trial Registration
Controlled-Trials.com ISRCTN90101501
Original languageEnglish
Article numbere23040
Number of pages11
JournalPloS ONE
Volume6
Issue number8
DOIs
Publication statusPublished - Aug 2011

Fingerprint

physical activity
obesity
risk factors
Randomized Controlled Trials
body composition
body mass index
Medical problems
Chemical analysis
Obesity
glucose tolerance
Exercise
Body Composition
Morbidity
Feedback
noninsulin-dependent diabetes mellitus
Glucose
hypertension
food intake
Body Mass Index
Psychology

Cite this

Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors. / Sniehotta, Falko F; Dombrowski, Stephan U; Avenell, Alison; Johnston, Marie; McDonald, Suzanne; Murchie, Peter; Ramsay, Craig R; Robertson, Kim; Araujo-Soares, Vera.

In: PloS ONE, Vol. 6, No. 8, e23040, 08.2011.

Research output: Contribution to journalArticle

@article{65c6ca9e7ad94942b61fa297e96b04c8,
title = "Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors",
abstract = "BackgroundInterventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.MethodPilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)=30 kg/m2) adults (age=18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2:1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.ResultsOut of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63{\%} female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6{\%} of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.ConclusionsThe intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.Trial RegistrationControlled-Trials.com ISRCTN90101501",
author = "Sniehotta, {Falko F} and Dombrowski, {Stephan U} and Alison Avenell and Marie Johnston and Suzanne McDonald and Peter Murchie and Ramsay, {Craig R} and Kim Robertson and Vera Araujo-Soares",
year = "2011",
month = "8",
doi = "10.1371/journal.pone.0023040",
language = "English",
volume = "6",
journal = "PloS ONE",
issn = "1932-6203",
publisher = "PUBLIC LIBRARY SCIENCE",
number = "8",

}

TY - JOUR

T1 - Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors

AU - Sniehotta, Falko F

AU - Dombrowski, Stephan U

AU - Avenell, Alison

AU - Johnston, Marie

AU - McDonald, Suzanne

AU - Murchie, Peter

AU - Ramsay, Craig R

AU - Robertson, Kim

AU - Araujo-Soares, Vera

PY - 2011/8

Y1 - 2011/8

N2 - BackgroundInterventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.MethodPilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)=30 kg/m2) adults (age=18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2:1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.ResultsOut of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.ConclusionsThe intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.Trial RegistrationControlled-Trials.com ISRCTN90101501

AB - BackgroundInterventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.MethodPilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)=30 kg/m2) adults (age=18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2:1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.ResultsOut of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.ConclusionsThe intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.Trial RegistrationControlled-Trials.com ISRCTN90101501

U2 - 10.1371/journal.pone.0023040

DO - 10.1371/journal.pone.0023040

M3 - Article

VL - 6

JO - PloS ONE

JF - PloS ONE

SN - 1932-6203

IS - 8

M1 - e23040

ER -