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ISRCTN
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ISRCTN90101501
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ClinicalTrials.gov identifier
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Public title
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The Aberdeen Behaviour Change (ABC) Weight Loss Study
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Scientific title
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Feasibility study for a randomised controlled trial of a behavioural intervention to reduce weight in obese adults with additional risk factors for chronic disease
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Acronym
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ABC weight loss study
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Serial number at source
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V2 30 June 2009
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Study hypothesis
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The purpose of the proposed study is to test the feasibility and acceptability of the intervention, measurement and trial procedures for a Randomised Controlled Trial (RCT) of a newly developed behaviour change intervention in a sample of obese adults with additional risk factors for disease recruited from GP practice lists.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approved by North of Scotland Research Ethical Committee (REC) (ref: 09/S0801/54)
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Study design
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Pilot single centre single-blinded randomised active controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Obesity with additional risk factors
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Participants - inclusion criteria
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Current inclusion criteria as of 05/04/2011:
1. Adult patients from the lists of GP practices in Grampian
2. BMI ≥ 30
3. Co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension.
Previous inclusion criteria:
1. Adult patients from the lists of GP practices in Grampian
2. BMI ≥ 35
3. Co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension.
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Participants - exclusion criteria
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1. Insufficient knowledge of the English language to take part in group interventions and use written materials
2. Conditions preventing participants from engagement in mild-moderate physical activities such as walking
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Anticipated start date
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15/09/2009
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Anticipated end date
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30/08/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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90
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Interventions
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Participants will be randomised to a group based manual based intervention or a leaflet control condition in accordance to a 2:1 allocation ratio.
1. Intervention group (Nurse-led 6 session group intervention):
The group intervention focuses on changing activity and dietary behaviours, and in turn weight and waist/hip ratio, in a sample of obese participants with additional risk factors. It is based on a comprehensive systematic review and a systematic intervention development process.
An experienced nurse will deliver six group sessions (five weekly sessions in the beginning of the intervention and a refresher session 3 weeks after session 5). The nurse will be trained and instructed in delivering the intervention in accordance with a detailed manual consisting of behaviour change techniques that have been identified as successful in terms of weight loss in our systematic review. Groups will include up to ten participants. The introduction of behaviour change techniques will follow a logical pattern with the introduction of action planning and self−monitoring in the first few sessions, followed by the introduction of subsequent techniques on a weekly basis concluding with relapse prevention towards the end of the intervention.
In addition, participants in the intervention group will receive brief encouraging letters if they miss sessions, offering to send additional study materials (e.g. self-monitoring or goal setting sheets) and the leaflets 'So you want to lose weight... for good - A guide to losing weight for men and women' and 'Get Active' issued by the British Heart Foundation.
Intervention sessions will be recorded and anonymously transcribed.
2. Control group (standard care plus written information from the British Heart Foundation):
Participants in the control group will receive the leaflets 'So you want to lose weight... for good - A guide to losing weight for men and women' and 'Get Active' issued by the British Heart Foundation.
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Primary outcome measure(s)
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Acceptability and feasibility for the pilot trial
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Secondary outcome measure(s)
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1. Changes in physical activity, diet (kcal/fat intake) and weight at 3 and 6 months (these will be primary outcomes for the main trial)
2. Changes in psychological predictors of physical activity and dietary behaviours
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Sources of funding
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Scottish Government, Chief Scientist Office (UK) (Ref: CZG/2/390)
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21897841
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Contact name
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Dr
Falko
Sniehotta
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Address
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University of Aberdeen
William Guild Building
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City/town
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Aberdeen
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Zip/Postcode
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AB24 2UB
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Country
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United Kingdom
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Sponsor
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University of Aberdeen (UK)
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Address
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King's College
Aberdeen
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City/town
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Aberdeen
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Zip/Postcode
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AB24 3FX
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Country
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United Kingdom
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Email
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e.rattray@abdn.ac.uk
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Sponsor website:
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http://www.abdn.ac.uk
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Date applied
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17/11/2009
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Last edited
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03/01/2012
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Date ISRCTN assigned
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16/03/2010
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