The Aberdeen Behaviour Change (ABC) Weight Loss Study

ISRCTN	ISRCTN90101501
DOI	https://doi.org/10.1186/ISRCTN90101501
Secondary identifying numbers	V2 30 June 2009

Submission date: 17/11/2009
Registration date: 16/03/2010
Last edited: 03/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Falko Sniehotta
Scientific

University of Aberdeen
William Guild Building
Aberdeen
AB24 2UB
United Kingdom

Study information

Study design	Pilot single centre single-blinded randomised active controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Feasibility study for a randomised controlled trial of a behavioural intervention to reduce weight in obese adults with additional risk factors for chronic disease
Study acronym	ABC weight loss study
Study hypothesis	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.
Ethics approval(s)	Approved by North of Scotland Research Ethical Committee (REC) (ref: 09/S0801/54)
Condition	Obesity with additional risk factors
Intervention	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.
Intervention type	Other
Primary outcome measure	Acceptability and feasibility for the pilot trial
Secondary outcome measures	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
Overall study start date	15/09/2009
Overall study end date	30/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	90
Participant inclusion criteria	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.
Participant exclusion criteria	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
Recruitment start date	15/09/2009
Recruitment end date	30/08/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

University of Aberdeen

Aberdeen
AB24 2UB
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

King's College
Aberdeen
Aberdeen
AB24 3FX
Scotland
United Kingdom

Email	e.rattray@abdn.ac.uk
Website	http://www.abdn.ac.uk
"ROR"	https://ror.org/016476m91

Funders

Funder type

Government

Scottish Government, Chief Scientist Office (UK) (Ref: CZG/2/390)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No