The Aberdeen Behaviour Change (ABC) Weight Loss Study

ISRCTN ISRCTN90101501
DOI https://doi.org/10.1186/ISRCTN90101501
Protocol serial number V2 30 June 2009
Sponsor University of Aberdeen (UK)
Funder Scottish Government, Chief Scientist Office (UK) (Ref: CZG/2/390)
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 of protocol

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

Primary study designInterventional
Study designPilot single centre single-blinded randomised active controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleFeasibility study for a randomised controlled trial of a behavioural intervention to reduce weight in obese adults with additional risk factors for chronic disease
Study acronymABC weight loss study
Study objectivesThe 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)
Health condition(s) or problem(s) studiedObesity with additional risk factors
InterventionParticipants 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 typeOther
Primary outcome measure(s)

Acceptability and feasibility for the pilot trial

Key secondary outcome measure(s)

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

Completion date30/08/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration90
Key inclusion criteriaCurrent 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.
Key exclusion criteria1. 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
Date of first enrolment15/09/2009
Date of final enrolment30/08/2010

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

University of Aberdeen
Aberdeen
AB24 2UB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
BMC - Part of Springer Nature Springer Nature