Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/11/2009
Date assigned
16/03/2010
Last edited
03/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Falko Sniehotta

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V2 30 June 2009

Study information

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

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

Approved by North of Scotland Research Ethical Committee (REC) (ref: 09/S0801/54)

Study design

Pilot single centre single-blinded randomised active controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/09/2009

Overall trial end date

30/08/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

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

United Kingdom

Trial participating centre

University of Aberdeen
Aberdeen
AB24 2UB
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

King's College
Aberdeen
Aberdeen
AB24 3FX
United Kingdom
e.rattray@abdn.ac.uk

Sponsor type

University/education

Website

http://www.abdn.ac.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21897841

Publication citations

  1. Results

    Sniehotta FF, Dombrowski SU, Avenell A, Johnston M, McDonald S, Murchie P, Ramsay CR, Robertson K, Araujo-Soares V, Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors., PLoS ONE, 2011, 6, 8, e23040, doi: 10.1371/journal.pone.0023040.

Additional files

Editorial Notes