Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/12/2013
Date assigned
07/01/2014
Last edited
10/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Reducing death and diseases associated with being overweight is a crucial public health goal. The aim of this study is to test the how well a very brief psychological intervention [a type of planner called a volitional help sheet (VHS)] helps to boost the effects of a community weight management programme and produce additional weight loss in a group of overweight and obese people. The VHS helps people act on their good intentions through the formation of simple IF-THEN plans that encourage a link between a critical situation (i.e., when tempted to eat) and an appropriate response (e.g., “then I will remove things from my home that remind me of eating”). The VHS has been used successfully to promote a range of health activities; this study will find out if using a booster after the initial VHS will further improve weight management.

Who can participate?
Adult men and women currently participating in a community-based weight management programme run by Bolton NHS Foundation Trust will be invited to participate.

What does the study involve?
Participants will be randomly allocated to either complete a VHS planner or to another planner that acts as a comparison (i.e., control) at the start of their weight management programme. After 5 weeks they will be randomly allocated for the second time to either the VHS planner or the comparison planner. Thoughts and feelings about eating and weight management, source of motivation and weight will be measured at 5 weeks, 3 months, 6 months and 12 months after starting the programme.

What are the possible benefits and risks of participating?
Participants who complete a VHS may benefit from their participation by losing more weight than if they took part in the weight management programme alone. There are no risks to taking part in the study.

Where is the study run from?
The weight management programmes from which participants will be recruited are held in health centres, community centres and work places in the Bolton area, Greater Manchester, UK.

When is the study starting and how long is it expected to last?
The study starts in January 2014. Participants will complete their final questionnaire 10 weeks later when their programme has finished. Weight will be recorded from the weight management programme records up to 12 months after participants have started their programme.

Who is funding the study?
The study is funded by the University of Manchester, UK.

Who is the main contact?
Dr Tracy Epton
0161 2751972
epton.tracy@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Armitage

ORCID ID

Contact details

Manchester Centre for Health Psychology
School of Psychological Sciences
University of Manchester
Coupland Street
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 2556
chris.armitage@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial to evaluate the weight loss volitional help sheet in an overweight and obese population attending a community-based weight management programme

Acronym

Study hypothesis

The main hypotheses are that:
1. at Week 5 the group (i) (completed VHS planner at start and halfway through programme) and group (ii) (VHS planner at start of programme and comparison planner halfway through the programme) will have greater weight loss than the other two conditions.
2. at Week 10 group (i) will have greater weight loss than the other 3 conditions
3. at Week 10 the group (ii) and group (iii) (comparison planner at start of the programme and VHS planner halfway through the programme) will have greater weight loss than group (iv), the control group (comparison planner at start and halfway through programme)

Ethics approval

NRES Committee North West – Greater Manchester West, 16/01/2014, ref: 13/NW/0888

Study design

Randomised controlled trial with the between-persons factor of condition with four levels

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

A psychological health intervention on an overweight and obese population

Intervention

Participants will be randomised to two groups: volitional help sheet (VHS) planner and a comparison planner (control). After five weeks, they will again be randomised to the above two groups. The four study arms are:
1. VHS planner at the start and halfway through the programme
2. VHS planner at the start of the programme and comparison planner halfway through the programme
3. Comparison planner at the start of the programme and VHS planner halfway through the programme
4. Comparison planner at the start and halfway through the programme (control)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Weight loss at the end of the weight management programme (objectively measured weight)

Secondary outcome measures

1. Weight loss and waist circumference at five weeks (T2) into the weight management programme (objectively measured)
2. Intentions to lose weight measured using a two-item questionnaire from Armitage, 2013 at T2 and T3 (at the end of the weight management programme)
3. Weight loss self-efficacy at T2 and T3 (a four-item questionnaire from Armitage, 2013)
4. Self-regulation strategies used at T2 and T3 (action control scale from Sniehotta et al., 2005)
5. Eating habit scale at T2 and T3 (Self-reported habit index adapted from Verplanken & Orbell, 2003)
6. Source of motivation for weight loss at T2 and T3 (weight loss treatment self-regulation questionnaire; Williams et al., 2013)
7. Situations experienced and strategies used at T3 (self-report questionnaire from Armitage, 2013)

Weight loss and waist circumference measured at 3, 6 and 12 months after the start of the programme.

Overall trial start date

01/07/2014

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult
2. Able to understand written and verbal English
3. Competent to provide informed consent
4. Attending a community-based weight management programme run by Bolton NHS Foundation Trust

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

179

Participant exclusion criteria

1. Unable to understand written and verbal English
2. Not competent to provide informed consent

Recruitment start date

01/07/2014

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Centre for Health Psychology
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Nalin Thakker
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Manchester (UK) - Manchester Centre for Health Psychology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 10/03/2016 the following changes were made to the trial record: 1. The overall trial start date was changed from 06/01/2014 to 01/07/2014. 2. The overall trial end date was changed from 06/05/2015 to 30/09/2016.