Personalized weight loss trial comparing motivational interventions for losing weight and being more active
| ISRCTN | ISRCTN17292316 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17292316 |
| Secondary identifying numbers | FITWEIGHTRCT1 |
- Submission date
- 29/06/2016
- Registration date
- 18/07/2016
- Last edited
- 12/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
In England, two thirds of the adult population is overweight, with almost 25% of adults being classed as obese and numbers rising. Obesity costs the public £11.4 billion every year and presents a serious danger to individuals, leading to long-term health conditions such as heart disease and diabetes. It is well founded that the best way of losing weight is to combine a reduced-calorie diet with increased exercise but people often struggle to stay motivation for long enough to get lasting results. Self-help treatments and commercial programs tend to be ineffective in the long-term, with many regaining the weight they have lost soon after. Repeated failures to keep weight off can be disheartening and so effective support is needed to help people stay motivated over the longer term, developing lasting habits of healthy eating and regular exercise. A well-established counselling approach called motivational interviewing (MI) has proven to be effective for improving weight loss, but its long-term benefits are quite small. There is an urgent need for better techniques to sustain weight loss over the longer term. A new treatment called Functional Imagery Training (FIT) delivers motivational interviewing in a completely new way, building the client's motivation and confidence by training them to create and rehearse emotionally-charged mental images about their personal goal and how they will achieve it. To make healthy goals more vivid, realistic and concrete, participants are repeatedly encouraged to imagine the benefits of working towards their goals, focusing most on those benefits that will happen right away. The aim of this study is to compare the effectiveness of FIT and MI at helping people to keep off the weight they lose.
Who can participate?
Overweight adults.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive an hour-long face-to-face session of MI, focusing on either diet or physical activity changes (participant’s choice). One week later, participants undertake a 45 minute MI session via telephone with a focus on the same area as chosen in the first session. Two weeks later participants receive 10-20 minute-long booster calls every two weeks for three months and then monthly until the six month follow up to discuss progress, new goals or any issues they are facing. Those in the second group receive an hour-long face-to-face session of FIT, focusing on either diet or physical activity changes (participant’s choice). Participants also receive a 45 minute FTI telephone session two weeks later and booster calls in the same regimen as those in the first group. Participants in this group are also given the opportunity to download an app to help them with imagery training (looking at images to reinforce their mental imagery training). At the start of the study, and then again after six and 12 months, participants in both groups are weighted and measured around the weight to assess their weight loss. Participants also complete a range of questionnaires at the start of the study and after six months to assess their diet and activity levels.
What are the possible benefits and risks of participating?
Participants may benefit from increasing their physical activity levels and losing weight. There are no notable risks involved with participating in this study.
Where is the study run from?
Plymouth University (UK)
When is the study starting and how long is it expected to run for?
September 2014 to December 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Miss Linda Solbrig (public)
linda.solbrig@plymouth.ac.uk
2. Professor Jackie Andrade (scientific)
jackie.andrade@plymouth.ac.uk
Contact information
Public
Plymouth University
Graduate Office
Level 3 Link building
Drake Circus
Plymouth
PL4 8AA
United Kingdom
 ORCID ID |
0000-0003-3203-5075 |
|---|---|
| Phone | +44 7784 617079 |
| linda.solbrig@plymouth.ac.uk |
Scientific
Plymouth University
School of Psychology
Portland Square building
Plymouth
PL4 8AA
United Kingdom
| ORCID ID |
0000-0002-6626-7192 |
|---|---|
| Phone | +44 1752 584800 |
| jackie.andrade@plymouth.ac.uk |
Study information
| Study design | Single-centre two-arm partially blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Comparison of Functional Imagery Training and Motivational Interviewing for weight loss and increasing physical activity |
| Study objectives | Functional Imagery Training (FIT) will be more effective than Motivational interviewing for achieving and sustaining weight and increasing physical activity levels. |
| Ethics approval(s) | Faculty Research Ethics Committee, Health and Human Sciences, Plymouth University, 23/03/2015, ref: 14/15-389 |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | Participants are randomized to one of two groups using web-based randomisation software (https://www.randomizer.org/). Motivational Interviewing (MI) group: Participants receive one hour of MI, either focused around diet change or physical activity changes (participant led), in a face to face session. One week later they receive another MI session delivered via phone (around 45 minutes) with a focus on diet or physical activity, dependent on what they had chosen to discuss in their first session. They receive fortnightly booster calls starting two weeks after session two (10-20 minutes) giving opportunity to discuss progress, new goals or any issues participants might be facing. The MI group has no app support. Functional Imagery Training (FIT) group: Participants receive one hour of FIT, either focused around diet change or physical activity changes (participant led), in a face to face session. One week later they receive another FIT session delivered via phone (around 45 minutes) with a focus on diet or physical activity, dependent on what they had chosen to discuss in their first session. They receive fortnightly booster calls starting two weeks after session two (10-20 minutes) giving opportunity to discuss progress, new goals or any issues participants might be facing. Participants in the FIT group are given the option to download an app to help them with imagery training via practice audios, goal setting options and the opportunity to upload motivational photos. Follow up for all participants involves coming back to the same laboratory, at six months, to be weighed and measured by research assistants or placement students, not by the original experimenter, to achieve partial blinding. They will meet with the experimenter afterwards to receive £15 payment for taking part and to have a debrief. They will also be given the opportunity to find out what the other group were doing and are offered whichever treatment they had not received. |
| Intervention type | Other |
| Primary outcome measure | Weight loss is determined by measuring weight (kg) and waist circumference (cm) at baseline, 6 and 12 months. |
| Secondary outcome measures | 1. Physical activity is measured using the International Physical Activity Questionnaire (IPAQ-short) during session one and one week before follow up at six months 2. Diet is measured using the Food Frequency Questionnaire during session one and one week before follow-up at six months 3. Use of goal imagery is measured using the Thought Frequency Scale at home baseline, one week before session one and the first booster call at the end of trial week four 4. Quality of Life is measured using the QoLIAD (Global Quality of Life Assessment) during session one and one week before follow-up at six months 5. Treatment expectancy/credibility is measured using Credibility/Expectancy Questionnaire after the second session at the end of week two 6. Self-efficacy for exercise is measured using Exercice Self-Efficacy Scale (SCI) one week before session one (lab baseline) at home baseline and at the end of week four after the first booster call 7. Participant experience is measured using the participant experience questionnaire at follow-up 8. Self-efficacy for diet is measured using WELQ (Weight Efficacy Lifestyle Questionnaire) |
| Overall study start date | 15/09/2014 |
| Completion date | 18/12/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. BMI of or above 25 2. Females and males 3. Must be age 18 or above |
| Key exclusion criteria | 1. Pregnancy 2. History of eating-disorders |
| Date of first enrolment | 01/04/2016 |
| Date of final enrolment | 10/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Drake Circus
Plymouth
PL4 8AA
United Kingdom
Sponsor information
Research organisation
NIHR CLAHRC South West Peninsula
Room N14, ITTC Building
Plymouth Science Park
Derriford
Plymouth
PL6 8BX
United Kingdom
| Phone | +44 1392 726055 |
|---|---|
| penclahrc@exeter.ac.uk | |
| Website | http://clahrc-peninsula.nihr.ac.uk/contact |
"ROR" |
https://ror.org/0187kwz08 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | The raw data are available at https://zenodo.org/record/1120364. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | Yes | No |
Editorial Notes
12/11/2018: The following changes have been made:
1. Publication reference added.
2. A raw data link has been added to the publication and dissemination plan.
20/12/2017: Intention to publish date was changed from 20/06/2017 to 30/06/2018.
