Investigating the effect of full meal provision on weight loss compared to self-directed dieting behaviour
| ISRCTN | ISRCTN29087562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29087562 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/12/2010
- Registration date
- 10/03/2011
- Last edited
- 23/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stephen Atkin
Scientific
Scientific
Michael White Diabetes Centre
220-232 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Study design | Interventional open-label randomised parallel study |
|---|---|
| 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 contact Dawn Wood, HONEI, University of Hull at d.wood@hull.ac.uk to request a patient information sheet |
| Scientific title | Investigating the effect of full meal provision on weight loss compared to self-directed dieting behaviour: an open-label randomised parallel study over 12 weeks |
| Study acronym | Diet1 |
| Study objectives | Providing energy controlled meals results in greater weight loss than following self-directed dieting behaviour. |
| Ethics approval(s) | University of Hull, Department of Sports, Health and Exercise Sciences Ethics Committee, 19/10/2010 |
| Health condition(s) or problem(s) studied | Overweight and obesity |
| Intervention | 1. Energy-controlled delivered meals 2. Self-directed delivered meals both of which supported by a dietitian The trial will aim to provide an energy deficit in each arm of 600 kcal per day in line with consensus recommendations for weight loss. The meal provision arm will be provided by Diet Chef as preprepared meals and snack; the reference or control arm will consist of a freely available diet plan based on healthy eating and a 600 kcal per day energy deficiency. Subjects will be screened at enrollment following giving consent to take part in the study. Subjects will be then randomly allocated to either weight loss strategy with the support of a dietitian. Both treatments will be for 12 weeks and follow up will be for this period; at the end of the study subjects will be offered advice on continuing weight management by the study dietitian and signposted to other services as necessary. |
| Intervention type | Other |
| Primary outcome measure | Weight loss at 12 weeks |
| Secondary outcome measures | Health status: 1. EQ-5D, measured at each visit 2. IWQoL, measured at each visit 3. MTQ, measured at each visit 4. Rotter's Locus of Control, measured at each visit 5. Waist circumference and body volume, measured at the screening visit and end of the study (12 weeks) |
| Overall study start date | 04/01/2011 |
| Completion date | 31/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 (80 female and 40 males) |
| Key inclusion criteria | 1. Presenting weight of a body mass index (BMI) of between 27 and 35 kg/m^2 2. Individuals expressing a wish to try to lose weight 3. Male or female aged between 30 and 70 years 4. No history of diabetes 5. No history of eating disorders 6. Not taking medication likely to lead to weight gain or loss, e.g. steroids, beta blockade, diuretics etc. |
| Key exclusion criteria | 1. Bariatric surgery either in planning or in history 2. Planning or currently pregnant 3. Food allergies 4. Vegetarians and vegans 5. Individuals not willing to commit to trying to lose weight for 3 months/12 weeks |
| Date of first enrolment | 04/01/2011 |
| Date of final enrolment | 31/05/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Michael White Diabetes Centre
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Sponsor information
Diet Chef Ltd
Industry
Industry
c/o Kevin Doran
Rosewell House
2 Harvest Drive
Newbridge
Edinburgh
EH28 8QJ
United Kingdom
| Website | http://www.dietchef.co.uk/ |
|---|
Funders
Funder type
Industry
Diet Chef Ltd (UK)
No information available
Scottish Enterprise (UK)
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 |
Editorial Notes
23/05/2017: No publications found in PubMed, verifying study status with principal investigator
