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
Protocol serial number	N/A
Sponsor	Diet Chef Ltd
Funders	Diet Chef Ltd (UK), Scottish Enterprise (UK)

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

Michael White Diabetes Centre
220-232 Anlaby Road
Hull
HU3 2RW
United Kingdom

Study information

Primary study design	Interventional
Study design	Interventional open-label randomised parallel study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Weight loss at 12 weeks
Key secondary outcome measure(s)	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)
Completion date	31/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
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

United Kingdom
England

Study participating centre

Michael White Diabetes Centre

Hull
HU3 2RW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/05/2017: No publications found in PubMed, verifying study status with principal investigator