Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/12/2010
Date assigned
10/03/2011
Last edited
08/09/2014
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

Prof Stephen Atkin

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Diet1

Study hypothesis

Providing energy controlled meals results in greater weight loss than following self-directed dieting behaviour.

Ethics approval

University of Hull, Department of Sports, Health and Exercise Sciences Ethics Committee, 19/10/2010

Study design

Interventional open-label randomised parallel study

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 contact Dawn Wood, HONEI, University of Hull at d.wood@hull.ac.uk to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

04/01/2011

Overall trial end date

31/05/2011

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 (80 female and 40 males)

Participant 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

Recruitment start date

04/01/2011

Recruitment end date

31/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Michael White Diabetes Centre
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Diet Chef Ltd (UK)

Sponsor details

c/o Kevin Doran
Rosewell House
2 Harvest Drive
Newbridge
Edinburgh
EH28 8QJ
United Kingdom

Sponsor type

Industry

Website

http://www.dietchef.co.uk/

Funders

Funder type

Industry

Funder name

Diet Chef Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Scottish Enterprise (UK)

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

Publication citations

Additional files

Editorial Notes