A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries
ISRCTN | ISRCTN85485463 |
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DOI | https://doi.org/10.1186/ISRCTN85485463 |
Secondary identifying numbers | 6202 |
- Submission date
- 03/08/2007
- Registration date
- 08/08/2007
- Last edited
- 06/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Susan Jebb
Scientific
Scientific
MRC Human Nutrition Research
Elsie Widdowson Laboratory
120 Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
Phone | +44 (0)1223 426356 |
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susan.jebb@mrc-hnr.cam.ac.uk |
Study information
Study design | 12-month multi-centre randomised controlled trial |
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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 the contact details to request a patient information sheet |
Scientific title | A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries |
Study acronym | WW Global Effectiveness Trial |
Study objectives | The purpose of the study is to compare the effectiveness of WeightWatchers (WW), a commercial weight-loss programme, with current standard General Practitioner (GP) weight-loss treatment for overweight adults, as informed by national guidelines in three countries (the UK, Australia and Germany). |
Ethics approval(s) | 1. UK: Nottingham Research Ethics Committee 2, 30/04/2007, ref: 07/Q2404/40 2. Australia: Sydney SW Area Health Service (RPAH Zone), 14/05/2007, ref. X07-0089 3. Germany: Ethics Committee of Fakultat (Ethikkommission de Fakultat fur Medizin der TUM), 18/05/2007, ref. 1812/07 |
Health condition(s) or problem(s) studied | Overweight and obesity |
Intervention | GP referral to WW for 12 months versus standard GP management for weight loss for 12 months. |
Intervention type | Behavioural |
Primary outcome measure | To examine the differences in weight loss at 12 months between the WW programme and standard GP management for weight loss (as informed by national guidelines) across three countries. |
Secondary outcome measures | 1. To investigate numbers of subjects losing 5% and 10% of baseline weight in each group 2. To investigate changes in a number of indicators of metabolic disease in both groups - to include body composition (bio-impedance analysis), simple indices of insulin sensitivity (HOMA-IR) , lipid profile, liver function and inflammatory markers, measured at baseline and at 6 and 12 months 3. To explore the impact of the treatments on eating behaviour (Three Factor Eating Questionnaire [TFEQ-R21]), physical activity (International Physical Activity Questionnaire short version [IPAQ-short]) and quality of life (Impact of Weight on Quality Of Life [IWQOL-lite]), assessed at baseline and at 6 and 12 months 4. To examine cost of the WW programme vs standard GP care for weight loss 5. To investigate the temporal pattern of change in body weight over all measured time points 6. To qualitatively explore participants' experiences of the two weight-loss programmes (focus groups), assessed at baseline and at 6 and 12 months |
Overall study start date | 01/07/2007 |
Completion date | 31/12/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 804 (268 per country) |
Key inclusion criteria | Men and women who are overweight and with evidence of some increased risk of obesity-related disease will be eligible for the trial. Participants will be male and female adults aged 18+ years, with a body mass index of 27 - 35 kg/m^2 and one or more of the following risk factors: 1. Family history of diabetes mellitus 2. Controlled type 2 diabetes mellitus not treated with insulin* 3. Previous gestational diabetes mellitus 4. Impaired glucose tolerance/impaired fasting glycaemia 5. Mild-moderate dyslipidaemia, or treatment for dyslipidaemia 6. Treatment for hypertension 7. Central adiposity (waist circumference greater than 88 cm in women or greater than 102 cm in men) 8. Polycystic ovary syndrome/infertility without apparent cause other than weight 9. Lower limb osteoarthritis 10. Abdominal hernia * Patients with type 2 diabetes treated with sulphonylureas will be eligible for inclusion but GPs will be advised to instruct them to closely monitor their glucose levels due to the additional risk of hypoglycaemia during weight loss, and to regularly review their medication. The number of people with diabetes recruited to the study will be limited to a maximum of 50% of the total sample. |
Key exclusion criteria | Factors which may affect weight: 1. Recent weight loss of greater than 5 kg in the previous 3 months 2. History of clinically-diagnosed eating disorder 3. Orthopaedic limitations preventing participation in regular physical activity 4. Untreated thyroid disease or greater than one change in thyroid medication over previous 6 months 5. Taking any prescription medication with known effects on appetite or weight (according to National Medicines Formulary) 6. Taking oral steroids 7. Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome acceptable) 8. Previous surgical procedure for weight loss 9. Major surgery within previous 3 months 10. Pregnancy or lactation Co-exisiting disease: 11. Insulin-treated diabetes mellitus 12. HbA1c greater than 9.0% 13. Diagnosis of type 2 diabetes within previous 6 months 14. Heart problems within previous 3 months (e.g. angina, myocardial infarction, stroke) or implanted cardiac defibrillator or pacemaker 15. Uncontrolled hypertension (greater than 160/95 mmHg) 16. Having started taking a new prescription medication within 3 months 17. Change in dosage of a prescription medication within 1 month 18. History or presence of cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrolment) Participants will also be excluded if they have participated in another clinical trial within 30 days prior to enrolment. Participants must be willing to be involved in a lifestyle-based weight-loss programme for a 12-month period, and able to attend weekly meetings (free of charge) for the duration if required. |
Date of first enrolment | 01/07/2007 |
Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Australia
- England
- Germany
- United Kingdom
Study participating centre
MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom
CB1 9NL
United Kingdom
Sponsor information
Medical Research Council Human Nutrition Research (UK)
Government
Government
c/o Dr Ann Prentice
MRC Human Nutrition Research
Elsie Widdowson Laboratory
120 Fulbourn Road
Cambridge
CB1 9YQ
United Kingdom
Phone | +44 (0)1223 426356 |
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ann.prentice@mrc-hnr.cam.ac.uk | |
Website | http://www.mrc-hnr.cam.ac.uk/ |
https://ror.org/050pqs331 |
Funders
Funder type
Industry
WeightWatchers International Inc. (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 22/10/2011 | Yes | No | |
Results article | cost-effectiveness results | 01/06/2013 | Yes | No | |
Results article | results | 01/06/2014 | Yes | No | |
Results article | results | 04/07/2018 | Yes | No |
Editorial Notes
06/07/2018: Publication reference added.