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| A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN85485463 |
| Date ISRCTN assigned | 08/08/2007 |
| Local reference number(s) | 6202 |
| Public title | A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries |
| Scientific title | |
| Acronym | WW Global Effectiveness Trial |
| Disease/condition/study domain | Overweight and obesity |
| Study hypothesis | 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 3 countries (the UK, Australia and Germany). |
| Design/methodology | 12-month, multi-centre, randomised controlled trial. |
| Research ethics review | UK: Nottingham Research Ethics Committee 2, 30/04/2007 (ref: 07/Q2404/40) Australia: Sydney SW Area Health Service (RPAH Zone), 14/05/2007 (ref. X07-0089) Germany: Ethics Committee of Fakultat (Ethikkommission de Fakultat fur Medizin der TUM), 18/05/2007 (ref. 1812/07) |
| Countries of trial | United Kingdom, Australia and Germany. |
| Participants - 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/m2 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 >88 cm in women or >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. |
| Participants - exclusion criteria | Factors which may affect weight: 1. Recent weight loss of >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 >1 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 >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 (>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. |
| Patient information material | |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Ongoing |
| Target number of participants | 804 (268 per country) |
| Interventions | GP referral to WW for 12 months versus standard GP management for weight loss for 12 months. |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | WeightWatchers International Inc. |
| Sponsor name | Medical Research Council Human Nutrition Research (UK) |
| Sponsor details | c/o Dr Ann Prentice MRC Human Nutrition Research Elsie Widdowson Laboratory 120 Fulbourn Road Cambridge United Kingdom CB1 9YQ |
| Sponsor telephone | 0044 1223 426356 |
| Sponsor fax | 0044 1223 437515 |
| Sponsor email | ann.prentice@mrc-hnr.cam.ac.uk |
| Sponsor website | http://www.mrc-hnr.cam.ac.uk/ |
| Contact name | Dr Susan Jebb |
| Contact details | MRC Human Nutrition Research Elsie Widdowson Laboratory 120 Fulbourn Road Cambridge United Kingdom CB1 9NL |
| Contact telephone | +44 1223 426356 |
| Contact fax | +44 1223 437515 |
| Contact email | susan.jebb@mrc-hnr.cam.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN85485463 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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