A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries

Completed

• Conditions: Obesity; Overweight and obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN85485463
• Lead Sponsor: Medical Research Council Human Nutrition Research (UK)

Brief Summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21906798 2013 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/22929209 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25826767 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29973211

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-08
• Study Completion: 2009-12-31
• Last Update Posted: 30 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 804

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.