ISRCTN85485463
Completed
Not Applicable
A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries
Medical Research Council Human Nutrition Research (UK)0 sites804 target enrollmentAugust 8, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight and obesity
- Sponsor
- Medical Research Council Human Nutrition Research (UK)
- Enrollment
- 804
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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