ISRCTN82857232
Completed
N/A
A randomised controlled trial to test the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider
Medical Research Council (UK)0 sites1,267 target enrollmentOctober 15, 2012
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overweight and Obesity
- Sponsor
- Medical Research Council (UK)
- Enrollment
- 1267
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24943673 protocol 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28478041 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34743721/ secondary analysis (added 10/11/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35796997/ Relationship between BMI and quality of life (added 08/07/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. BMI \=28 kg/m2
- •2\. Aged \=18 years
- •3\. Willing and able to comply with the study procedures
- •For simplicity, we will not vary the BMI criteria by ethnic group.
Exclusion Criteria
- •1\. Planned or current pregnancy in the next two years
- •2\. Previous or planned bariatric surgery
- •GPs will be allowed to define any additional inclusion/exclusion criteria to meet local practice and will be asked to provide details on these for the reporting of the study. No further criteria will be imposed, thus capturing the population that would typically be referred to these treatments. Participants receiving other weight loss treatments, e.g. Orlistat, will not be excluded as such participants would still be eligible for commercial referrals in standard practice, but this will be adjusted for in the analyses. Participants will be randomised to intervention arms, and thus those receiving additional treatment should be evenly spread across the interventions and these treatments will be accounted for in the cost\-effectiveness analyses.
Outcomes
Primary Outcomes
Not specified
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