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Maximizing retention in long-term clinical trials of a weight loss agent: use of a dietitian support team.
Obesity Science & Practice 2016 September
OBJECTIVE: High-attrition rates have been observed in long-term clinical trials of weight loss agents. We evaluated the impact of an innovative retention programme on 1-year retention.
METHODS: Three Phase 3 global multicentre clinical trials evaluated the efficacy and safety of a CB1 receptor antagonist in subjects with BMI ≥ or = 27 kg/m2 . The impact of a multifaceted retention programme including a dietitian screening interview, a comprehensive culturally adapted lifestyle modification programme, and a dietitian support system to maximize lifestyle adherence, was evaluated in 4,410 subjects from four subpopulations (non-US English-speaking, non-English-speaking, US-without dietitian screening and US-with dietitian screening) comprising 208 centres from 15 countries.
RESULTS: The median proportion retained over the first year among subjects in three protocols was 82%. Non-English-speaking countries showed higher retention rates (89%) compared with the USA (73%) and non-US English-speaking (81%) countries. Within the USA, behavioural screening was associated with 29% reduction in dropout rate; for every five monthly teleconferences attended above 11, there was a 32% decrease in dropout rate.
CONCLUSIONS: This novel retention programme greatly improved upon reported retention rates of studies conducted with other weight loss agents in long-term clinical trials. Its effectiveness should be confirmed in future trials.
METHODS: Three Phase 3 global multicentre clinical trials evaluated the efficacy and safety of a CB1 receptor antagonist in subjects with BMI ≥ or = 27 kg/m2 . The impact of a multifaceted retention programme including a dietitian screening interview, a comprehensive culturally adapted lifestyle modification programme, and a dietitian support system to maximize lifestyle adherence, was evaluated in 4,410 subjects from four subpopulations (non-US English-speaking, non-English-speaking, US-without dietitian screening and US-with dietitian screening) comprising 208 centres from 15 countries.
RESULTS: The median proportion retained over the first year among subjects in three protocols was 82%. Non-English-speaking countries showed higher retention rates (89%) compared with the USA (73%) and non-US English-speaking (81%) countries. Within the USA, behavioural screening was associated with 29% reduction in dropout rate; for every five monthly teleconferences attended above 11, there was a 32% decrease in dropout rate.
CONCLUSIONS: This novel retention programme greatly improved upon reported retention rates of studies conducted with other weight loss agents in long-term clinical trials. Its effectiveness should be confirmed in future trials.
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