Maximizing retention in long-term clinical trials of a weight loss agent: use of a dietitian support team.

Autor: Delahanty LM; Massachusetts General Hospital Diabetes Center Boston MA USA; Harvard Medical School Boston MA USA., Riggs M; Cato Research Durham NC USA., Klioze SS; Pfizer Global Research and Development Groton CT USA., Chew RD; Pfizer Global Research and Development Groton CT USA., England RD; Pfizer Global Research and Development Groton CT USA., Digenio A; Akcea Therapeutics Cambridge MA USA.
Jazyk: angličtina
Zdroj: Obesity science & practice [Obes Sci Pract] 2016 Sep; Vol. 2 (3), pp. 256-265. Date of Electronic Publication: 2016 Aug 02.
DOI: 10.1002/osp4.57
Abstrakt: 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/m 2 . 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.
Databáze: MEDLINE
Externí odkaz: