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Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team
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 antag...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5043498/ https://www.ncbi.nlm.nih.gov/pubmed/27708842 http://dx.doi.org/10.1002/osp4.57 |
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author | Delahanty, L. M. Riggs, M. Klioze, S. S. Chew, R. D. England, R. D. Digenio, A. |
author_facet | Delahanty, L. M. Riggs, M. Klioze, S. S. Chew, R. D. England, R. D. Digenio, A. |
author_sort | Delahanty, L. M. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5043498 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-50434982016-10-03 Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team Delahanty, L. M. Riggs, M. Klioze, S. S. Chew, R. D. England, R. D. Digenio, A. Obes Sci Pract Original Articles 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. John Wiley and Sons Inc. 2016-08-02 /pmc/articles/PMC5043498/ /pubmed/27708842 http://dx.doi.org/10.1002/osp4.57 Text en © 2016 The Authors. Obesity Science & Practice published by John Wiley & Sons Ltd, World Obesity and The Obesity Society. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Delahanty, L. M. Riggs, M. Klioze, S. S. Chew, R. D. England, R. D. Digenio, A. Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team |
title | Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team |
title_full | Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team |
title_fullStr | Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team |
title_full_unstemmed | Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team |
title_short | Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team |
title_sort | maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5043498/ https://www.ncbi.nlm.nih.gov/pubmed/27708842 http://dx.doi.org/10.1002/osp4.57 |
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