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Retention program reduced drop-out, increased medication adherence in long-term weight loss trials
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A multifaceted retention program that included a dietician-led screening interview and support system and culturally adapted lifestyle modification reduced the dropout rate and improved medication adherence in three large clinical trials, recent study findings show.
“There have been many studies examining pretreatment and process predictors of drop-out in weight-loss interventions,” Linda M. Delahanty, MS, RD, of Massachusetts General Hospital Diabetes Center in Boston, and colleagues wrote. “However, few studies have utilized this evidence base to develop and implement screening tools and retention approaches to assess and manage known predictors of drop-out. Innovative retention programs such as this one that identify those individuals most at risk of drop-out and provide those who enroll with the support that they need to benefit from the treatment will contribute to both the effectiveness and cost-effectiveness of weight-loss interventions.”
Delahanty and colleagues analyzed data from 4,410 adults from 208 centers in 15 countries, participating in three phase 3, double blind, placebo-controlled clinical trials to evaluate the long-term safety and efficacy of CP-945,598 therapy (a cannabinoid receptor type 1 agonist) in patients with overweight or obesity with or without type 2 diabetes. Participants were stratified as non-U.S. English speaking, non-English speaking, U.S. without dietitian screening, or U.S. with dietitian screening. All three trials were discontinued in November 2008; by that time, most patients completed at least 1 year of dosing.
The retention program included a dietician, when possible, who screened potential volunteers (reviewing food and activity logs and conducting behavioral interviews to assess motivations), a comprehensive lifestyle-intervention program supported by culturally adapted printed materials and periodic face-to-face or telephone interactions with a dietician, and a novel dietician support system to ensure lifestyle adherence and treatment fidelity. Dieticians were trained to detect early warning signs of dropout, observe weight-change patterns, and complete food records and progress with weight and activity. Primary endpoint was the time each participant spent on-study from randomization to study medication to 1-year after randomization, dropout or study cancellation.
Over the first year, researchers observed a median retention rate of 82% across the three studies. Non-English speaking countries showed higher retention rates (89%) vs. U.S. (73%) and non-U.S. English speaking (81%) countries.
Within the U.S., behavioral screening was associated with 29% reduction in drop-out rate, according to researchers. In addition, for every 5 monthly teleconferences attended above 11, there was a 32% decrease in drop-out rate. In Cox model results restricted to U.S. centers, the presence of a dietician at screening, age and total teleconferences attended all affected dropout rate; participants without a dietician at screening were 1.33 times more likely to drop out in the U.S. vs. those screened by a dietician.
The researchers noted that, although the same program was offered at all sites, not all sites participated in the program to the same extent, and a few sites did not have access to a dietician.
“The higher retention rates achieved in the non-U.S. and non-English speaking countries vs. the U.S. may be due to a more proactive engagement of these sites in the retention program, as shown by inclusion of the dietitian in screening from the outset of the trial and overall somewhat better teleconference participation,” the researchers wrote. “A higher patient-retentive environment in terms of better adherence to trial protocols, stronger local physician-patient relationships and a largely trial-naive patient population that may gain access to a higher standard of care through trial participation may have also contributed.” – by Regina Schaffer
Disclosure: Delahanty reports serving as a paid consultant for Pfizer to design the retention strategy and lead its implementation. All other authors were employees of Pfizer at the time studies were conducted or during preparation of the manuscript.
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