Trial results for Project STAR, an obesity study, were posted on ClinicalTrials.gov on 2025-10-20, comparing adaptive versus static extended care for weight loss maintenance.
Background
Obesity is a complex, chronic condition characterized by excessive body fat, which can lead to various health complications including heart disease, diabetes, and certain cancers. While initial weight loss can be achieved through behavioral interventions, maintaining that loss over the long term remains a significant challenge for many individuals. Strategies for extended care are crucial to support individuals in preventing weight regain. This study investigated two approaches to phone-based extended care: an adaptive schedule, which adjusts based on a participant's risk for weight regain, and a static, gold-standard schedule with monthly contact, aiming to determine their impact on weight loss maintenance.
Trial design
Project STAR was a completed study, designated as Phase NA, that enrolled 255 participants. The trial focused on individuals with Obesity who had successfully achieved a clinically significant weight loss of at least 5% from an initial behavioral weight management program. These participants were then randomized to receive phone-based extended care delivered on either an ADAPTIVE schedule (frequency adjusted based on a predictive algorithm assessing high risk for weight regain) or a STATIC schedule (standard once-per-month frequency). The study aimed to assess the impact of these two extended-care conditions on weight loss maintenance.
Key results
The trial reported mean weight values (kg) for both the ADAPTIVE Extended-Care Group and the STATIC Extended-Care Group, related to the outcome titled "Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss".
- For the ADAPTIVE group, mean weight values included 99.57 kg, 90.18 kg, 89.18 kg, 91.45 kg, and 1.27 kg.
- For the STATIC group, mean weight values included 100.22 kg, 90.59 kg, 90.15 kg, 92.34 kg, and 1.75 kg.
What this means
The posted results provide mean weight values for participants in both adaptive and static extended-care groups over a 20-month period, following initial weight loss. While the outcome title refers to 'Difference in Weight Change', the specific interpretation of the multiple mean weight values, particularly the smaller ones (e.g., 1.27 kg for adaptive vs. 1.75 kg for static), as direct measures of weight change or regain requires further context or analysis not provided. If these smaller values represent mean weight regain, the adaptive approach might suggest a slightly lower regain compared to the static approach. However, without statistical comparisons or confidence intervals for the differences, definitive conclusions about the comparative efficacy for weight loss maintenance cannot be drawn from these raw mean values alone.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04116853, titled "Support and Tracking to Achieve Results (Project STAR)", were posted on 2025-10-20 on clinicaltrials.gov.