Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenanceKathryn M. Ross, Meena N. Shankar, Peihua Qiu, Zibo Tian, Taylor N. Swanson, Armaan Shetty, Jaime Ruiz, Lisa Anthony, Michael G. Perri
Background
Without provision of additional intervention, most individuals regain weight after the end of weight-loss programs. Extended-care programs have been demonstrated to improve long-term weight-loss maintenance, but effects are modest.
Methods
We proposed to evaluate whether delivering extended-care telephone sessions on an ADAPTIVE (provided when individuals are deemed to be at high-risk for weight regain) versus STATIC (the once-per-month schedule typically used in extended-care programs) schedule improves weight regain after initial weight loss. Adults with obesity were initially recruited for a 16-week lifestyle weight-loss program, and those who lost ≥5 % of their initial weight were eligible for enrollment in the Project STAR maintenance trial.
Results
A total of 449 individuals (mean ± SD age = 49.5 ± 11.4 years, BMI = 35.7 ± 4.0 kg/m2, 83.5 % female, 23.4 % Black or African American, 9.8 % Hispanic) were recruited for the initial weight-loss program and lost an average of 6.4 ± 4.9 % of their initial body weight; 255 were randomized to the maintenance trial. There were no significant differences between participants randomized to the trial versus those who were not in terms of baseline weight, gender, race/ethnicity, education, or marital status, all ps > 0.05; however, participants who were randomized to the trial were older, p = .014, and reported higher incomes, p < .001.
Conclusion
Results from Project STAR will demonstrate whether providing extended-care intervention on an individually adaptable schedule improves long-term weight-loss maintenance. Moreover, the rich longitudinal dataset collected during the trial will serve as a foundation for building future predictive algorithms of weight regain and novel weight-maintenance interventions.
Authors
Jaime Ruiz
As well as: Kathryn M. Ross, Meena N. Shankar, Peihua Qiu, Zibo Tian, Taylor N. Swanson, Armaan Shetty, Lisa Anthony, Michael G. Perri
Citation
Kathryn M. Ross, Meena N. Shankar, Peihua Qiu, Zibo Tian, Taylor N. Swanson, Armaan Shetty, Jaime Ruiz, Lisa Anthony, and Michael G. Perri. 2024. Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance. Contemporary Clinical Trials 146: 107707. https://doi.org/10.1016/j.cct.2024.107707
Bibtex
@article{ROSS2024107707,
title = {Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance},
journal = {Contemporary Clinical Trials},
volume = {146},
pages = {107707},
year = {2024},
issn = {1551-7144},
doi = {https://doi.org/10.1016/j.cct.2024.107707},
url = {https://www.sciencedirect.com/science/article/pii/S1551714424002908},
author = {Kathryn M. Ross and Meena N. Shankar and Peihua Qiu and Zibo Tian and Taylor N. Swanson and Armaan Shetty and Jaime Ruiz and Lisa Anthony and Michael G. Perri},
keywords = {Obesity, Weight loss maintenance, Weight regain, Adaptive intervention},
}