Tailored Weight Loss Programs for Adults With Serious Mental Illness: A Randomized Clinical Trial.

IMPORTANCE

Veterans with serious mental illness (SMI) experience a higher prevalence of obesity than the general veteran population; weight loss programs are needed that are tailored to this population.

OBJECTIVE

To evaluate a weight loss program, CoachToFit (CTF), which includes weekly calls from a Veteran Health Administration peer specialist, a Bluetooth-enabled scale and fitness tracker, and a smartphone application that provides health education and tracks steps, goals, and weight.

DESIGN, SETTING, AND

PARTICIPANTS

This randomized clinical trial was conducted within the Pittsburgh Veteran Affairs health care system and presents pre-post (6 months) analysis comparing CTF and usual care. Veterans with body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 30 or higher and diagnosis of major depressive disorder, bipolar disorder, or schizophrenia were eligible for inclusion. Exclusion criteria included history of bariatric surgery or recent psychiatric hospitalization. The study was conducted from October 1, 2020, to September 30, 2025, and data analysis was conducted from January to October 2025.

EXPOSURE: Random assignment to CTF.

MAIN OUTCOMES AND MEASURES: The primary outcomes were weight (in kg), BMI, and cardiorespiratory fitness (meters walked in 6 minutes).

RESULTS

Among the sample (n = 256), mean (SD) age was 53.5 (13.1) years, 80 participants (31.3%) were female, and 199 (77.7%) were diagnosed with major depressive disorder. Mean (SD) weight loss at 6 months was -3.2 (6.2) kg in the CTF group (n = 128) compared to -1.6 (4.9) kg in the usual care group (P = .05). After adjustment, participants in CTF experienced greater, nonsignificant weight loss compared to usual care, with an adjusted mean difference (AMD) of -1.62 kg (95% CI, -3.38 to 0.14; P = .07). For BMI, the AMD in change between groups at 6 months was -0.56 (95% CI, -1.15 to 0.03; P = .06). Change in meters walked was not statistically significant between groups, with an AMD of 3.53 m (95% CI, -12.87 to 19.92; P = .67). At 6 months, 34 participants (36.6%) from the CTF group lost 5% or more of their body weight compared to 19 (22.4%) in usual care, representing a 1.93-fold greater likelihood in adjusted analyses (95% CI, 0.96-3.91; P = .07). More participants in CTF (n = 21 [22.6%]) lost 7% or more of their body weight compared to usual care (n = 7 [8.2%]), representing a 3.9-fold greater likelihood in adjusted analyses (95% CI, 1.45-10.36; P = .007).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, a weight loss program tailored to veterans with SMI using remote technologies and paraprofessionals demonstrated the potential to help this population lose weight.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04560335.