Objectives
STRIDE assessed whether a lifestyle intervention, tailored for individuals with serious mental illnesses, reduced weight and diabetes risk.
Methods
A multi-site, parallel, two-arm randomized controlled trial in community settings and an integrated health plan. Inclusion criteria: Age ≥18; taking antipsychotic medication for ≥30 days; BMI ≥27. Exclusions: significant cognitive impairment; pregnancy/breastfeeding; recent psychiatric hospitalization, bariatric surgery, cancer, heart attack or stroke. The intervention emphasized moderate caloric reduction, DASH diet, and physical activity. Blinded staff collected data at baseline, 6, and 12 months.
Results
Participants (56 men, 144 women), mean age = 47.2(SD =10.6), were randomized to usual care (n =96) or a 6-month weekly group intervention plus 6 monthly maintenance sessions (n =104). 181 participants (90.5%) completed 6-month, and 170 (85%) completed 12-month assessments, without differential attrition. Participants attended 14.5 of 24 sessions over 6 months. Intent-to-treat analyses found intervention participants lost 4.4 kg more than control participants from baseline to 6 months (95% CI [−6.96 kg, −1.78 kg]), and 2.6 kg more than controls (95% CI −5.14 kg, −0.07 kg] from baseline to 12 months. At 12 months, fasting glucose levels in controls had increased from 106.0 mg/dL to 109.5 mg/dL and decreased in intervention participants, from 106.3 mg/dL to 100.4 mg/dL. No serious adverse events were study-related; medical hospitalizations were reduced in the intervention group (6.7%) compared to controls (18.8%)(χ2= 6.66, p = 0.01).
Conclusions
Individuals taking antipsychotic medications can lose weight and improve fasting glucose levels. Increasing reach of the intervention is an important future step.
Funding Source
National Institute of Diabetes and Digestive and Kidney Diseases, Grant R18DK076775
Trial Registration
Clinical Trials.gov, NCT00790517; http://clinicaltrials.gov/ct2/show/NCT00790517?term=STRIDE&rank=1