STRIDE: a randomized trial of a lifestyle intervention to promote weight loss among individuals taking antipsychotic medications

BMC Psychiatry

Study Protocol

Michael C Leo¹  Carla A Green¹  Nancy A Perrin¹  Bobbi Jo H Yarborough¹  Scott Stumbo¹ 

[1] Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, 97227, Portland, OR, USA;

关键词: Antipsychotic medications;    Serious mental illness;    Obesity;    Lifestyle change;    Weight loss;    Physical activity;    Diabetes risk;    Blood pressure;    Lipids;   

DOI  :  10.1186/1471-244X-13-238

 received in 2013-09-11, accepted in 2013-09-24,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundIndividuals diagnosed with serious mental illnesses are at increased risk of obesity- and cardiovascular-related morbidity and early mortality. Lifestyle interventions aimed at weight loss, even those adapted to suit the needs of this particular subgroup, have rarely produced clinically meaningful reductions in weight.Methods/designThe STRIDE study is a multi-site, parallel, two-arm randomized controlled translational trial. Participants were recruited from community mental health clinics and an integrated not-for-profit health system. Participants were randomized either to usual care or to a 12-month intervention that consisted of: 1) weekly group participation for six months covering topics on nutrition, physical activity and lifestyle changes; 2) monthly group participation for an additional six month maintenance period; and 3) individual monthly contacts from intervention group facilitators during the second six month phase. All participants are assessed at baseline, 6, 12, and 24 months post-enrollment. Process and implementation evaluations are included and the study design includes a cost-utility analysis. Participants include 200 individuals with serious mental illness with an average age of 47.1 years, a mean body-mass index of 38.3 kg/m2 and taking an average of 3.2 psychiatric medications at baseline. Baseline physiological measures included mean blood pressure (SBP/DBP) measurements of 119.2 (SD = 14.7)/79.4 (SD = 10.1); 35% reported a hypertension diagnosis and 11% took antihypertensive medications. Average lipid levels (mg/dL) were: a) triglycerides 188.0 (SD = 138.6), ranged from 43 to 1145; b) LDL 101.4 (SD = 32.9) and ranged from 17 to 185; c) HDL 45.8 (SD = 12.7) and ranged from 22 to 89; and d) total cholesterol 181.6 (SD = 39.7) and ranged from 50 to 324. Average fasting glucose levels were 108.9 (SD = 32.5) and ranged from 24 to 289. Average fasting insulin levels were 13.0 (SD=11.9) and ranged from 2 to 99.DiscussionThe STRIDE study is based on a modified version of the PREMIER comprehensive lifestyle intervention, DASH diet arm. STRIDE has successfully enrolled 200 individuals with serious mental illness in community-based settings. Baseline characteristics present a population at high risk for obesity-related negative health outcomes and demonstrate the need for evidence-based interventions to reduce these risks.Trial registrationClinical Trials.gov NCT00790517

【 授权许可】

CC BY   
© Yarborough et al.; licensee BioMed Central Ltd. 2013