Thomas N Robinson1, Donna Matheson, Manisha Desai, Darrell M Wilson, Dana L Weintraub, William L Haskell, Arianna McClain, Samuel McClure, Jorge A Banda, Lee M Sanders, K Farish Haydel, Joel D Killen. 1. Solutions Science Lab, Department of Pediatrics and Stanford Prevention Research Center, Stanford University School of Medicine, Medical School Office Building, 1265 Welch Road, 1st Floor, Stanford, CA 94305 USA; Division of General Pediatrics, Department of Pediatrics, Stanford University School of Medicine, 770 Welch Road, Suite 100, Palo Alto, CA 94304, USA; Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Medical School Office Building, 1265 Welch Road, Stanford, CA 94305, USA; Center for Policy Outcomes and Prevention, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital at Stanford, 117 Encina Commons, Suite. 182, Stanford, CA 94305, USA; Center for Healthy Weight, Stanford University School of Medicine and Lucile Packard Children's Hospital at Stanford, Medical School Office Building, 1265 Welch Road, 1st Floor, Stanford, CA 94305, USA. Electronic address: tom.robinson@stanford.edu.
Abstract
OBJECTIVE: To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. DESIGN: Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. PARTICIPANTS: Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) andtheir parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. INTERVENTIONS: Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. MAIN OUTCOME MEASURE: Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. CONCLUSIONS: The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families.
RCT Entities:
OBJECTIVE: To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obesechildren. DESIGN: Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. PARTICIPANTS: Seven through eleven year old, overweight and obesechildren (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. INTERVENTIONS: Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obesechildren, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. MAIN OUTCOME MEASURE: Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. CONCLUSIONS: The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families.
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