Thomas N Robinson1, Donna Matheson2, Darrell M Wilson3, Dana L Weintraub2, Jorge A Banda4, Arianna McClain5, Lee M Sanders6, William L Haskell7, K Farish Haydel2, Kristopher I Kapphahn8, Charlotte Pratt9, Kimberly P Truesdale10, June Stevens11, Manisha Desai12. 1. Stanford Solutions Science Lab, Department of Pediatrics, Stanford University, Stanford, CA, USA; Division of General Pediatrics, Department of Pediatrics, Stanford University, Stanford, CA, USA; Prevention Research Center, Stanford University, Stanford, CA, USA; Department of Medicine, Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA. Electronic address: tom.robinson@stanford.edu. 2. Stanford Solutions Science Lab, Department of Pediatrics, Stanford University, Stanford, CA, USA; Division of General Pediatrics, Department of Pediatrics, Stanford University, Stanford, CA, USA. 3. Division of Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA, USA. 4. Department of Public Health, Purdue University, West Lafayette, Indiana, USA. 5. Cruise, LLC San Francisco, CA, USA. 6. Division of General Pediatrics, Department of Pediatrics, Stanford University, Stanford, CA, USA. 7. Prevention Research Center, Stanford University, Stanford, CA, USA. 8. Quantitative Sciences Unit, Stanford University, Stanford, CA, USA. 9. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MA, USA. 10. Department of Nutrition, University of Carolina, Chapel Hill, NC, USA. 11. Department of Nutrition, University of Carolina, Chapel Hill, NC, USA; Department of Epidemiology, University of Carolina, Chapel Hill, NC, USA. 12. Quantitative Sciences Unit, Stanford University, Stanford, CA, USA; Department of Medicine, Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.
Abstract
BACKGROUND: There are few long-term studies of interventions to reduce in low socioeconomic status children with overweight or obesity. The Stanford GOALS trial evaluated a 3-year, community-based, multi-level, multi-setting, multi-component (MMM) systems intervention, to reduce weight gain among low socioeconomic status, Latinx children with overweight or obesity. METHODS: We did a two-arm, parallel group, randomised, open-label, active placebo-controlled trial with masked assessment over 3 years. Families from low-income, primarily Latinx communities in Northern California, CA, USA, with 7-11-year-old children with overweight or obesity were randomly assigned to a MMM intervention or a Health Education (HE) comparison intervention. The MMM intervention included home environment changes and behavioural counselling, community after school team sports, and reports to primary health-care providers. The primary outcome was child BMI trajectory over three years. Secondary outcomes included one- and two-year changes in BMI. This trial is registered with ClinicalTrials.govNCT01642836. FINDINGS: Between July 13, 2012, and Oct 3, 2013, 241 families were recruited and randomly assigned to MMM (n=120) or HE (n=121). Children's mean age was 9·5 (SD 1·4) years, 134 (56%) were female and 107 (44%) were male, and 236 (98%) were Latinx. 238 (99%) children participated in year 1, 233 (97%) in year 2, and 227 (94%) in year 3 of follow-up assessments. In intention-to-treat analysis, over 3 years, the difference between intervention groups in BMI trajectory was not significant (mean adjusted difference -0·25 [95% CI -0·90 to 0·40] kg/m2; Cohen's d=0.10; p=0·45). Children in the MMM intervention group gained less BMI over 1 year than did children in the HE intervention group (-0·73 [-1·07 to -0·39] kg/m2, d=0.55); the same was true over 2 years (-0·63 [-1·13 to -0·14] kg/m2; d =0.33). No differential adverse events were observed. INTERPRETATION: The MMM intervention did not reduce BMI gain versus HE over 3 years but the effects over 1 and 2 years in this rigorous trial show the promise of this systems intervention approach for reducing weight gain and cardiometabolic risk factors in low socioeconomic status communities. FUNDING: US National Institutes of Health.
BACKGROUND: There are few long-term studies of interventions to reduce in low socioeconomic status children with overweight or obesity. The Stanford GOALS trial evaluated a 3-year, community-based, multi-level, multi-setting, multi-component (MMM) systems intervention, to reduce weight gain among low socioeconomic status, Latinx children with overweight or obesity. METHODS: We did a two-arm, parallel group, randomised, open-label, active placebo-controlled trial with masked assessment over 3 years. Families from low-income, primarily Latinx communities in Northern California, CA, USA, with 7-11-year-old children with overweight or obesity were randomly assigned to a MMM intervention or a Health Education (HE) comparison intervention. The MMM intervention included home environment changes and behavioural counselling, community after school team sports, and reports to primary health-care providers. The primary outcome was child BMI trajectory over three years. Secondary outcomes included one- and two-year changes in BMI. This trial is registered with ClinicalTrials.govNCT01642836. FINDINGS: Between July 13, 2012, and Oct 3, 2013, 241 families were recruited and randomly assigned to MMM (n=120) or HE (n=121). Children's mean age was 9·5 (SD 1·4) years, 134 (56%) were female and 107 (44%) were male, and 236 (98%) were Latinx. 238 (99%) children participated in year 1, 233 (97%) in year 2, and 227 (94%) in year 3 of follow-up assessments. In intention-to-treat analysis, over 3 years, the difference between intervention groups in BMI trajectory was not significant (mean adjusted difference -0·25 [95% CI -0·90 to 0·40] kg/m2; Cohen's d=0.10; p=0·45). Children in the MMM intervention group gained less BMI over 1 year than did children in the HE intervention group (-0·73 [-1·07 to -0·39] kg/m2, d=0.55); the same was true over 2 years (-0·63 [-1·13 to -0·14] kg/m2; d =0.33). No differential adverse events were observed. INTERPRETATION: The MMM intervention did not reduce BMI gain versus HE over 3 years but the effects over 1 and 2 years in this rigorous trial show the promise of this systems intervention approach for reducing weight gain and cardiometabolic risk factors in low socioeconomic status communities. FUNDING: US National Institutes of Health.
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