A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial

Thomas N Robinson; Donna Matheson; Darrell M Wilson; Dana L Weintraub; Jorge A Banda; Arianna McClain; Lee M Sanders; William L Haskell; K Farish Haydel; Kristopher I Kapphahn; Charlotte Pratt; Kimberly P Truesdale; June Stevens; Manisha Desai

doi:10.1016/S2213-8587(21)00084-X

A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial

Lancet Diabetes Endocrinol. 2021 Jun;9(6):336-349. doi: 10.1016/S2213-8587(21)00084-X. Epub 2021 Apr 29.

Authors

Affiliations

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.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Body Mass Index
California / epidemiology
Child
Community Participation
Exercise / physiology
Female
Hispanic or Latino / education
Humans
Male
Overweight / ethnology
Overweight / prevention & control
Overweight / therapy
Patient Care Planning
Patient Education as Topic / methods
Pediatric Obesity / ethnology*
Pediatric Obesity / prevention & control
Pediatric Obesity / therapy*
Poverty / ethnology
Social Class
Socioeconomic Factors
Sports
Weight Gain / ethnology
Weight Loss / ethnology
Weight Reduction Programs / methods*

Associated data

ClinicalTrials.gov/NCT01642836

Abstract

Publication types

MeSH terms

Associated data

Grants and funding