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

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.

Figure 1:

Trial profile

Figure 2:

Trends in participation over 3 years in the GOALS@home and Team GOALS interventions

Figure 3:. Changes in measures of adiposity over over 1 year, 2 years, and 3 years

Box and whisker plots of changes in the MMM group (shown in red) and the Health Education group (shown in blue) over 1,2, and 3 years. The mean value is shown as a + (MMM) or o (Health Education) and the median is shown as a horizontal line across the centre of the box. The box shows IQR, bounded by the 75th percentile above and the 25th percentile below. The whiskers show the highest observed value at or within 1–5 times the IQR above the 75th percentile and below the 25th percentile. From all available data (238 individuals over lyear, 233 individuals over 2 years, 227 individuals over 3 years). Means and SD at each assessment timepoint and statistical significance for adjusted differences from the intention-to-treat analysis (241 individuals) are reported in table 2. HE=Health Education. MMM=multi-level, multi-settinq, multi-component.