A Randomized Trial of Weight Change in a National Home Visiting Program

Introduction: Clinical trials have demonstrated significant impact in reducing weight and incidence of type 2 diabetes mellitus. However, the intensity of these trials limits their scalability to real world settings. The purpose of this study was to embed a lifestyle intervention for overweight and obese mothers within the routine practice of a parent education, home visiting organization.

Design: Pragmatic trial that used a stratified random design.

Setting/participants: Overweight or obese mothers of preschool children located across St. Louis, Missouri, enrolled in Parents As Teachers, a home visiting organization reaching women and children nationwide.

Intervention: A lifestyle intervention derived from the Diabetes Prevention Program was embedded within Parents As Teachers entitled Healthy Eating and Active Living Taught at Home (HEALTH).

Main outcome measures: Outcomes included the proportion of women that achieved 5% weight loss at 24 months and improvements in clinical and behavioral outcomes at 12 and 24 months. Participants were enrolled from 2012 to 2014 and data analysis began in 2016.

Results: Women in the usual care versus intervention group were significantly less likely to achieve 5% weight loss at 24 months (11% vs 26%, p=0.01). At 12 months, there was a 2.8-kg difference in weight between groups (p=0.0006), and by 24 months a 4.7-kg difference in weight (3.2 [SD=7.6] kg vs -1.5 [SD=8.3] kg, p=0.002); group differences in waist circumference were also evident by 12 months (2.1 [SD=8.4] cm vs -0.7 [SD=9.8] cm, p=0.04) and 24 months (3.8 [SD=10.6] cm vs -2.5 [SD=9.1] cm, p=0.005), as were improvements in behavioral outcomes. There was no difference in blood pressure between groups.

Conclusions: HEALTH achieved modest but clinically significant weight loss outcomes, and reduced weight gain in mothers of young children. The scalability of this embedded intervention offers the potential to reach mothers in Parents As Teachers programs nationally.

Trial registration: This study is registered at www.clinicaltrials.gov NCT01567033.