Rationale, design, and methodology for the healthy mothers-healthy children study: A randomized controlled trial

Background: Hispanic women and children who become overweight or obese are at risk for developing prediabetes, type 2 diabetes, and cardiovascular disease later in life. Interdisciplinary interventions which target Hispanic women and their 3-5-year old children to improve nutrition and physical activity behaviors, manage adiposity and weight in mothers, and prevent excessive adiposity and weight gain trajectory in their children offer promise to break the intergenerational cycle. Methods: Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and physical activity program including education, coping skills training, and home-based intervention in Hispanic women and their 3-5-year old children. The program includes 6 months of continued monthly contact to help overweight and obese Hispanic mothers and their children improve adiposity, weight (trajectory for children), health behaviors (nutrition and physical activity), and self-efficacy We will partner with two federally qualified health departments in Durham and Chatham counties, North Carolina to enroll participants. We will partner with community centers to deliver the intervention. A total of 294 Hispanic women with a BMI ≥ 25 kg/m2 and 294 Hispanic 3-5-year old children with a ≥ 25th BMI percentile will be enrolled over 4 years and randomized to the experimental or equal attention control group. Data will be collected at Time 1 (0 months [baseline]) to Time 2 (9 months [completion of the intervention]) and Time 1 to Time 3 (15 months [after 6 months with no contact from the study staff]). Data collected will include adiposity and weight in mothers and children (primary outcomes). Secondary outcomes will include health behaviors and self-efficacy in the mothers and in the children. We will also evaluate the cost of delivering the program for public health departments. We will use general linear mixed models to test the hypotheses. Discussion: Decreasing overweight and obesity in Hispanic women and slowing adiposity and weight gain trajectory in young Hispanic children is urgently needed to decrease morbidity, mortality, and future health care costs. Trial registration: NCT03866902. (March 7, 2019).