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

Diane C Berry; Cecilia Gonzales; Nilda Peragallo Montano; Krista M Perreira; Alice S Ammerman; Jaime Crandell; Kelly R Evenson; Myles S Faith; Hugh Waters; Crystal Linares; Yamnia I Cόrtes; Eliana M Perrin

doi:10.1186/s40795-019-0322-7

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

BMC Nutr. 2019 Dec 16:5:58. doi: 10.1186/s40795-019-0322-7. eCollection 2019.

Authors

Affiliations

¹ 1School of Nursing, The University of North Carolina at Chapel Hill, Campus Box 7460, Chapel Hill, North Carolina 27599-7460 USA.
² 2Department of Social Medicine, The University of North Carolina at Chapel Hill, 333 South Columbia Street, MacNider Hall, Room #348 / CB #7240, Chapel Hill, NC 27599-7240 USA.
³ 3Gillings School of Global Public Health, Department of Nutrition, The University of North Carolina at Chapel Hill, CB#7426, Chapel Hill, NC 27599 USA.
⁴ 4Center for Health Promotion and Disease Prevention, The University of North Carolina at Chapel Hill, CB#7426, Chapel Hill, NC 27599 USA.
⁵ 5School of Nursing, The University of North Carolina at Chapel Hill, Campus Box 7460, Chapel Hill, North Carolina 27599-8050 USA.
⁶ 6Gillings School of Global Public Health, Department of Biostatistics, The University of North Carolina at Chapel Hill, Campus Box 7460, Chapel Hill, North Carolina 27599-8050 USA.
⁷ 7Gillings School of Global Public Health, Department of Epidemiology, The University of North Carolina at Chapel Hill, Campus Box 8050, Chapel Hill, North Carolina 27599-8050 USA.
⁸ 8School and Educational Psychology, University of Buffalo Graduate School of Education, 420 Baldy Hall, North Campus, Buffalo, New York 14260-1000 USA.
⁹ 9Health Economics Research, Milken Institute, 1250 Fourth Street, Santa Monica, California 90401 USA.
¹⁰ 10Division of Primary Care, Department of Pediatrics, Duke Center for Childhood Obesity Research, Duke University School of Medicine, DUMC 102645, 146 Civitan Building, 2213 Elba Street, Durham, NC 27705 USA.

Abstract

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).

Keywords: Children; Cognitive behavioral; Hispanic; Mothers; Nutrition; Physical activity.

Associated data

ClinicalTrials.gov/NCT03866902

Abstract

Associated data

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