Obesity and hyperglycemia in pregnancy impact fetal growth through over-nutrition and may stress the feta pancreas. Such intrauterine programming events affect birth weight and raise the offspring's risk trajectory for future obesity, type 2 diabetes, cardiovascular disease and premature death. This vicious cycle, through which female offspring of mothers with diabetes are themselves more likely to develop diabetes prior to delivery, transmits the burden of morbidity from one generation to the next. This tragic but preventable trend likely underlies the alarming increase in gestational and type 2 diabetes. We propose to conduct a randomized controlled trial in 400 overweight or obese pregnant Puerto Rican women (free of diabetes) and their infants, to favorably impact metabolic health in mothers and infants. Women presenting before 20 gestational weeks will be block randomized to a lifestyle modification intervention or standard care control group. Puerto Rico is a predominantly Hispanic U.S. territory with among the lowest levels of physical activity and fruit, vegetable and whole grain intake, and the highest rates of diabetes, childhood obesity and infant mortality of all U.S. jurisdictions; nevertheless, recruitment rates for research studies ae higher here than elsewhere in the U.S.. The intervention will be conducted in pregnant women and their infants, focusing on improving: (1) physical activity levels, (2) diet quality and calori intake, (3) behavioral imprinting and (4) prenatal care. The intervention will be delivered through six intensive core group sessions (10 participants per group), followed by booster sessions and phone calls, and will continue during lactation through the first postpartum year. We will evaluate whether the combined intervention will: (1) increase the percent of women with adequate gestational weight gain, (2) optimize early infant growth and (3) achieve adequate retention and compliance. As secondary aims, we will evaluate whether the interventions improve insulin sensitivity and beta-cell function in the women and fasting insulin concentrations in their infants. This study will also help us to work through the logistical and other barriers to develop more effective ways to intervene during pregnancy to maximally reduce cardio-metabolic risk trajectories of future generations. Undertaking this study in Puerto Rico will address a major health disparity common to many parts of the US, whilst also advancing knowledge about how early life risk factors could be influenced to reduce metabolic risk in young women and their offspring.

Public Health Relevance

Healthy diet, physical activity and weight loss can substantially delay the onset of type 2 diabetes among overweight and obese adults. Since many risk raising events occur in utero and infancy, diabetes prevention strategies early in life are likely to have a much higher public health impact. Our study, which will focus on improving nutrition and increasing physical activity during pregnancy and in early life, is likely to improve diabetes risk trajectories and promote much needed public health strategies in a disadvantaged population

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
4U01HD072834-05
Application #
8918707
Study Section
Special Emphasis Panel (ZDK1-GRB-N (O1)S)
Program Officer
Raju, Tonse N
Project Start
2011-09-30
Project End
2017-07-31
Budget Start
2016-08-01
Budget End
2017-07-31
Support Year
5
Fiscal Year
2016
Total Cost
$723,267
Indirect Cost
$217,244
Name
University of Puerto Rico Med Sciences
Department
Type
Schools of Medicine
DUNS #
948108063
City
San Juan
State
PR
Country
United States
Zip Code
00936
Abraham, Manjusha; Collins, Christina A; Flewelling, Scott et al. (2018) Mitochondrial inefficiency in infants born to overweight African-American mothers. Int J Obes (Lond) 42:1306-1316
Gallagher, Dympna; Rosenn, Barak; Toro-Ramos, Tatiana et al. (2018) Greater Neonatal Fat-Free Mass and Similar Fat Mass Following a Randomized Trial to Control Excess Gestational Weight Gain. Obesity (Silver Spring) 26:578-587
Lewkowitz, Adam K; López, Julia D; Stein, Richard I et al. (2018) Effect of a Home-Based Lifestyle Intervention on Breastfeeding Initiation Among Socioeconomically Disadvantaged African American Women with Overweight or Obesity. Breastfeed Med 13:418-425
Sutton, Elizabeth F; Morrison, Christopher D; Stephens, Jacqueline M et al. (2018) Fibroblast growth factor 21, adiposity, and macronutrient balance in a healthy, pregnant population with overweight and obesity. Endocr Res 43:275-283
Peaceman, Alan M; Clifton, Rebecca G; Phelan, Suzanne et al. (2018) Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. Obesity (Silver Spring) 26:1396-1404
Sutton, Elizabeth F; Cain, Loren E; Vallo, Porsha M et al. (2017) Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials. Obstet Gynecol 129:554-559
Redman, Leanne M; Gilmore, L Anne; Breaux, Jeffrey et al. (2017) Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth 5:e133
Torres, Roxana; Soltero, Sandra; Trak, Maria Angelica et al. (2016) Lifestyle modification intervention for overweight and obese Hispanic pregnant women: development, implementation, lessons learned and future applications. Contemp Clin Trials Commun 3:111-116
Clifton, Rebecca G; Evans, Mary; Cahill, Alison G et al. (2016) Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring) 24:305-13
Zorrilla, Carmen D; Rabionet, Silvia E; Mosquera, Ana M et al. (2012) Biomedical HIV prevention strategies: state of the art and implications for public health policy in the Caribbean. P R Health Sci J 31:170-9