The investigators propose to conduct a randomized controlled trial in 200 overweight/obese pregnant women and their offspring. The prenatal intervention will emphasize improving diet and physical activity. The lifestyle intervention will be delivered within an empowerment theoretical framework through a combination of group sessions, individual counseling, and by monitoring compliance to diet and physical activity to further tailor the intervention. The post-partum intervention sessions will include mothers and their offspring and will focus on breastfeeding, improving physical activity and quality of the diet and feeding practices through the first post-partum year. As part of routine prenatal care, participants in both the control and intervention arms will be given health-related advice. Since the majority of participants are expected to be eligible for the Women, Infants and Children (WIC) program, both groups will also receive assistance through WIC as per their routine policies. Our primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is infant BMI z-score at 12 months of age, and the investigators will also be evaluating several metabolic outcomes in mothers and infants.
Obesity and hyperglycemia in pregnancy are thought to impact fetal growth through over-nutrition and may stress the fetal pancreas because of the increased demand for insulin. 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. Investigators propose to conduct a randomized controlled trial in 200 overweight or obese pregnant Puerto Rican women (free of diabetes) and their infants, to favorably impact metabolic health in mothers and infants. Women presenting will be randomized to a lifestyle modification intervention or standard care control group before 16 gestational weeks. The intervention will focus on improving: (1) physical activity levels and (2) diet quality and calorie intake. The lifestyle intervention will be delivered within an empowerment theoretical framework through individualized intervention sessions, intensive group sessions, and by phone calls. The intervention will continue through the first postpartum year and will include the infants. A key objective is to evaluate whether the intervention optimizes infant BMI z-score. We will also evaluate whether the intervention increases the number of women who experience appropriate gestational weight gain, and evaluate several additional aims including relating the interventions with improved insulin sensitivity and beta-cell function in the women, and insulin concentrations adjusted for glucose in their infants.This study will also help us to identify and overcome barriers to develop effective ways of intervening during pregnancy to meaningfully improve cardio-metabolic risk trajectories of future generations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
31
The lifestyle intervention will be delivered within an empowerment framework which promotes behavioral changes by facilitating health self-efficacy, utilizing self-praise and using active coping skills to address and manage emotions. A nutrition component primarily focuses on total calories, for which energy requirements will be individually calculated for each pregnant women and on general diet quality with an emphasis on carbohydrate quality. It will also promote an overall healthy diet, emphasizing improvement of fat quality and reducing salt intake. A physical activity component focuses on promoting regular movement and minimizes the duration of bouts of sitting or lying during waking hours as well as non-exercise activity.
University of Puerto Rico Medical Science Campus
San Juan, Puerto Rico
Gestational Weight Gain
To determine if a combined lifestyle intervention of nutrition and physical activity delivered within an empowerment theoretical framework in pregnant women result in a greater percent of women who gain the appropriate amount of gestational weight gain, as defined by the Institute of Medicine, compared to those receiving standard care.
Time frame: Delivery
Does the lifestyle intervention (compared with control) affect the infant BMI z-score at 12 months of age (major
To evaluate whether the intervention influences infant BMI by comparison of infants of mothers randomized to either active intervention or control intervention
Time frame: 12 months post-partum
Estimates of beta-cell function and insulin action in the mother.
Estimation of beta-cell function, insulin resistance, and insulin sensitivity using data obtained from a frequently sampled 75g OGTT. Calculations will be based on established equations that have been validated for use in pregnancy, such as the model-based approach and the oral disposition index.
Time frame: 35,0-36,6 wks 48,0-56,0 wks pp
Maternal blood pressure during pregnancy
Time frame: 24,0-27,6 wks; 35,0-36,6 wks; Delivery
Maternal blood pressure postpartum.
Time frame: 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
Infant blood pressure
Time frame: < 48 hour pp; 4-6 wks pp; 16-24 wks pp
Post-partum weight retention
Time frame: 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
Body circumferences in mothers
Time frame: 24,0-27,6 wks 35,0-36,6 wks 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
Body circumferences in infants
Time frame: < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
Skinfold measures in infants
Time frame: < 48 hour pp 16-24 wks pp 48-56 wks pp
Sleep quality and duration in the prenatal periods in mothers
Sleep quality and duration will be assessed using an accelerometer in order to assess duration and quality of sleep
Time frame: 35,0-36,6 wks
Sleep quality and duration in the postpartum periods in mothers and infants
Sleep quality and duration will be assessed using an accelerometer in order to assess duration and quality of sleep
Time frame: 48,0-56,0 wks pp
Insulin levels adjusted for glucose levels in the infants
Time frame: < 48 hour pp 16-24 wks pp 48-56 wks pp
Developmental measures in infants
Time frame: < 48 hour pp 16-24 wks pp 48-56 wks pp
Anthropometric and growth measures in the infants
Time frame: < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
Psychosocial measures in the mothers
Time frame: 35,0-36,6 wks 48,0-56,0 wks pp
Pregnancy and Delivery complications
Time frame: 35,0-36,6 wks delivery
Fetal and neonatal adverse outcomes
Time frame: Birth and < 48 hour pp
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