Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight
- Conditions
- Obesity
- Registration Number
- NCT01770028
- Lead Sponsor
- California Polytechnic State University-San Luis Obispo
- Brief Summary
The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home. We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months. Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters.
- Detailed Description
Lifestyle interventions targeting overweight individuals can produce positive "ripple" effects on untreated overweight partners in the home. Interestingly, ripple effects on partners' weight appear most pronounced when the interventions target women. Women, and mothers in particular, remain the primary "nutritional gatekeepers" of the home. Despite widespread recognition that motherhood is a powerful motivator for behavior changes, no study to date has examined the "ripple" effects of prenatal lifestyle interventions that target mothers' gestational weight gain. The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home. The proposed study is ancillary to two randomized phase III clinical trials in the LIFE-moms consortium (1U01HL114377-01, PI Phelan; 3U01DK094463-03S1, PIs Pi-Sunyer and Gallagher) that are examining the efficacy of multi-component lifestyle interventions to prevent excessive gestational weight gain in a total of 650 overweight/obese women. In this ancillary study, partners' weight, home environment, and psychosocial behaviors will be assessed when their pregnant partners are \~13 weeks gestation (study entry), 35 weeks gestation and at 6 and 12 months postpartum. We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months. Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters. This project is highly innovative, as it capitalizes on existing funded research and is the first study to examine ripple effects of multicomponent prenatal interventions. The project also has high impact, as pregnancy is a powerful motivator for behavior and environmental changes in the home; and, if positive ripple effects occur, the field of obesity treatment and prevention could move beyond focus on individual level to the often unrecognized interpersonal effects of lifestyle interventions. PUBLIC HEALTH RELEVANCE: This research project will examine whether interventions to prevent excessive gestational weight gain have positive "ripple" effects on the health of untreated partners in the home.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the pregnant women (enrolled in the parent grant) for the previous 3 months or recently been married and living in the home
- ≥18 years
- willing to provide informed consent/assent
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in weight of partners of pregnant women 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum Change in weight of partners of pregnant women randomized to the lifestyle intervention, relative to partners of pregnant women of standard care, from 13 weeks gestation to 35 weeks gestation and 6 and 12-months postpartum.
- Secondary Outcome Measures
Name Time Method Percent of partners with weight change loss >5%, 10%, and 15% 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum Change in sleep patterns and sleep hours 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum Change in self-monitoring 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum Change in mood 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum Change in calorie and fat intake 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum Change in food, exercise and sedentary cues in the home environment 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum Change in physical activity levels 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum Change in dietary restraint 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Trial Locations
- Locations (3)
California Polytechnic State University
🇺🇸San Luis Obispo, California, United States
Columbia University
🇺🇸New York, New York, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States