Overview

This trial is active, not recruiting.

Condition obesity
Sponsor California Polytechnic State University-San Luis Obispo
Collaborator Brown University
Start date January 2013
End date March 2018
Trial size 384 participants
Trial identifier NCT01770028, 1R01HL118208

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Partners of pregnant women randomized to lifestyle intervention. Note: There is no intervention in partners of pregnant women.
Partners of pregnant women randomized to Standard Care. Note: There is no intervention in partners of pregnant women.

Primary Outcomes

Measure
Change in weight of partners of pregnant women
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

Secondary Outcomes

Measure
Percent of partners with weight change loss >5%, 10%, and 15%
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in calorie and fat intake
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in physical activity levels
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in sleep patterns and sleep hours
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in self-monitoring
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in food, exercise and sedentary cues in the home environment
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in mood
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
Change in dietary restraint
time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria:

Additional Information

Official title Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight
Principal investigator Todd A Hagobian, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by California Polytechnic State University-San Luis Obispo.