Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- Change in weight of partners of pregnant women
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Change in weight of partners of pregnant women
时间窗: 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.
次要结局
- 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 food, exercise and sedentary cues in the home environment(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 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)
研究者
Todd Hagobian
Associate Professor
California Polytechnic State University-San Luis Obispo