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Completed

NCT Number: NCT01770028

Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

California Polytechnic State University, San Luis Obispo, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • None

Treatment and study plan

Primary outcomes

  1. Change in weight of partners of pregnant women

    Time frame: 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 outcomes

  1. 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

  2. Change in calorie and fat intake

    Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  3. Change in physical activity levels

    Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  4. Change in sleep patterns and sleep hours

    Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  5. Change in self-monitoring

    Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  6. 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

  7. Change in mood

    Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  8. Change in dietary restraint

    Time frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Collaborators

  • Brown University
  • Columbia University

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2013
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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