Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight
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Purpose
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; 3U01DK094418-01S1, PIs Martin and Redman) 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.
| Condition |
|---|
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Obesity |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 19 Months |
| Official Title: | Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight |
- Change in weight of partners of pregnant women [ Time Frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]
- Change in calorie and fat intake [ Time Frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum ] [ Designated as safety issue: No ]
- Change in physical activity levels [ Time Frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum ] [ Designated as safety issue: No ]
- Change in sleep patterns and sleep hours [ Time Frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum ] [ Designated as safety issue: No ]
- Change in self-monitoring [ Time Frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Change in mood [ Time Frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum ] [ Designated as safety issue: No ]
- Change in dietary restraint [ Time Frame: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 384 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | April 2018 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Partners of intervention pregnant women
Partners of pregnant women randomized to lifestyle intervention. Note: There is no intervention in partners of pregnant women.
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Partners of no intervention pregnant women
Partners of pregnant women randomized to Standard Care. Note: There is no intervention in partners of pregnant women.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
This study uses a randomized repeated measures design. Partners will be categorized based on randomized status of their pregnant partner (in the parent grants; NIH 1U01HL114377-01, PI Phelan; NIH 3U01DK094418-01S1, PIs Redman and Martin). Partner participation in the ancillary study will not be mandatory for participation in the parent grant. NOTE: There is no intervention in partners.
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
Contacts and Locations| Contact: Todd A Hagobian, PhD | 805-756-7511 | thagobia@calpoly.edu |
| Contact: Suzanne Phelan, PhD | 805-756-2087 | sphelan@calpoly.edu |
| United States, California | |
| California Polytechnic State University | Recruiting |
| San Luis Obispo, California, United States, 93407 | |
| Contact: Todd A Hagobian, PhD 805-756-7511 thagobia@calpoly.edu | |
| Sub-Investigator: Suzanne Phelan, PhD | |
| United States, Louisiana | |
| Pennington Biomedical Research Center | Recruiting |
| Baton Rouge, Louisiana, United States, 70808 | |
| Contact: Leanne Redman, PhD 225-763-0947 Leanne.Redman@pbrc.edu | |
| Contact: Corby Martin, PhD (225) 763-2585 Corby.Martin@pbrc.edu | |
| United States, Rhode Island | |
| Miriam Hospital | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| Contact: Rena R Wing, PhD 401-793-8959 rwing@calpoly.edu | |
| Principal Investigator: | Todd A Hagobian, PhD | California Polytechnic State University-San Luis Obispo |
More Information
No publications provided
| Responsible Party: | Todd Hagobian, Assistant Professor, California Polytechnic State University-San Luis Obispo |
| ClinicalTrials.gov Identifier: | NCT01770028 History of Changes |
| Other Study ID Numbers: | 1R01HL118208 |
| Study First Received: | January 8, 2013 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by California Polytechnic State University-San Luis Obispo:
|
Obesity Pregnancy Spouse Weight loss Behavioral |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013