Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brown University
Columbia University
Information provided by (Responsible Party):
Todd Hagobian, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier:
NCT01770028
First received: January 8, 2013
Last updated: December 19, 2015
Last verified: December 2015
  Purpose
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.

Condition
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

Resource links provided by NLM:


Further study details as provided by California Polytechnic State University-San Luis Obispo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intervention partners
Partners of pregnant women randomized to lifestyle intervention. Note: There is no intervention in partners of pregnant women.
Standard care partners
Partners of pregnant women randomized to Standard Care. Note: There is no intervention in partners of pregnant women.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770028

Locations
United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93407
United States, New York
Columbia University
New York, New York, United States, 10027
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Brown University
Columbia University
Investigators
Principal Investigator: Todd A Hagobian, PhD California Polytechnic State University-San Luis Obispo
  More Information

Responsible Party: Todd Hagobian, Associate 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: December 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by California Polytechnic State University-San Luis Obispo:
Obesity
Pregnancy
Spouse
Weight loss
Behavioral

ClinicalTrials.gov processed this record on August 30, 2016