Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Fit Moms in Partners, Children, and Other Members

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Todd Hagobian, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier:
NCT01921959
First received: August 9, 2013
Last updated: December 19, 2015
Last verified: December 2015
  Purpose
The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring.

Condition Intervention
Obesity
Behavioral: Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Postpartum Weight Loss Intervention on Partner and Offspring Weight

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Weight and Weight Change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Absolute weight and change in weight


Enrollment: 300
Study Start Date: August 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Partners of intervention women
Partners of women randomized to intervention
Behavioral: Intervention
Postpartum women are randomized to intervention or control group
Partners of no intervention women
Partners of women randomized to control

Detailed Description:
Lifestyle interventions targeting overweight/obese 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 a postpartum Internet-based lifestyle intervention that target mothers' weight. The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring. The proposed study is ancillary to an ongoing clinic-randomized trial examining the efficacy of an innovative multicomponent (online, face-to-face, mobile phone) postpartum behavioral weight loss intervention in 408 low-income women in the Women, Infants, and Children program. The proposed study will determine whether partners of women randomized to the postpartum BWL intervention have greater weight losses and greater improvements in health outcomes than partners of women in standard WIC. Similar to the parent grant, assessments will occur at study entry, 6 months, and 12 months. This project is highly innovative, as it capitalizes on existing funded research and is the first study to examine ripple effects of multicomponent Internet-based intervention in low-income individuals. The project also has high impact, as the postpartum period 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 a postpartum weight-loss intervention has a positive "ripple" effects on weight and health of untreated partners and offspring/children 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:   Probability Sample
Study Population
Partners of postpartum women
Criteria

Inclusion Criteria:

  • Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the postpartum woman (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

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: NCT01921959

Locations
United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93407
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Investigators
Principal Investigator: Todd Hagobian, PhD Cal Poly San Luis Obispo
  More Information

Responsible Party: Todd Hagobian, Assistant Professor, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT01921959     History of Changes
Other Study ID Numbers: RDK101926A 
Study First Received: August 9, 2013
Last Updated: December 19, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on December 09, 2016