Trial record 19 of 212 for:    (childhood OR child) AND (female OR girl) AND obesity NOT (male OR men)

Fit Moms in Partners, Children, and Other Members

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by California Polytechnic State University-San Luis Obispo
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: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition
Obesity

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 will be measured to the nearest 0.1 kg using a calibrated and portable standard digital scale


Secondary Outcome Measures:
  • Change from baseline in mood [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The Beck Depression Inventory-II will be used to examine change from baseline levels of mood and depressive symptoms

  • Change from Baseline in Physical Activity Levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from Baseline in Physical Activity Levels will be assessed using the Actigraph accelerometer.

  • Change from Baseline in Dietary Intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from Baseline in Dietary Intake will be assessed using 24-hour recalls.

  • Change from baseline in Dietary Restraint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in dietary restraint will be assessed by the Eating Inventory questionnaire

  • Change from baseline in self-efficacy [ Time Frame: 12 ] [ Designated as safety issue: No ]
    Change from baseline in self-efficacy will be assessed using Weight Efficacy Lifestyle Questionnaire.

  • Change from baseline in stress [ Time Frame: 12 ] [ Designated as safety issue: No ]
    Change from baseline in stress will be assessed using the short-form of the Perceived Stress Scale.

  • Change from baseline in sleep [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in sleep will be assessed by the general sleep disturbance questionnaire

  • Change from baseline in partner connectedness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Partners will be asked to complete a questionnaire adapted from Look AHEAD, which assesses frequency of grocery shopping by self and members in the home, number of meals shared with postpartum partner and others in the home, and whether the meal is eaten inside and outside the home, and frequency of cooking (in reference to self and others in the home).

  • Change from baseline in relationship status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The Dyadic Adjustment Scale will be used to assess change from baseline in relationship stability, intimacy and history.


Estimated Enrollment: 200
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
Partners of intervention women
Partners of no intervention women

  Eligibility

Ages Eligible for Study:   18 Years and older
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:

  • None
  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

Contacts
Contact: Todd Hagobian, PhD 805.756.7511 thagobia@calpoly.edu
Contact: Suzanne Phelan, PhD 805.756.2087 sphelan@calpoly.edu

Locations
United States, California
California Polytechnic State University Recruiting
San Luis Obispo, California, United States, 93407
Contact: Todd Hagobian, PhD    805-756-7511    thagobia@calpoly.edu   
Contact: Suzanne Phelan, PhD    805.756.2087    sphelan@calpoly.edu   
Principal Investigator: Todd Hagobian, PhD         
Sub-Investigator: Suzanne Phelan, PhD         
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Investigators
Principal Investigator: Todd Hagobian, PhD Cal Poly San Luis Obispo
  More Information

No publications provided

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: August 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014