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Building Social Networks to Enhance Postpartum Weight Loss and Appropriate Infant Feeding Practices

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Sabina Gesell, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01081340
First received: March 3, 2010
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors that 1) support women in returning to their pre-pregnancy weight after delivery; and 2) promote healthy infant feeding practices.


Condition Intervention
Obesity
 Behavioral: Social network building intervention
Behavioral: Home visit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Building Social Networks to Enhance Postpartum Weight Loss and Appropriate Infant Feeding Practices

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Weight (kg) [ Time Frame: 6 times over 10 months ] [ Designated as safety issue: No ]
    gestational weight gain and postpartum weight loss


Secondary Outcome Measures:
  • Body composition [ Time Frame: 3 times over 6 months ] [ Designated as safety issue: No ]
    BIA postpartum

  • Infant feeding practices [ Time Frame: 3 times over 6 months ] [ Designated as safety issue: No ]
    duration of breastfeeding, use of supplemental fluids, overfeeding, timing of the introduction of solids

  • Social network structure [ Time Frame: 6 times over 10 months ] [ Designated as safety issue: No ]
    number and type of relationships

  • Waist Circumference [ Time Frame: 3 times over 6 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 6 times over 10 months ] [ Designated as safety issue: No ]
  • Nutrition [ Time Frame: 6 times over 10 months ] [ Designated as safety issue: No ]
    Fat/Fruit/Vegetable intake

  • Physical Activity [ Time Frame: 6 times over 10 months ] [ Designated as safety issue: No ]
    self-report


Enrollment: 41
Study Start Date: May 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social network building intervention
Healthy lifestyle intervention focused on building reciprocal social ties between the intervention group members
 Behavioral: Social network building intervention
Group support and health education sessions weekly during third trimester and once every two weeks until 6 months postpartum
Active Comparator: Home visit
Home visits focused on preventable infant injuries
 Behavioral: Home visit
Three home visits during third trimester and three during postpartum period until 6 months postpartum

Detailed Description:

The long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. There are a number of critical periods during fetal and infant development that appear to influence the later development of obesity. Interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. This project sets the groundwork for examining whether social networks could explicitly be utilized to prevent obesity from developing by transmitting health information and health behaviors that 1) prevent postpartum weight retention in first time mothers and 2) promote appropriate infant feeding practices. The secondary aim is to assess which individual-level network-related characteristics best predict postpartum body composition and infant feeding practices.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Latina (self-defined, or born in Central or South America)
  • Spanish-speaking and/or English-speaking,
  • 18 years of age or older
  • less than 24 weeks pregnant
  • did or did not have a termination of a previous pregnancy before 20 weeks
  • has not carried a pregnancy to term
  • normal, overweight or obese (pre-pregnancy BMI >18.5 and <39)

Exclusion Criteria:

  • non-Latina,
  • non-Spanish-speaking or non-English speaking
  • less than 18 years of age
  • more than 24 weeks pregnant
  • had a termination of a previous pregnancy after 20 weeks
  • multiparous
  • underweight (pre-pregnancy BMI < 18.5)
  • morbidly obese (pre-pregnancy BMI ≥ 39)
  • currently enrolled in another program that targets weight, physical activity, or nutrition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081340

Locations
United States, Tennessee
Coleman Regional Community Center - Parks & Rec Department
Nashville, Tennessee, United States, 37211
Sponsors and Collaborators
Vanderbilt University
American Heart Association
Investigators
Principal Investigator: Sabina B Gesell, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Sabina Gesell, Research Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01081340     History of Changes
Other Study ID Numbers: 091029
Study First Received: March 3, 2010
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
gestational weight gain
postpartum weight loss
breastfeeding
overfeeding

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

ClinicalTrials.gov processed this record on May 16, 2013