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

August 9, 2018 updated by: Wake Forest University Health Sciences
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Coleman Regional Community Center - Parks & Rec Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Home visit
Home visits focused on preventable infant injuries
Three home visits during third trimester and three during postpartum period until 6 months postpartum
Experimental: Social network building intervention
Healthy lifestyle intervention focused on building reciprocal social ties between the intervention group members
Group support and health education sessions weekly during third trimester and once every two weeks until 6 months postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight (kg)
Time Frame: 6 times over 10 months
gestational weight gain and postpartum weight loss
6 times over 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 3 times over 6 months
BIA postpartum
3 times over 6 months
Infant feeding practices
Time Frame: 3 times over 6 months
duration of breastfeeding, use of supplemental fluids, overfeeding, timing of the introduction of solids
3 times over 6 months
Social network structure
Time Frame: 6 times over 10 months
number and type of relationships
6 times over 10 months
Waist Circumference
Time Frame: 3 times over 6 months
3 times over 6 months
Depression
Time Frame: 6 times over 10 months
6 times over 10 months
Nutrition
Time Frame: 6 times over 10 months
Fat/Fruit/Vegetable intake
6 times over 10 months
Physical Activity
Time Frame: 6 times over 10 months
self-report
6 times over 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sabina B Gesell, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00034677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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