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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social network building intervention
Home visit
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring gestational weight gain, postpartum weight loss, breastfeeding, overfeeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Coleman Regional Community Center - Parks & Rec Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social network building intervention

Home visit

Arm Description

Healthy lifestyle intervention focused on building reciprocal social ties between the intervention group members

Home visits focused on preventable infant injuries

Outcomes

Primary Outcome Measures

Weight (kg)
gestational weight gain and postpartum weight loss

Secondary Outcome Measures

Body composition
BIA postpartum
Infant feeding practices
duration of breastfeeding, use of supplemental fluids, overfeeding, timing of the introduction of solids
Social network structure
number and type of relationships
Waist Circumference
Depression
Nutrition
Fat/Fruit/Vegetable intake
Physical Activity
self-report

Full Information

First Posted
March 3, 2010
Last Updated
August 9, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01081340
Brief Title
Building Social Networks to Enhance Postpartum Weight Loss and Appropriate Infant Feeding Practices
Official Title
Building Social Networks to Enhance Postpartum Weight Loss and Appropriate Infant Feeding Practices
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
gestational weight gain, postpartum weight loss, breastfeeding, overfeeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social network building intervention
Arm Type
Experimental
Arm Description
Healthy lifestyle intervention focused on building reciprocal social ties between the intervention group members
Arm Title
Home visit
Arm Type
Active Comparator
Arm Description
Home visits focused on preventable infant injuries
Intervention Type
Behavioral
Intervention Name(s)
Social network building intervention
Intervention Description
Group support and health education sessions weekly during third trimester and once every two weeks until 6 months postpartum
Intervention Type
Behavioral
Intervention Name(s)
Home visit
Intervention Description
Three home visits during third trimester and three during postpartum period until 6 months postpartum
Primary Outcome Measure Information:
Title
Weight (kg)
Description
gestational weight gain and postpartum weight loss
Time Frame
6 times over 10 months
Secondary Outcome Measure Information:
Title
Body composition
Description
BIA postpartum
Time Frame
3 times over 6 months
Title
Infant feeding practices
Description
duration of breastfeeding, use of supplemental fluids, overfeeding, timing of the introduction of solids
Time Frame
3 times over 6 months
Title
Social network structure
Description
number and type of relationships
Time Frame
6 times over 10 months
Title
Waist Circumference
Time Frame
3 times over 6 months
Title
Depression
Time Frame
6 times over 10 months
Title
Nutrition
Description
Fat/Fruit/Vegetable intake
Time Frame
6 times over 10 months
Title
Physical Activity
Description
self-report
Time Frame
6 times over 10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabina B Gesell, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coleman Regional Community Center - Parks & Rec Department
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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