- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01081340
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
Status
Completed
Conditions
Intervention / Treatment
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.
Collaborators
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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