Building Social Networks to Enhance Postpartum Weight Loss and Appropriate Infant Feeding Practices
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 13, 2018
August 1, 2018
1.3 years
March 3, 2010
August 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight (kg)
gestational weight gain and postpartum weight loss
6 times over 10 months
Secondary Outcomes (7)
Body composition
3 times over 6 months
Infant feeding practices
3 times over 6 months
Social network structure
6 times over 10 months
Waist Circumference
3 times over 6 months
Depression
6 times over 10 months
- +2 more secondary outcomes
Study Arms (2)
Social network building intervention
EXPERIMENTALHealthy lifestyle intervention focused on building reciprocal social ties between the intervention group members
Home visit
ACTIVE COMPARATORHome visits focused on preventable infant injuries
Interventions
Group support and health education sessions weekly during third trimester and once every two weeks until 6 months postpartum
Three home visits during third trimester and three during postpartum period until 6 months postpartum
Eligibility Criteria
You may qualify if:
- Latina (self-defined, or born in Central or South America)
- Spanish-speaking and/or English-speaking,
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- American Heart Associationcollaborator
Study Sites (1)
Coleman Regional Community Center - Parks & Rec Department
Nashville, Tennessee, 37211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabina B Gesell, PhD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2010
First Posted
March 5, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 13, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share