We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081340
First Posted: March 5, 2010
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Weight (kg) [ Time Frame: 6 times over 10 months ]
    gestational weight gain and postpartum weight loss


Secondary Outcome Measures:
  • Body composition [ Time Frame: 3 times over 6 months ]
    BIA postpartum

  • Infant feeding practices [ Time Frame: 3 times over 6 months ]
    duration of breastfeeding, use of supplemental fluids, overfeeding, timing of the introduction of solids

  • Social network structure [ Time Frame: 6 times over 10 months ]
    number and type of relationships

  • Waist Circumference [ Time Frame: 3 times over 6 months ]
  • Depression [ Time Frame: 6 times over 10 months ]
  • Nutrition [ Time Frame: 6 times over 10 months ]
    Fat/Fruit/Vegetable intake

  • Physical Activity [ Time Frame: 6 times over 10 months ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081340


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

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01081340     History of Changes
Other Study ID Numbers: 091029
First Submitted: March 3, 2010
First Posted: March 5, 2010
Last Update Posted: November 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences:
gestational weight gain
postpartum weight loss
breastfeeding
overfeeding

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms