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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01081340
• Collaborator: American Heart Association (Other)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Social network building intervention; Behavioral: Home visit	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• 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
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Weight (kg) [6 times over 10 months]

   gestational weight gain and postpartum weight loss

Secondary Outcome Measures

1. Body composition [3 times over 6 months]

   BIA postpartum

2. Infant feeding practices [3 times over 6 months]

   duration of breastfeeding, use of supplemental fluids, overfeeding, timing of the introduction of solids

3. Social network structure [6 times over 10 months]

   number and type of relationships

4. Waist Circumference [3 times over 6 months]

5. Depression [6 times over 10 months]

6. Nutrition [6 times over 10 months]

   Fat/Fruit/Vegetable intake

7. Physical Activity [6 times over 10 months]

   self-report

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01081340
• Other Study ID Numbers: IRB00034677
• First Posted: Mar 5, 2010
• Last Update Posted: Aug 13, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: gestational weight gain; postpartum weight loss; breastfeeding; overfeeding
• Additional relevant MeSH terms: Weight Loss

Study Results

No Results Posted as of Aug 13, 2018