Starting Pediatric Obesity Prevention in Pregnancy

Study Overview
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Brief Summary
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The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors during pregnancy to prevent excessive gestational weight gain.

Detailed Description
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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 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 support women in gaining weight during pregnancy within their clinically recommended weight gain target.

Official Title
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Starting Pediatric Obesity Prevention in Pregnancy

Conditions
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Obesity, Pregnancy

Intervention / Treatment
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* Behavioral: Social network building intervention
* Behavioral: Home visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any race/ethnicity speak Spanish or English ≥16 years >10 and <28 weeks pregnant in prenatal care anticipating remaining in Middle Tennessee for their full gestation willing to sign a medical information release form so that we can abstract weight measures from their obstetric and pediatric records Exclusion Criteria: speak neither Spanish or English <16 years < 10 weeks or >28 weeks pregnant not in prenatal care anticipating leaving Middle Tennessee before full gestation unwilling to sign medical information release form current or past (within last 12 months) enrollment in another research program that targets weight, physical activity, nutrition

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social network building intervention<br>Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members | Behavioral: Social network building intervention<br>* Group support and 12 weekly health education/skills building sessions during pregnancy<br>* Other names: Madre Sana;|
| Active Comparator: Home visit<br>Home visits focused on preventable infant injuries | Behavioral: Home visit<br>* Three home visits during pregnancy focused on providing education on infant injury prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Weight Gain | Total weight gain during pregnancy extracted from medical record, relative to the 2009 Institute of Medicine (IOM) Weight Gain Recommendations for Pregnancy. (Reference: Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. 2009 National Academy of Sciences.) | Duration of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Network | Number of discussion partners within the intervention group. Participants were asked to identify by name any program participants with whom they had spoken about their pregnancy or pregnancy-related health behaviors. | 2 times over 12 weeks (Week 6, Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational weight gain