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OpenTrials
Completed

NCT Number: NCT01279109

Starting Pediatric Obesity Prevention in Pregnancy

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.

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Key information

Age range

16 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Coleman Regional Community Center- Parks & Rec Department

Nashville, Tennessee, 37211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social network building intervention

Behavioral

Group support and 12 weekly health education/skills building sessions during pregnancy

Other names: Madre Sana

Home Visit

Behavioral

Three home visits during pregnancy focused on providing education on infant injury prevention

Primary outcomes

  1. Gestational Weight Gain

    Time frame: Duration of pregnancy

    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.)

Secondary outcomes

  1. Social Network

    Time frame: 2 times over 12 weeks (Week 6, Week 12)

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 19, 2011
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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