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Starting Pediatric Obesity Prevention in Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sabina Gesell, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01279109
First received: January 17, 2011
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Obesity
Pregnancy
Behavioral: Social network building intervention
Behavioral: Home visit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Starting Pediatric Obesity Prevention in Pregnancy

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Gestational Weight Gain [ Time Frame: Duration of pregnancy ] [ Designated as safety issue: No ]
    Total weight gain during pregnancy extracted from medical record


Secondary Outcome Measures:
  • Infant feeding intentions [ Time Frame: 3 times over 12 weeks ] [ Designated as safety issue: No ]
    Mother's intent to breastfeed vs formula feed

  • Social network structure [ Time Frame: 3 times over 12 weeks ] [ Designated as safety issue: No ]
    Number and type of relationships

  • Nutrition [ Time Frame: 3 times over 12 weeks ] [ Designated as safety issue: No ]
    Fat/Fruit/Vegetable intake

  • Physical Activity [ Time Frame: 21 days over 12 weeks ] [ Designated as safety issue: No ]
    Accelerometer worn on waist during the day

  • Infant Weight at Birth [ Time Frame: 1 time after study participation ] [ Designated as safety issue: No ]
    Infant weight at birth collected through medical chart abstraction

  • Gestational Diabetes [ Time Frame: Once after delivery ] [ Designated as safety issue: No ]
    Gestational diabetes status extracted from medical record

  • Total Weeks Gestation [ Time Frame: Once after delivery ] [ Designated as safety issue: No ]
    Total weeks gestation extracted from medical record


Enrollment: 153
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social network building intervention
Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Behavioral: Social network building intervention
Group support and 12 weekly health education/skills building sessions during pregnancy
Other Name: Madre Sana
Active Comparator: Home visit
Home visits focused on preventable infant injuries
Behavioral: Home visit
Three home visits during pregnancy focused on providing education on infant injury prevention

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 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279109

Locations
United States, Tennessee
Coleman Regional Community Center- Parks & Rec Department
Nashville, Tennessee, United States, 37211
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sabina B Gesell, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Sabina Gesell, Research Assistant Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01279109     History of Changes
Other Study ID Numbers: 101552
Study First Received: January 17, 2011
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
gestational weight gain

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014