Starting Pediatric Obesity Prevention in Pregnancy - Full Text View

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:

MedlinePlus related topics: Obesity

U.S. FDA Resources

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

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
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013