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Starting Pediatric Obesity Prevention in Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279109
First Posted: January 19, 2011
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Starting Pediatric Obesity Prevention in Pregnancy

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 147
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279109


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

Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Gesell SB, Tesdahl E. Data Exchange Network: The "Madre Sana" data set. Connections 2016, 35 (2), 62-65.

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01279109     History of Changes
Other Study ID Numbers: 101552
First Submitted: January 17, 2011
First Posted: January 19, 2011
Results First Submitted: January 13, 2017
Results First Posted: April 25, 2017
Last Update Posted: December 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

An individual participant data set ("The Madre Sana Data Set") and codebook are publically available and can be downloaded at:

http://www.insna.org/connections/v35/v35_2_6.html Citation: Gesell SB, Tesdahl E. Data Exchange Network: The "Madre Sana" data set. Connections 2016, 35 (2), 62-65.


Keywords provided by Wake Forest University Health Sciences:
gestational weight gain

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