Starting Pediatric Obesity Prevention in Pregnancy

Obesity Clinical Trial

Official title:

Starting Pediatric Obesity Prevention in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279109
• Other study ID #: IRB00022051
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: April 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity
• Pregnancy

Intervention

Behavioral:
• Social network building intervention
Group support and 12 weekly health education/skills building sessions during pregnancy
• Home visit
Three home visits during pregnancy focused on providing education on infant injury prevention

Locations

Country	Name	City	State
United States	Coleman Regional Community Center- Parks & Rec Department	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

Arinze NV, Karp SM, Gesell SB. Evaluating Provider Advice and Women's Beliefs on Total Weight Gain During Pregnancy. J Immigr Minor Health. 2016 Feb;18(1):282-6. doi: 10.1007/s10903-015-0162-8. — View Citation

Gesell SB, Katula JA, Strickland C, Vitolins MZ. Feasibility and Initial Efficacy Evaluation of a Community-Based Cognitive-Behavioral Lifestyle Intervention to Prevent Excessive Weight Gain During Pregnancy in Latina Women. Matern Child Health J. 2015 Au — View Citation

Gesell SB, Tesdahl EA. The "Madre Sana" Data Set. Connect (Tor). 2015;35(2):62-65. — View Citation

Tesdahl E, Gesell SB. Assessing the Impact of De Novo Social Ties within Health Intervention Settings: New Questions for Health Behavior Intervention Research. Clin Transl Sci. 2015 Dec;8(6):676-81. doi: 10.1111/cts.12345. Epub 2015 Nov 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)