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.

Study Overview

• Status: Completed
• Conditions: Obesity; Pregnancy
• Intervention / Treatment: Behavioral: Social network building intervention; Behavioral: Home visit

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.

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37211
      • Coleman Regional Community Center- Parks & Rec Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Sabina B Gesell, PhD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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 Aug;19(8):1842-52. doi: 10.1007/s10995-015-1698-x.
• Gesell SB, Tesdahl EA. The "Madre Sana" Data Set. Connect (Tor). 2015;35(2):62-65. doi: 10.17266/35.2.6. No abstract available.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: January 17, 2011
• First Submitted That Met QC Criteria: January 17, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: gestational weight gain
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: IRB00022051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No