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Starting Pediatric Obesity Prevention in Pregnancy

Primary Purpose

Obesity, Pregnancy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Social network building intervention

Home visit

About this trial

This is an interventional prevention trial for Obesity focused on measuring gestational weight gain

Eligibility Criteria

16 Years - 99 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Coleman Regional Community Center- Parks & Rec Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social network building intervention

Home visit

Arm Description

Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members

Home visits focused on preventable infant injuries

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01279109

First Posted

January 17, 2011

Last Updated

October 22, 2021

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01279109

Brief Title

Starting Pediatric Obesity Prevention in Pregnancy

Official Title

Starting Pediatric Obesity Prevention in Pregnancy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Pregnancy

Keywords

gestational weight gain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Social network building intervention

Arm Type

Experimental

Arm Description

Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members

Arm Title

Home visit

Arm Type

Active Comparator

Arm Description

Home visits focused on preventable infant injuries

Intervention Type

Behavioral

Intervention Name(s)

Social network building intervention

Other Intervention Name(s)

Madre Sana

Intervention Description

Group support and 12 weekly health education/skills building sessions during pregnancy

Intervention Type

Behavioral

Intervention Name(s)

Home visit

Intervention Description

Three home visits during pregnancy focused on providing education on infant injury prevention

Primary Outcome Measure Information:

Title

Gestational Weight Gain

Description

Time Frame

Duration of pregnancy

Secondary Outcome Measure Information:

Title

Social Network

Description

Time Frame

2 times over 12 weeks (Week 6, Week 12)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabina B Gesell, PhD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Coleman Regional Community Center- Parks & Rec Department

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37211

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

25649967

Citation

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.

Results Reference

result

PubMed Identifier

26577514

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.

Results Reference

result

PubMed Identifier

25874878

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 Aug;19(8):1842-52. doi: 10.1007/s10995-015-1698-x.

Results Reference

result

PubMed Identifier

27812234

Citation

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.

Results Reference

result

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Starting Pediatric Obesity Prevention in Pregnancy

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