Starting Pediatric Obesity Prevention in Pregnancy

NCT01279109 | Completed Results DMC

• 1 other identifier: IRB00022051
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pregnancy

Keywords

gestational weight gain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Social Network

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

Study Arms (2)

Social network building intervention

EXPERIMENTAL

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

Behavioral: Social network building intervention

Home visit

ACTIVE COMPARATOR

Home visits focused on preventable infant injuries

Behavioral: Home visit

Interventions

Social network building intervention BEHAVIORAL

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

Also known as: Madre Sana

Social network building intervention

Home visit BEHAVIORAL

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

Home visit

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Coleman Regional Community Center- Parks & Rec Department

Nashville, Tennessee, 37211, United States

Location

Related 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.

  PMID: 25649967 RESULT

• 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.

  PMID: 26577514 RESULT

• 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.

  PMID: 25874878 RESULT

• 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.

  PMID: 27812234 RESULT

MeSH Terms

Conditions

Obesity; Gestational Weight Gain

Interventions

House Calls

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Limitations and Caveats

Pilot study; Low session attendance; Missing data from medical record abstractions; Loss to follow-up, possibly due to not requiring participants to attend two baseline visits prior to randomization; Generalizability may be limited to Latina women

Results Point of Contact

• Title: Dr. Sabina B. Gesell
• Organization: Wake Forest School of Medicine

sgesell@wakehealth.edu

336-713-8738

Study Officials

• Sabina B Gesell, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: April 1, 2012
• Last Updated: November 18, 2021
• Results First Posted: April 25, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)