Clinical trial NCT01279109: Starting Pediatric Obesity Prevention in Pregnancy
Official title: Starting Pediatric Obesity Prevention in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pregnancy
Keywords: gestational weight gain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 147
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Gestational Weight Gain
timeFrame: Duration of pregnancy
Secondary outcomes:
measure: Social Network
timeFrame: 2 times over 12 weeks (Week 6, Week 12)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Coleman Regional Community Center- Parks & Rec Department
state: Tennessee
Study officials:
affiliation: Wake Forest University Health Sciences
name: Sabina B Gesell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.