Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
147 participants
INTERVENTIONAL
2011-01-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Social network building intervention
Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention
Group support and 12 weekly health education/skills building sessions during pregnancy
Home visit
Home visits focused on preventable infant injuries
Home visit
Three home visits during pregnancy focused on providing education on infant injury prevention
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* \<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
16 Years
99 Years
FEMALE
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Sabina B Gesell, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Coleman Regional Community Center- Parks & Rec Department
Nashville, Tennessee, United States
Countries
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References
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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.
Other Identifiers
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IRB00022051
Identifier Type: -
Identifier Source: org_study_id