Starting Pediatric Obesity Prevention in Pregnancy

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01279109
Collaborator
(none)
147
Enrollment
1
Location
2
Arms
15
Duration (Months)
9.8
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Social network building intervention
  • Behavioral: Home visit
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Starting Pediatric Obesity Prevention in Pregnancy
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

ArmIntervention/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

    Outcome Measures

    Primary Outcome Measures

    1. Gestational Weight Gain [Duration of pregnancy]

      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

    1. Social Network [2 times over 12 weeks (Week 6, Week 12)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Coleman Regional Community Center- Parks & Rec DepartmentNashvilleTennesseeUnited States37211

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01279109
    Other Study ID Numbers:
    • IRB00022051
    First Posted:
    Jan 19, 2011
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wake Forest University Health Sciences
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail147 were consented; 12 withdrew consent before randomization (reason: too much time to commit); 135 were randomized
    Arm/Group TitleSocial Network Building InterventionHome Visit
    Arm/Group DescriptionHealthy 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 pregnancyHome visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention
    Period Title: Overall Study
    STARTED6867
    COMPLETED5555
    NOT COMPLETED1312

    Baseline Characteristics

    Arm/Group TitleSocial Network Building InterventionHome VisitTotal
    Arm/Group DescriptionHealthy 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 pregnancyHome visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury preventionTotal of all reporting groups
    Overall Participants6867135
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    26.1
    (5.9)
    26.3
    (5.9)
    26.2
    (5.9)
    Sex: Female, Male (Count of Participants)
    Female
    68
    100%
    67
    100%
    135
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Latina
    48
    70.6%
    50
    74.6%
    98
    72.6%
    Caucasian
    1
    1.5%
    5
    7.5%
    6
    4.4%
    African-American
    15
    22.1%
    6
    9%
    21
    15.6%
    Asian
    1
    1.5%
    0
    0%
    1
    0.7%
    Other
    3
    4.4%
    2
    3%
    5
    3.7%
    Not self-identified
    0
    0%
    4
    6%
    4
    3%
    Region of Enrollment (participants) [Number]
    United States
    68
    100%
    67
    100%
    135
    100%
    Language preference (Count of Participants)
    English
    20
    29.4%
    17
    25.4%
    37
    27.4%
    Spanish
    41
    60.3%
    48
    71.6%
    89
    65.9%
    English AND Spanish
    7
    10.3%
    2
    3%
    9
    6.7%
    Baseline Body Mass Index Category (participants) [Number]
    Underweight
    0
    0%
    0
    0%
    0
    0%
    Normal weight
    26
    38.2%
    27
    40.3%
    53
    39.3%
    Overweight
    23
    33.8%
    23
    34.3%
    46
    34.1%
    Obese
    19
    27.9%
    17
    25.4%
    36
    26.7%

    Outcome Measures

    1. Primary Outcome
    TitleGestational Weight Gain
    DescriptionTotal 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.)
    Time FrameDuration of pregnancy

    Outcome Measure Data

    Analysis Population Description
    Analysis is presented within baseline BMI categories and overall. The Overall Number of Participants Analyzed represents those study participants for whom medical records could be abstracted in the trial (87/135).
    Arm/Group TitleSocial Network Building InterventionHome Visit
    Arm/Group DescriptionHealthy 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 pregnancyHome visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention
    Measure Participants4443
    Under IOM recommendations
    0
    0%
    0
    0%
    Within IOM recommendations
    0
    0%
    0
    0%
    Over IOM recommendations
    0
    0%
    0
    0%
    Under IOM recommendations
    8
    11.8%
    6
    9%
    Within IOM recommendations
    6
    8.8%
    3
    4.5%
    Over IOM recommendations
    1
    1.5%
    8
    11.9%
    Under IOM recommendations
    3
    4.4%
    6
    9%
    Within IOM recommendations
    7
    10.3%
    3
    4.5%
    Over IOM recommendations
    4
    5.9%
    6
    9%
    Under IOM recommendations
    4
    5.9%
    1
    1.5%
    Within IOM recommendations
    4
    5.9%
    5
    7.5%
    Over IOM recommendations
    7
    10.3%
    5
    7.5%
    Under IOM recommendations
    15
    22.1%
    13
    19.4%
    Within IOM recommendations
    17
    25%
    11
    16.4%
    Over IOM recommendations
    12
    17.6%
    19
    28.4%
    2. Secondary Outcome
    TitleSocial Network
    DescriptionNumber 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.
    Time Frame2 times over 12 weeks (Week 6, Week 12)

    Outcome Measure Data

    Analysis Population Description
    59 participants in the intervention group completed at least one wave of social network data collection. Control group participants did not have protocol-specified group sessions to evaluate.
    Arm/Group TitleSocial Network Building InterventionHome Visit
    Arm/Group DescriptionHealthy 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 pregnancyHome visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention
    Measure Participants590
    Mean (Standard Deviation) [number of discussion partner ties]
    3.56
    (2.11)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleSocial Network Building InterventionHome Visit
    Arm/Group DescriptionHealthy 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 pregnancyHome visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention
    All Cause Mortality
    Social Network Building InterventionHome Visit
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    Social Network Building InterventionHome Visit
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/68 (0%) 0/67 (0%)
    Other (Not Including Serious) Adverse Events
    Social Network Building InterventionHome Visit
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/68 (0%) 0/67 (0%)

    Limitations/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

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Sabina B. Gesell
    OrganizationWake Forest School of Medicine
    Phone336-713-8738
    Emailsgesell@wakehealth.edu
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01279109
    Other Study ID Numbers:
    • IRB00022051
    First Posted:
    Jan 19, 2011
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Aug 1, 2018