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Healthy for Two, Healthy for You (H42/H4U)

Primary Purpose

Weight Gain, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy for Two, Healthy for You
Health Education
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Mothers:

    • BMI >= 18.5 kg/m2 at time of eligibility screening
    • Age >=18
    • Able to provide informed consent
    • 12 weeks gestation or earlier
    • English speaking
    • Insurance type
    • Willing to provide address and >=2 contact people
    • Consistent use of a personal smartphone and willingness to use for health behavior tracking as part of the study
    • Patient at a participating prenatal clinical site
    • Access to internet (including public library and smartphone)
    • Demonstrated ability to track caloric intake for 4 days
    • Singleton pregnancy

Infants:

• Born during Mother's enrollment in study

Exclusion Criteria:

  • • Type 1 or type 2 diabetes, pre-pregnancy or gestational diabetes, diagnosed prior to start of intervention (14 weeks gestation)

    • Multiple fetuses
    • Prior history of severe preeclampsia, pre-term birth (before 32 weeks gestation)
    • Prior history of or current diagnosis of incompetent cervix
    • Poorly controlled blood pressure (>160/100)
    • Unable to walk 1 block without pain, shortness of breath
    • Serious medication condition hindering use of recommendations for pregnancy weight gain
    • Not cleared by study's maternal-fetal medicine or treating obstetrician
    • Planning to relocate from areas in next 2 years
    • Psychiatric or substance use related hospitalization in past 1 year
    • (There is no exclusion criteria for the infants)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Healthy for Two, Healthy for You

    Pregnancy Health Education

    Arm Description

    Remotely delivered behavioral health coaching in pregnancy and postpartum

    Single health education visit with study staff member

    Outcomes

    Primary Outcome Measures

    Gestational weight gain
    Gestational weight gain is calculated as weight, in pounds recorded at 37 weeks gestation minus the baseline weight recorded by 14 weeks gestation.

    Secondary Outcome Measures

    Postpartum weight retention
    Postpartum weight retention is calculated as weight, in pounds, recorded at 3 months after delivery minus the weight recorded at baseline (by 14 weeks gestation).

    Full Information

    First Posted
    May 29, 2018
    Last Updated
    May 29, 2018
    Sponsor
    Johns Hopkins University
    Collaborators
    Mid-Atlantic Nutrition Obesity Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03551054
    Brief Title
    Healthy for Two, Healthy for You
    Acronym
    H42/H4U
    Official Title
    Healthy for Two, Healthy for You: A Pilot Health Coaching Intervention for Pregnant Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 22, 2016 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    March 27, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    Mid-Atlantic Nutrition Obesity Research Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Investigators conducted a pilot feasibility and acceptability randomized controlled trial of a remotely delivered behavioral health coaching program in pregnancy and postpartum.
    Detailed Description
    Half of pregnant women are overweight or obese. Obesity disproportionately impacts low-income women and women of racial and ethnic minorities. Maternal obesity is linked with adverse perinatal outcomes, including gestational diabetes and preeclampsia, as well as longer-term health problems such as obesity in offspring and maternal cardiovascular disease. Pregnancy provides a unique opportunity to engage women in improving their health behaviors because women are motivated to protect the health of their babies and have frequent interactions with the healthcare system. Advances in behavioral weight management and obesity prevention have not yet been translated into real-world prenatal care settings. Our team was recently supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded Nutrition and Obesity Research Center Pilot and Feasibility program to adapt an evidence-based telephonic health coaching program for pregnant women. Investigators conducted 20 in-depth interviews with patients and providers to gain valuable feedback to inform the intervention design and delivery, and have put together a multi-disciplinary team to adapt the intervention. Investiagtors developed the intervention specific for pregnancy and postpartum based on this feedback and are testing the intervention, Healthy for Two / Healthy for You, to assess feasibility and acceptability.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Gain, Pregnancy Related

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy for Two, Healthy for You
    Arm Type
    Experimental
    Arm Description
    Remotely delivered behavioral health coaching in pregnancy and postpartum
    Arm Title
    Pregnancy Health Education
    Arm Type
    Active Comparator
    Arm Description
    Single health education visit with study staff member
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy for Two, Healthy for You
    Intervention Description
    Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health Education
    Other Intervention Name(s)
    Single health education visit
    Primary Outcome Measure Information:
    Title
    Gestational weight gain
    Description
    Gestational weight gain is calculated as weight, in pounds recorded at 37 weeks gestation minus the baseline weight recorded by 14 weeks gestation.
    Time Frame
    At 37 weeks gestation
    Secondary Outcome Measure Information:
    Title
    Postpartum weight retention
    Description
    Postpartum weight retention is calculated as weight, in pounds, recorded at 3 months after delivery minus the weight recorded at baseline (by 14 weeks gestation).
    Time Frame
    At 3 months after delivery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Pregnancy condition
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Mothers: BMI >= 18.5 kg/m2 at time of eligibility screening Age >=18 Able to provide informed consent 12 weeks gestation or earlier English speaking Insurance type Willing to provide address and >=2 contact people Consistent use of a personal smartphone and willingness to use for health behavior tracking as part of the study Patient at a participating prenatal clinical site Access to internet (including public library and smartphone) Demonstrated ability to track caloric intake for 4 days Singleton pregnancy Infants: • Born during Mother's enrollment in study Exclusion Criteria: • Type 1 or type 2 diabetes, pre-pregnancy or gestational diabetes, diagnosed prior to start of intervention (14 weeks gestation) Multiple fetuses Prior history of severe preeclampsia, pre-term birth (before 32 weeks gestation) Prior history of or current diagnosis of incompetent cervix Poorly controlled blood pressure (>160/100) Unable to walk 1 block without pain, shortness of breath Serious medication condition hindering use of recommendations for pregnancy weight gain Not cleared by study's maternal-fetal medicine or treating obstetrician Planning to relocate from areas in next 2 years Psychiatric or substance use related hospitalization in past 1 year (There is no exclusion criteria for the infants)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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