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Promoting Appropriate Weight Gain Pregnant Women (GRUVE)

Primary Purpose

Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention
Intervention 2
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Gestational weight gain, Physical activity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 12-16 weeks pregnant
  • Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2

Exclusion Criteria:

  • Diabetes
  • Pre-eclampsia
  • Hypertension
  • Other metabolic abnormalities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control Arm

    Intervention Arm

    Intervention Arm 2

    Arm Description

    Participants in this group were informed to continue to receive usual care.

    Received an interactive physical activity monitoring system (the Gruve®).

    Received an interactive physical activity monitoring system (the Gruve®) and group based phone counseling (GBPC).

    Outcomes

    Primary Outcome Measures

    Excessive gestational weight gain
    Proportion of excessive gestational weight gain based on weight gain guidelines.

    Secondary Outcome Measures

    Gestational weight gain
    Total weight change during pregnancy
    Infant fat mass
    Infant fat mass

    Full Information

    First Posted
    November 14, 2019
    Last Updated
    November 25, 2019
    Sponsor
    University of Kansas Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04180878
    Brief Title
    Promoting Appropriate Weight Gain Pregnant Women
    Acronym
    GRUVE
    Official Title
    Promoting Appropriate Weight Gain Pregnant Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 26, 2013 (Actual)
    Primary Completion Date
    December 16, 2015 (Actual)
    Study Completion Date
    February 3, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Kansas Medical 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
    The purpose of this study is to learn if engaging in group based phone counseling (GBPC) and an interactive physical activity monitoring system can help pregnant women gain an appropriate amount of weight during pregnancy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy
    Keywords
    Gestational weight gain, Physical activity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Arm Description
    Participants in this group were informed to continue to receive usual care.
    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    Received an interactive physical activity monitoring system (the Gruve®).
    Arm Title
    Intervention Arm 2
    Arm Type
    Experimental
    Arm Description
    Received an interactive physical activity monitoring system (the Gruve®) and group based phone counseling (GBPC).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intervention
    Intervention Description
    Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intervention 2
    Intervention Description
    Participants received an interactive physical activity monitoring system, an electronic scale to report weekly body weight, weekly hour long conference calls with structured interactive educational lessons led by Health Educator, dietary recalls were completed at three different time points during their participation, and study personnel monitored physical activity levels weekly.
    Primary Outcome Measure Information:
    Title
    Excessive gestational weight gain
    Description
    Proportion of excessive gestational weight gain based on weight gain guidelines.
    Time Frame
    During Pregnancy - 18-36 week gestational age
    Secondary Outcome Measure Information:
    Title
    Gestational weight gain
    Description
    Total weight change during pregnancy
    Time Frame
    During Pregnancy - 18-36 week gestational age
    Title
    Infant fat mass
    Description
    Infant fat mass
    Time Frame
    1-4 days after birth

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 12-16 weeks pregnant Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2 Exclusion Criteria: Diabetes Pre-eclampsia Hypertension Other metabolic abnormalities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Holly R Hull, PhD
    Organizational Affiliation
    The University of Kansas Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Promoting Appropriate Weight Gain Pregnant Women

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