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Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE) (GIRAFE)

Primary Purpose

Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary Fiber Intervention
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 Dietary Fiber, Gestational weight gain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women between 9 to 15 weeks pregnant
  • BMI between 22.0 - 40.0 kg/m2 and between the
  • Ages of 18-45 years
  • Able to be recruited from the University of Kansas Medical Center (KUMC).

Exclusion Criteria:

  • No Internet access
  • Consuming more than 20 grams per day of fiber
  • And/or with the following medical conditions during pregnancy:
  • Pre-gestational diabetes
  • Diagnosed with diabetes
  • Pre-eclampsia
  • Hypertension
  • Other metabolic abnormalities
  • Asthma
  • Heart disease
  • Smoking
  • Drug abuse
  • Pregnancies of multiples

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Arm

    Intervention Arm

    Arm Description

    Participants were informed to continue to receive usual care by their Obstetrician and were asked to send in body weights weekly.

    Received snacks high in fiber, attended weekly phone calls, recorded daily food intake and reported weekly body weight for 12 weeks.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Total gestational weight gain
    Measure gestational weight gain (kg) for those women in the intervention arm and control arm.
    Total dietary fiber intake
    ≥30 g/day

    Full Information

    First Posted
    June 10, 2019
    Last Updated
    June 13, 2019
    Sponsor
    University of Kansas Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03984630
    Brief Title
    Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)
    Acronym
    GIRAFE
    Official Title
    Feasibility of a Single Goal Intervention to Promote Appropriate Gestational Weight Gain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 11, 2016 (Actual)
    Primary Completion Date
    February 9, 2017 (Actual)
    Study Completion Date
    April 20, 2017 (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 study is to learn if consuming ≥30 grams or more of fiber per day can help pregnant women gain an appropriate amount of weight during their pregnancy.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Arm Description
    Participants were informed to continue to receive usual care by their Obstetrician and were asked to send in body weights weekly.
    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    Received snacks high in fiber, attended weekly phone calls, recorded daily food intake and reported weekly body weight for 12 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dietary Fiber Intervention
    Intervention Description
    Intervention included weekly group-based phone counseling with a Registered Dietitian (RD) to encourage consumption of a high fiber diet (≥30 g/day). All women reported their body weight weekly.
    Primary Outcome Measure Information:
    Title
    Proportion of excessive gestational weight gain based on weight gain guidelines.
    Time Frame
    12-24 weeks gestation and during pregnancy
    Secondary Outcome Measure Information:
    Title
    Total gestational weight gain
    Description
    Measure gestational weight gain (kg) for those women in the intervention arm and control arm.
    Time Frame
    12-24 weeks gestation and during pregnancy
    Title
    Total dietary fiber intake
    Description
    ≥30 g/day
    Time Frame
    12-24 weeks gestation and during pregnancy

    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: Women between 9 to 15 weeks pregnant BMI between 22.0 - 40.0 kg/m2 and between the Ages of 18-45 years Able to be recruited from the University of Kansas Medical Center (KUMC). Exclusion Criteria: No Internet access Consuming more than 20 grams per day of fiber And/or with the following medical conditions during pregnancy: Pre-gestational diabetes Diagnosed with diabetes Pre-eclampsia Hypertension Other metabolic abnormalities Asthma Heart disease Smoking Drug abuse Pregnancies of multiples
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Holly Hull, PhD
    Organizational Affiliation
    The University of Kansas Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32448177
    Citation
    Hull HR, Herman A, Gibbs H, Gajewski B, Krase K, Carlson SE, Sullivan DK, Goetz J. The effect of high dietary fiber intake on gestational weight gain, fat accrual, and postpartum weight retention: a randomized clinical trial. BMC Pregnancy Childbirth. 2020 May 24;20(1):319. doi: 10.1186/s12884-020-03016-5.
    Results Reference
    derived

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    Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)

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