Back to resultsPregnancy 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
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Dietary Fiber, Gestational weight gain
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
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
NCT ID
NCT03984630
First Posted
June 10, 2019
Last Updated
June 13, 2019
Sponsor
University of Kansas Medical Center
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
Learn more about this trial
Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)
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