Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)
GIRAFE
Feasibility of a Single Goal Intervention to Promote Appropriate Gestational Weight Gain
1 other identifier
interventional
25
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pregnancy
Started Aug 2016
Shorter than P25 for not_applicable pregnancy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedFirst Submitted
Initial submission to the registry
June 10, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedAugust 2, 2024
July 1, 2024
6 months
June 10, 2019
July 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of excessive gestational weight gain based on weight gain guidelines.
12-24 weeks gestation and during pregnancy
Secondary Outcomes (2)
Total gestational weight gain
12-24 weeks gestation and during pregnancy
Total dietary fiber intake
12-24 weeks gestation and during pregnancy
Study Arms (2)
Control Arm
NO INTERVENTIONParticipants were informed to continue to receive usual care by their Obstetrician and were asked to send in body weights weekly.
Intervention Arm
EXPERIMENTALReceived snacks high in fiber, attended weekly phone calls, recorded daily food intake and reported weekly body weight for 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32448177DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly Hull, PhD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2019
First Posted
June 13, 2019
Study Start
August 11, 2016
Primary Completion
February 9, 2017
Study Completion
April 20, 2017
Last Updated
August 2, 2024
Record last verified: 2024-07