PregnancyGIRAFENCT03984630
Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)
A study testing Dietary Fiber Intervention in people with Pregnancy, run by University of Kansas Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Dietary Fiber Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2016to 20 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
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- Hypertension
- Other metabolic abnormalities
- Asthma
- Heart disease
- Smoking
- Drug abuse
- Pregnancies of multiples
About this study
Official title: Feasibility of a Single Goal Intervention to Promote Appropriate Gestational Weight Gain
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.
- Conditions
- Pregnancy
- Being tested
- Dietary Fiber Intervention
- Keywords
- Dietary Fiber, Gestational weight gain
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Fiber InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Participants were informed to continue to receive usual care by their Obstetrician and were asked to send in body weights weekly. |
| Intervention Arm | Experimental | Received snacks high in fiber, attended weekly phone calls, recorded daily food intake and reported weekly body weight for 12 weeks. Receives: Behavioral: Dietary Fiber Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of excessive gestational weight gain based on weight gain guidelines.
Measured: 12-24 weeks gestation and during pregnancy
Secondary outcomes (2)
Total gestational weight gain
Measure gestational weight gain (kg) for those women in the intervention arm and control arm.
Measured: 12-24 weeks gestation and during pregnancy
Total dietary fiber intake
≥30 g/day
Measured: 12-24 weeks gestation and during pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start11 Aug 2016
- Primary completion9 Feb 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Hull, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984630
- Sponsor's protocol ID
- STUDY0004032
- Acronym
- GIRAFE
- Status last verified
- Jul 2024
- First submitted
- 10 Jun 2019
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32448177
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Single Goal Intervention to Promote Appropriate Gestational Weight Gain
- ClinicalTrials.gov ID
- NCT03984630
- Acronym / sponsor ID
- GIRAFE / STUDY0004032
- Conditions
- Pregnancy
- Keywords
- Dietary Fiber, Gestational weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Participants were informed to continue to receive usual care by their Obstetrician and were asked to send in body weights weekly. |
| Intervention Arm | Experimental | Behavioral: Dietary Fiber InterventionReceived snacks high in fiber, attended weekly phone calls, recorded daily food intake and reported weekly body weight for 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Fiber InterventionIntervention 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. | Behavioural | Intervention Arm |
Primary outcome
Proportion of excessive gestational weight gain based on weight gain guidelines.
Time frame: 12-24 weeks gestation and during pregnancy
2 secondary outcomes
Total gestational weight gain
Time frame: 12-24 weeks gestation and during pregnancy
Total dietary fiber intake
Time frame: 12-24 weeks gestation and during pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 32448177Hull 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Hull, PhD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fiber Intervention in people with Pregnancy, run by University of Kansas Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of excessive gestational weight gain based on weight gain guidelines. (time frame: 12-24 weeks gestation and during pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03984630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.