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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03984630
Recruitment Status : Completed
First Posted : June 13, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Pregnancy Behavioral: Dietary Fiber Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of a Single Goal Intervention to Promote Appropriate Gestational Weight Gain
Actual Study Start Date : August 11, 2016
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Arm
Participants were informed to continue to receive usual care by their Obstetrician and were asked to send in body weights weekly.
Experimental: Intervention Arm
Received snacks high in fiber, attended weekly phone calls, recorded daily food intake and reported weekly body weight for 12 weeks.
Behavioral: Dietary Fiber Intervention
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 Measures :
  1. Proportion of excessive gestational weight gain based on weight gain guidelines. [ Time Frame: 12-24 weeks gestation and during pregnancy ]

Secondary Outcome Measures :
  1. Total gestational weight gain [ Time Frame: 12-24 weeks gestation and during pregnancy ]
    Measure gestational weight gain (kg) for those women in the intervention arm and control arm.

  2. Total dietary fiber intake [ Time Frame: 12-24 weeks gestation and during pregnancy ]
    ≥30 g/day



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984630


Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Holly Hull, PhD The University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03984630     History of Changes
Other Study ID Numbers: STUDY0004032
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
Dietary Fiber
Gestational weight gain

Additional relevant MeSH terms:
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Gestational Weight Gain
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms