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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Dietary Fiber Intervention

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of excessive gestational weight gain based on weight gain guidelines.	12-24 weeks gestation and during pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total gestational weight gain	Measure gestational weight gain (kg) for those women in the intervention arm and control arm.	12-24 weeks gestation and during pregnancy
Total dietary fiber intake	≥30 g/day	12-24 weeks gestation and during pregnancy

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Holly Hull, PhD, The University of Kansas Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2016
• Primary Completion (Actual): February 9, 2017
• Study Completion (Actual): April 20, 2017

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Gestational weight gain; Dietary Fiber
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: STUDY0004032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No