Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)

Pregnancy Clinical Trial

— GIRAFE  

Official title:

Feasibility of a Single Goal Intervention to Promote Appropriate Gestational Weight Gain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984630
• Other study ID #: STUDY0004032
• Status: Completed
• Phase: N/A
• Start date: August 11, 2016
• Est. completion date: April 20, 2017

Study information

• Verified date: June 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 20, 2017
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of excessive gestational weight gain based on weight gain guidelines.		12-24 weeks gestation and during pregnancy
Secondary	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
Secondary	Total dietary fiber intake	=30 g/day	12-24 weeks gestation and during pregnancy