Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)

University of Kansas

Status: Completed

Conditions: Pregnancy

Treatments: Behavioral: Dietary Fiber Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03984630

STUDY0004032

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Participants were informed to continue to receive usual care by their Obstetrician and were asked to send in body weights weekly.

Intervention Arm

Experimental group

Description:

Received snacks high in fiber, attended weekly phone calls, recorded daily food intake and reported weekly body weight for 12 weeks.

Treatment:

Behavioral: Dietary Fiber Intervention