Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)

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.

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Key information

Conditions

Pregnancy Body Weight Body Weight Changes Gestational Weight Gain Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Fiber Intervention

Behavioral

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 outcomes

Proportion of excessive gestational weight gain based on weight gain guidelines.

Time frame: 12-24 weeks gestation and during pregnancy

Secondary outcomes

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.
Total dietary fiber intake

Time frame: 12-24 weeks gestation and during pregnancy

≥30 g/day

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: GIRAFE

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 13, 2019
Registry last updated: Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed