Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion

Gestational Weight Gain Clinical Trial

— SPROUT  

Official title:

Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion by Increasing Fiber Intake and Changing the Maternal Microbiome During Pregnancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04868110
• Other study ID #: STUDY00145397
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn if consuming a high fiber diet will reduce gestational weight gain and maternal and infant fat accretion.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pre-pregnancy BMI 18.5 - 45.0 kg/m2

Exclusion Criteria:

• Comsuming more than 20 g/day of fiber

• No phone and internet access

• Pre-gestational diabetes

• Diagnosed with diabetes

• Pre-eclampsia

• Hypertension

• Other metabolic abnormalities

• Asthma

• Heart disease

• Smoking

• Drug abuse

• Recent antibiotic use

• Pregnancies of multiples

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Weight Gain

Intervention

Behavioral:
• High fiber diet
A registered dietitian will delivered the lessons on consuming a high fiber diet to small groups to increased engage and material retention. These lessons will last 18 weeks.

Locations

Country	Name	City	State
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal weight and fat accretion changes	Assess weight and fat accretion change between groups using the Selinger four-compartment model	Baseline through 2-mounths postpartum
Primary	Identify changes in fiber intake and dietary quality	Compare fiber intake and dietary quality between groups by using 24-hour dietary recalls	Baseline through 2-months postpartum
Secondary	Infant fat accrual	Identify differences in early infant fat accrual between group by completing body composition measurements including but not limited to Dual energy x-ray absorptiometry (DXA) and PeaPod	Birth to 12-month old
Secondary	Maternal weight and fat accretion	Assess weight and fat accretion change between groups using the Selinger four-compartment model	2-months through 12-months postpartum
Secondary	Dietary fiber intake and dietary quality	Assess differences using the Alternative Healthy Eating Index (AHEI)	2-months through 12-months postpartum