Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion

Not Applicable

Completed

• Conditions: Gestational Weight Gain; Infant Fat Accretion; Maternal Fat Accretion

• Registration Number: NCT04868110
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Study Start: 2021-06-28
• Primary Completion: 2023-09-29
• Study Completion: 2023-10-12
• Results First Submitted: 2024-05-30
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Results First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal Weight Changes	Baseline through 2-mounths postpartum	Assess weight change between groups
Maternal Fat Accretion Changes	Baseline through 2-mounths postpartum	Assess fat accretion change between groups using the Selinger four-compartment model
Identify Changes in Fiber Intake	Baseline through 2-months postpartum	Compare fiber intake between groups by using 24-hour dietary recalls
Identify Changes in Dietary Quality	Baseline through 2-months postpartum	Compare dietary quality between groups using the Alternative Healthy Eating Index (AHEI) scoring ranges from 0 to 100 (higher score means a better diet quality).

Secondary Outcome Measures

Name	Time	Method
Maternal Weight	2-months through 12-months postpartum	Assess weight change
Infant Fat Accrual	Birth to 12-month old	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
Maternal Fat Accretion	2-months through 12-months postpartum	Assess fat accretion change between groups using the Selinger four-compartment model
Dietary Fiber Intake	2-months through 12-months postpartum	Assess differences using 24h recalls
Dietary Quality	2-months through 12-months postpartum	Compare dietary quality between groups using the Alternative Healthy Eating Index (AHEI) scoring ranges from 0 to 100 (higher score means a better diet quality).

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States