Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion

NCT04868110 | Completed Results

• 1 other identifier: STUDY00145397
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Weight Gain; Maternal Fat Accretion; Infant Fat Accretion

Keywords

Fat mass; Gestational weight gain; Infant fat mass; High fiber; Microbiome

Outcome Measures

Primary Outcomes (4)

• Maternal Weight Changes

  Assess weight change between groups

  Baseline through 2-mounths postpartum

• Maternal Fat Accretion Changes

  Assess fat accretion change between groups using the Selinger four-compartment model

  Baseline through 2-mounths postpartum

• Identify Changes in Fiber Intake

  Compare fiber intake between groups by using 24-hour dietary recalls

  Baseline through 2-months postpartum

• Identify Changes in Dietary Quality

  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).

  Baseline through 2-months postpartum

Secondary Outcomes (5)

• Infant Fat Accrual

  Birth to 12-month old

• Maternal Weight

  2-months through 12-months postpartum

• Maternal Fat Accretion

  2-months through 12-months postpartum

• Dietary Fiber Intake

  2-months through 12-months postpartum

• Dietary Quality

  2-months through 12-months postpartum

Study Arms (2)

Usual Care

NO INTERVENTION

Women in the usual care group, will received standard care from the obstetrician.

High fiber

EXPERIMENTAL

Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks.

Behavioral: High fiber diet

Interventions

High fiber diet BEHAVIORAL

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.

High fiber

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-pregnancy BMI 18.5 - 45.0 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• Herman A, Hand LK, Gajewski B, Krase K, Sullivan DK, Goetz J, Hull HR. A high fiber diet intervention during pregnancy: The SPROUT (Single goal in PRegnancy to optimize OUTcomes) protocol paper. Contemp Clin Trials. 2024 Feb;137:107420. doi: 10.1016/j.cct.2023.107420. Epub 2023 Dec 23.

  PMID: 38145714 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Holly Hull
• Organization: University of Kansas Medical Center

hhull@kumc.edu

9135881000

Study Officials

• Holly Hull, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women in the control group will participate in weekly lessons for 18 weeks on eating a high fiber diet and will received daily snacks.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 30, 2021
• Study Start: June 28, 2021
• Primary Completion: September 29, 2023
• Study Completion: October 12, 2023
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2024-12

Locations

US (1)