Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion (SPROUT)

June 1, 2023 updated by: University of Kansas Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Women in the usual care group, will received standard care from the obstetrician.
Experimental: High fiber
Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal weight and fat accretion changes
Time Frame: Baseline through 2-mounths postpartum
Assess weight and fat accretion change between groups using the Selinger four-compartment model
Baseline through 2-mounths postpartum
Identify changes in fiber intake and dietary quality
Time Frame: Baseline through 2-months postpartum
Compare fiber intake and dietary quality between groups by using 24-hour dietary recalls
Baseline through 2-months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant fat accrual
Time Frame: 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
Birth to 12-month old
Maternal weight and fat accretion
Time Frame: 2-months through 12-months postpartum
Assess weight and fat accretion change between groups using the Selinger four-compartment model
2-months through 12-months postpartum
Dietary fiber intake and dietary quality
Time Frame: 2-months through 12-months postpartum
Assess differences using the Alternative Healthy Eating Index (AHEI)
2-months through 12-months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Holly Hull, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2021

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00145397

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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