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High Fiber Diet for Pregnancy Weight Gain (SPROUT Trial)

N/A

Waitlist Available

Led By Holly Hull, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-months through 12-months postpartum

Awards & highlights

SPROUT Trial Summary

This trial will see if a high fiber diet can help reduce weight gain during pregnancy and after birth.

Eligible Conditions

Pregnancy Weight Gain
Gestational Weight Gain
Maternal Weight Gain
Infant Weight Gain

SPROUT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-months through 12-months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-months through 12-months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-months through 12-months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Identify changes in fiber intake and dietary quality

Maternal weight and fat accretion changes

Secondary outcome measures

Dietary fiber intake and dietary quality

Infant fat accrual

Maternal weight and fat accretion

SPROUT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High fiberExperimental Treatment1 Intervention

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

Group II: Usual CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High fiber diet

2011

Completed Phase 2

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

461 Previous Clinical Trials

169,101 Total Patients Enrolled

Holly Hull, PhDPrincipal InvestigatorUniversity of Kansas Medical Center

3 Previous Clinical Trials

325 Total Patients Enrolled

Media Library

High fiber diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04868110 — N/A

Pregnancy Weight Gain Research Study Groups: Usual Care, High fiber

Pregnancy Weight Gain Clinical Trial 2023: High fiber diet Highlights & Side Effects. Trial Name: NCT04868110 — N/A

High fiber diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04868110 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to elderly individuals aged 75 and over?

"As per the trial's regulations, individuals aged 18 to 45 are eligible for this study. Additionally, there are 47 studies open to those under age 18 and 97 dedicated to patients 65 years old or older."

Answered by AI

Who fulfills the eligibility criteria for this clinical investigation?

"This clinical trial requires 56 individuals between 18 and 45 years old with a pre-pregnancy BMI range of 18.5 to 45.0 kg/m2 for gestational weight gain research."

Answered by AI

What is the principal objective of this experiment?

"As part of this trial, the primary objective is to monitor participants' fibre intake and dietary quality over a pre-intervention period and after one year. Secondary endpoints include analysing changes in gut microbiome composition and diversity through 16S V4 sequencing, comparing breast milk composition with mild infrared spectroscopy, as well as tracking metabolic markers, inflammatory factors, and brain health indices by way of blood samples analysed via the NIH Toolbox."

Answered by AI

Are there vacancies available for participants in this research endeavor?

"This clinical trial, posted on June 28th 2021 and last updated November 15th 2022, is not currently enlisting participants. However there are 182 other medical trials that remain actively recruiting patients at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion

2021. "Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04868110.

All > Weight Gain