search
Back to results

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

Primary Purpose

Gestational Weight Gain, Maternal Fat Accretion, Infant Fat Accretion

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High fiber diet
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Weight Gain focused on measuring Fat mass, Gestational weight gain, Infant fat mass, High fiber, Microbiome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

High fiber

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maternal weight and fat accretion changes
Assess weight and fat accretion change between groups using the Selinger four-compartment model
Identify changes in fiber intake and dietary quality
Compare fiber intake and dietary quality between groups by using 24-hour dietary recalls

Secondary Outcome Measures

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
Maternal weight and fat accretion
Assess weight and fat accretion change between groups using the Selinger four-compartment model
Dietary fiber intake and dietary quality
Assess differences using the Alternative Healthy Eating Index (AHEI)

Full Information

First Posted
April 14, 2021
Last Updated
June 1, 2023
Sponsor
University of Kansas Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04868110
Brief Title
Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion
Acronym
SPROUT
Official Title
Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion by Increasing Fiber Intake and Changing the Maternal Microbiome During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain, Maternal Fat Accretion, Infant Fat Accretion
Keywords
Fat mass, Gestational weight gain, Infant fat mass, High fiber, Microbiome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Women in the control group will participate in weekly lessons for 18 weeks on eating a high fiber diet and will received daily snacks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Women in the usual care group, will received standard care from the obstetrician.
Arm Title
High fiber
Arm Type
Experimental
Arm Description
Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks.
Intervention Type
Behavioral
Intervention Name(s)
High fiber diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal weight and fat accretion changes
Description
Assess weight and fat accretion change between groups using the Selinger four-compartment model
Time Frame
Baseline through 2-mounths postpartum
Title
Identify changes in fiber intake and dietary quality
Description
Compare fiber intake and dietary quality between groups by using 24-hour dietary recalls
Time Frame
Baseline through 2-months postpartum
Secondary Outcome Measure Information:
Title
Infant fat accrual
Description
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
Time Frame
Birth to 12-month old
Title
Maternal weight and fat accretion
Description
Assess weight and fat accretion change between groups using the Selinger four-compartment model
Time Frame
2-months through 12-months postpartum
Title
Dietary fiber intake and dietary quality
Description
Assess differences using the Alternative Healthy Eating Index (AHEI)
Time Frame
2-months through 12-months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Hull, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion

We'll reach out to this number within 24 hrs