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OpenTrials
Completed

NCT Number: NCT04868110

Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion

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.

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Key information

Conditions

Gestational Weight Gain Body Weight Body Weight Changes Infant Fat Accretion Maternal Fat Accretion Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Maternal Weight Changes

    Time frame: Baseline through 2-mounths postpartum

    Assess weight change between groups

  2. Maternal Fat Accretion Changes

    Time frame: Baseline through 2-mounths postpartum

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

  3. Identify Changes in Fiber Intake

    Time frame: Baseline through 2-months postpartum

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

  4. Identify Changes in Dietary Quality

    Time frame: 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 outcomes

  1. 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

  2. Maternal Weight

    Time frame: 2-months through 12-months postpartum

    Assess weight change

  3. Maternal Fat Accretion

    Time frame: 2-months through 12-months postpartum

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

  4. Dietary Fiber Intake

    Time frame: 2-months through 12-months postpartum

    Assess differences using 24h recalls

  5. Dietary Quality

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: SPROUT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2021
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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