Gestational Weight GainSPROUTNCT04868110

Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion

A study testing High fiber diet in people with Gestational Weight Gain and Maternal Fat Accretion, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Gestational Weight Gain, Maternal Fat Accretion, Infant Fat Accretion
What is being tested?: High fiber diet
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 28 Jun 2021to 12 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Pre-pregnancy BMI 18.5 - 45.0 kg/m2

Who cannot join

Comsuming more than 20 g/day of fiber
No phone and internet access
Pre-gestational diabetes
Diagnosed with diabetes
Pre-eclampsia
Hypertension

Show all 13Show fewer

Other metabolic abnormalities
Asthma
Heart disease
Smoking
Drug abuse
Recent antibiotic use
Pregnancies of multiples

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: 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.

Conditions: Gestational Weight Gain, Maternal Fat Accretion, Infant Fat Accretion
Being tested: High fiber diet
Keywords: Fat mass, Gestational weight gain, Infant fat mass, High fiber, Microbiome
Medical subject headings: Gestational Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High fiber dietBehavioural
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.

Study groups in NCT04868110
Study group	Role	What they receive
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. Receives: Behavioral: High fiber diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Maternal Weight Changes
Assess weight change between groups
Measured: Baseline through 2-mounths postpartum
Maternal Fat Accretion Changes
Assess fat accretion change between groups using the Selinger four-compartment model
Measured: Baseline through 2-mounths postpartum
Identify Changes in Fiber Intake
Compare fiber intake between groups by using 24-hour dietary recalls
Measured: 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).
Measured: Baseline through 2-months postpartum

Secondary outcomes (5)

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
Measured: Birth to 12-month old
Maternal Weight
Assess weight change
Measured: 2-months through 12-months postpartum
Maternal Fat Accretion
Assess fat accretion change between groups using the Selinger four-compartment model
Measured: 2-months through 12-months postpartum
Dietary Fiber Intake
Assess differences using 24h recalls
Measured: 2-months through 12-months postpartum
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).
Measured: 2-months through 12-months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 202112 Oct 2023

First posted30 Apr 2021
Study start28 Jun 2021
Primary completion29 Sep 2023
Study completion12 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gestational Weight GainStudies of the same condition, open and under way.
More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04868110
Sponsor's protocol ID: STUDY00145397
Acronym: SPROUT
Status last verified: Dec 2024
First submitted: 14 Apr 2021
Last updated: 27 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Herman A, Hand LK, Koestler DC, Krase KE, Taylor MK, Sullivan DK, Goetz JR, Hull HR. A diet emphasizing high-fiber foods during pregnancy decreases gestational weight gain and fat accrual: results from a pilot trial. Nutr Res. 2026 Sep 6;155:35-47. doi: 10.1016/j.nutres.2026.09.001. Online ahead of print.
PubMed 42815196
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.
PubMed 38145714

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingObservational study
Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
Bariatric Surgery, Pregnency
Active, not recruiting
Time-restricted Eating Among Pregnant Females With Severe Obesity
Obesity, Morbid, Time Restricted Eating
Recruiting
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain

All Gestational Weight Gain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion by Increasing Fiber Intake and Changing the Maternal Microbiome During Pregnancy
ClinicalTrials.gov ID: NCT04868110
Acronym / sponsor ID: SPROUT / STUDY00145397
Conditions: Gestational Weight Gain, Maternal Fat Accretion, Infant Fat Accretion
Keywords: Fat mass, Gestational weight gain, Infant fat mass, High fiber, Microbiome
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Study start: 28 Jun 2021 (actual)
Primary completion: 29 Sep 2023 (actual)
Study completion: 12 Oct 2023 (actual)
First posted: 30 Apr 2021 (actual)
Results: Posted 27 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Usual Care	No intervention	–Women in the usual care group, will received standard care from the obstetrician.
High fiber	Experimental	Behavioral: High fiber dietWomen in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Pre-pregnancy BMI 18.5 - 45.0 kg/m2

Key exclusion criteria (13 listed)

Comsuming more than 20 g/day of fiber
No phone and internet access
Pre-gestational diabetes
Diagnosed with diabetes
Pre-eclampsia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High fiber dietA 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.	Behavioural	High fiber

Primary outcome

Maternal Weight Changes
Time frame: Baseline through 2-mounths postpartum
Assess weight change between groups
Maternal Fat Accretion Changes
Time frame: Baseline through 2-mounths postpartum
Assess fat accretion change between groups using the Selinger four-compartment model
Identify Changes in Fiber Intake
Time frame: Baseline through 2-months postpartum
Compare fiber intake between groups by using 24-hour dietary recalls
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).

5 secondary outcomes

Infant Fat Accrual
Time frame: Birth to 12-month old
Maternal Weight
Time frame: 2-months through 12-months postpartum
Maternal Fat Accretion
Time frame: 2-months through 12-months postpartum
Dietary Fiber Intake
Time frame: 2-months through 12-months postpartum
Dietary Quality
Time frame: 2-months through 12-months postpartum

Results and safety

Results posted to the registry on 27 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	26	23
High Fiber	25	21

Primary outcome: Maternal Weight Changes

Time frame: Baseline through 2-mounths postpartum. Mean (Standard Deviation). Unit: kg

Measure	Usual Care n = 15	High Fiber n = 16
Weight at Baseline (kg)	70.20 (10.44)	66.47 (7.04)
Weight at End of Pregnancy (kg)	80.12 (10.00)	75.80 (6.89)
Weight at 2mo postpartum (kg)	73.53 (10.04)	67.99 (7.36)

Population analysed: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.

Primary outcome: Maternal Fat Accretion Changes

Time frame: Baseline through 2-mounths postpartum. Mean (Standard Deviation). Unit: percent fat mass

Measure	Usual Care n = 15	High Fiber n = 16
Percent Fat Mass at Baseline	33.49 (5.96)	32.27 (5.18)
Percent Fat Mass at End of Pregnancy	36.74 (5.05)	34.91 (4.33)
Percent Fat Mass at 2mo postpartum	36.35 (5.95)	34.38 (5.65)

Population analysed: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.

Primary outcome: Identify Changes in Fiber Intake

Time frame: Baseline through 2-months postpartum. Mean (Standard Deviation). Unit: g/day

Measure	Usual Care n = 15	High Fiber n = 16
Total Dietary Fiber Intake at Baseline (g/day)	19.01 (3.88)	21.84 (7.51)
Total Dietary Fiber Intake at End of Pregnancy (g/day)	19.35 (8.05)	35.09 (7.37)
Total Dietary Fiber Intake at 2mo postpartum (g/day)	19.62 (6.78)	29.71 (10.63)

Population analysed: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.

Primary outcome: Identify Changes in Dietary Quality

Time frame: Baseline through 2-months postpartum. Mean (Standard Deviation). Unit: AHEI score

Measure	Usual Care n = 15	High Fiber n = 16
Alternative Healthy Eating Index (AHEI) Total Score at Baseline	54.59 (9.82)	62.51 (10.95)
Alternative Healthy Eating Index (AHEI) Total Score at End of Pregnancy	50.06 (11.34)	70.12 (12.41)
Alternative Healthy Eating Index (AHEI) Total Score at 2mo postpartum	51.43 (10.34)	62.53 (9.33)

Population analysed: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was tracked and monitored from baseline (12-20 weeks gestation) until 30 days post invention (up to 2 weeks postpartum).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 24 (0%)	0 of 24 (0%)	0 of 24
High Fiber	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42815196Herman A, Hand LK, Koestler DC, Krase KE, Taylor MK, Sullivan DK, Goetz JR, Hull HR. A diet emphasizing high-fiber foods during pregnancy decreases gestational weight gain and fat accrual: results from a pilot trial. Nutr Res. 2026 Sep 6;155:35-47. doi: 10.1016/j.nutres.2026.09.001. Online ahead of print.
Derived from this study: PubMed 38145714Herman 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.

Related trials for Gestational Weight Gain

Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingObservational study
Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
Bariatric Surgery, Pregnency
Active, not recruiting
Time-restricted Eating Among Pregnant Females With Severe Obesity
Obesity, Morbid, Time Restricted Eating
Recruiting
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly Hull, PhD principal investigator

University of Kansas Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High fiber diet in people with Gestational Weight Gain and Maternal Fat Accretion, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Weight Changes (time frame: Baseline through 2-mounths postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04868110, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.