Weight Gain During PregnancySmartMomsinWICNCT04028843

A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy

A study testing Healthy Beginnings in people with Weight Gain During Pregnancy, run by Pennington Biomedical Research 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

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Trial summary

The study will test the effectiveness of a smartphone-based behavior modification program adapted for use in Women, Infants, and Children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the Louisiana Women, Infants, and Children program. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Weight Gain During Pregnancy
What is being tested?: Healthy Beginnings
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 351 participants
Where: 1 siteUnited States
Study dates: 12 Jul 2019to 29 May 2025
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 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Less than 16 weeks gestational age at screening visit
Have a BMI of 18.5 to 40 kg/m2
Expecting a singleton pregnancy
Certified to receive Women, Infants, and Children services during current pregnancy
Has smartphone with internet access
Willing to be identifiable to other study participants in this study program

Who cannot join

Smoking
Drug or alcohol use
Non-pregnancy related illness
Hypertension at screening visit
Current mental health issue or eating disorder
Inability to complete a behavioral run-in task
Plans to move out of the state in the next 18 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: SmartMoms in WIC: A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy

Read the detailed description

The study is a multi-site randomized controlled trial, testing the effectiveness of the smartphone-based behavior modification program in pregnant women within the Louisiana Women, Infants, and Children program. Equal number of participants will be randomized to either the intervention or the control. Although the intervention itself lasts 24 weeks (only during pregnancy), women will be enrolled in this study for approximately 18 months, from the 10-16th week of pregnancy until 12 month postpartum follow-up. Study outcomes will be assessed at three visits during pregnancy (early, mid, and late,) and three visits postpartum (1, 6, and 12 months).

Conditions: Weight Gain During Pregnancy
Being tested: Healthy Beginnings

What participants receive

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

Healthy BeginningsBehavioural
The program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the smartphone application, personalized feedback from counselors and, evidence-based behavioral intervention delivered throughout pregnancy.

Study groups in NCT04028843
Study group	Role	What they receive
WIC Nutrition	No intervention	Participants will receive weight management advice and care through the standard Women, Infants, and Children program. They will also receive weekly health information related to pregnancy, birth, and infant health through a closed Facebook group.
Healthy Beginnings	Experimental	Participants will receive the SmartMoms smartphone application, a wireless connected scale, and a Fitbit. The Healthy Beginnings program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the SmartMoms smartphone application, personalized feedback from counselors, and evidence-based behavioral intervention delivered throughout pregnancy. Receives: Behavioral: Healthy Beginnings

What is being measured

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

Number of Women Who Have Appropriate Gestational Weight Gain
Number of pregnant women who gain appropriate weight during pregnancy as recommended by the Institute of Medicine Gestational Weight Gain guidelines
Measured: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Secondary outcomes (2)

Total Gestational Weight Gain
Measured weight from 10-16 weeks gestation to 35-38 weeks gestation
Measured: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Gestational Weight Gain Per Week
Weight measured from 10-16 weeks gestation to 35-38 weeks gestation divided by the number of weeks between measures.
Measured: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Timeline

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

12 Jul 201929 May 2025

First posted23 Jul 2019
Study start12 Jul 2019
Primary completion21 May 2024
Study completion29 May 2025

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 (6)Papers the sponsor has linked to this study.
Other trials for Weight Gain During PregnancyStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel assigned stratified by maternal BMI and site
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04028843
Sponsor's protocol ID: PBRC 2018-039
Other IDs: R01NR017644
Acronym: SmartMomsinWIC
Status last verified: Sep 2025
First submitted: 19 Jul 2019
Last updated: 15 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual data can be shared with appropriate material/data use agreements but there are no current plans.

Publications

Flanagan EW, Falkenhain K, Beyl RA, Altazan AD, Richard SA, Cabre HE, Kracht CL, Sparks JR, Kebbe M, Gilmore LA, Hsia DS, Apolzan JW, Redman LM. Gestational weight management in underserved mothers in the US. Am J Prev Med. 2026 Aug 8:108542. doi: 10.1016/j.amepre.2026.108542. Online ahead of print.
PubMed 42570779
Falkenhain K, Flanagan EW, Cabre HE, Kracht CL, Apolzan JW, Redman LM. Predictors of Redemption among Low-Income, Pregnant Women, Infants, and Children Participants: A Secondary Analysis of a Multicomponent eHealth Behavioral Intervention Study. J Nutr. 2026 Apr;156(4):101421. doi: 10.1016/j.tjnut.2026.101421. Epub 2026 Feb 17.
PubMed 41713843
Kracht CL, Falkenhain K, Flanagan EW, Altazan AD, Cabre HE, Kebbe M, Woolf EK, Beyl R, Hsia DS, Apolzan JW, Redman L. Effect of a Pragmatic eHealth Behavioral Gestational Weight Gain Intervention on Household Chaos in Pregnant People of Lower Socioeconomic Status: Randomized Controlled Trial. JMIR Ment Health. 2026 Jan 8;13:e74146. doi: 10.2196/74146.
PubMed 41505178
Cabre HE, Falkenhain K, Altazan AD, Flanagan EW, Kracht CL, Sparks JR, Kebbe M, Woolf EK, Hsia DS, Gilmore LA, Beyl R, Apolzan JW, Redman LM. Examining the Impact of a Codeveloped Multicomponent Mobile eHealth Lifestyle Intervention on Physical Activity and Its Association With Gestational Weight Gain in Underserved Women: A Statewide Randomized Controlled Trial. J Med Internet Res. 2025 Nov 11;27:e73962. doi: 10.2196/73962.
PubMed 41218199
Kebbe M, Falkenhain K, Beyl R, Altazan AD, Flanagan EW, Kracht CL, Cabre HE, Woolf EK, Hsia DS, Apolzan JW, Redman LM. An eHealth Intervention in Pregnancy on Maternal Body Composition and Subsequent Perinatal Outcomes: A Randomized Trial. Obesity (Silver Spring). 2025 Sep;33(9):1680-1693. doi: 10.1002/oby.24357. Epub 2025 Jul 24.
PubMed 40707419
Flanagan EW, Altazan AD, Comardelle NR, Gilmore LA, Apolzan JW, St Romain J, Hardee JC, Puyau RS, Mayet CL, Beyl RA, Barlow SA, Bounds SS, Olson KN, Kennedy BM, Hsia DS, Redman LM. The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial. JMIR Res Protoc. 2020 Sep 10;9(9):e18211. doi: 10.2196/18211.
PubMed 32909954

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

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All Weight Gain During Pregnancy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SmartMoms in WIC: A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy
ClinicalTrials.gov ID: NCT04028843
Acronym / sponsor ID: SmartMomsinWIC / PBRC 2018-039
Conditions: Weight Gain During Pregnancy
Study type: Interventional
Recruitment status: Completed
Enrolment: 351 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Collaborators: Louisiana Department of Health, National Institute of Nursing Research (NINR)
Study start: 12 Jul 2019 (actual)
Primary completion: 21 May 2024 (actual)
Study completion: 29 May 2025 (actual)
First posted: 23 Jul 2019 (actual)
Results: Posted 15 Oct 2025

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Parallel assigned stratified by maternal BMI and site

Arm	Type	Receives
WIC Nutrition	No intervention	–Participants will receive weight management advice and care through the standard Women, Infants, and Children program. They will also receive weekly health information related to pregnancy, birth, and infant health through a closed Facebook group.
Healthy Beginnings	Experimental	Behavioral: Healthy BeginningsParticipants will receive the SmartMoms smartphone application, a wireless connected scale, and a Fitbit. The Healthy Beginnings program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the SmartMoms smartphone application, personalized feedback from counselors, and evidence-based behavioral intervention delivered throughout pregnancy.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Less than 16 weeks gestational age at screening visit
Have a BMI of 18.5 to 40 kg/m2
Expecting a singleton pregnancy
Certified to receive Women, Infants, and Children services during current pregnancy
Has smartphone with internet access

Key exclusion criteria (7 listed)

Smoking
Drug or alcohol use
Non-pregnancy related illness
Hypertension at screening visit
Current mental health issue or eating disorder

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
Healthy BeginningsThe program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the smartphone application, personalized feedback from counselors and, evidence-based behavioral intervention delivered throughout pregnancy.	Behavioural	Healthy Beginnings

Primary outcome

Number of Women Who Have Appropriate Gestational Weight Gain
Time frame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Number of pregnant women who gain appropriate weight during pregnancy as recommended by the Institute of Medicine Gestational Weight Gain guidelines

2 secondary outcomes

Total Gestational Weight Gain
Time frame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Gestational Weight Gain Per Week
Time frame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Results and safety

Results posted to the registry on 15 Oct 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
WIC Nutrition	172	135
Healthy Beginnings	179	137

Primary outcome: Number of Women Who Have Appropriate Gestational Weight Gain

Time frame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation). Count of participants. Unit: Participants

Measure	WIC Nutrition n = 126	Healthy Beginnings n = 139
Value	21	24

Population analysed: 46 participants enrolled in WIC Nutrition were missing primary outcome measures and are not included in primary and secondary outcome analysis (23 missing follow up weights, 4 discontinued intervention, 19 lost to follow up). 40 participants enrolled in Healthy Beginnings were missing primary outcome measures and are not included in primary and secondary outcome analysis (21 missing follow up weights, 2 discontinued intervention, 17 lost to follow up).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WIC Nutrition	36 of 172 (20.9%)	110 of 172 (64%)	0 of 172
Healthy Beginnings	26 of 179 (14.5%)	134 of 179 (74.9%)	0 of 179

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42570779Flanagan EW, Falkenhain K, Beyl RA, Altazan AD, Richard SA, Cabre HE, Kracht CL, Sparks JR, Kebbe M, Gilmore LA, Hsia DS, Apolzan JW, Redman LM. Gestational weight management in underserved mothers in the US. Am J Prev Med. 2026 Aug 8:108542. doi: 10.1016/j.amepre.2026.108542. Online ahead of print.
Derived from this study: PubMed 41713843Falkenhain K, Flanagan EW, Cabre HE, Kracht CL, Apolzan JW, Redman LM. Predictors of Redemption among Low-Income, Pregnant Women, Infants, and Children Participants: A Secondary Analysis of a Multicomponent eHealth Behavioral Intervention Study. J Nutr. 2026 Apr;156(4):101421. doi: 10.1016/j.tjnut.2026.101421. Epub 2026 Feb 17.
Derived from this study: PubMed 41505178Kracht CL, Falkenhain K, Flanagan EW, Altazan AD, Cabre HE, Kebbe M, Woolf EK, Beyl R, Hsia DS, Apolzan JW, Redman L. Effect of a Pragmatic eHealth Behavioral Gestational Weight Gain Intervention on Household Chaos in Pregnant People of Lower Socioeconomic Status: Randomized Controlled Trial. JMIR Ment Health. 2026 Jan 8;13:e74146. doi: 10.2196/74146.
Derived from this study: PubMed 41218199Cabre HE, Falkenhain K, Altazan AD, Flanagan EW, Kracht CL, Sparks JR, Kebbe M, Woolf EK, Hsia DS, Gilmore LA, Beyl R, Apolzan JW, Redman LM. Examining the Impact of a Codeveloped Multicomponent Mobile eHealth Lifestyle Intervention on Physical Activity and Its Association With Gestational Weight Gain in Underserved Women: A Statewide Randomized Controlled Trial. J Med Internet Res. 2025 Nov 11;27:e73962. doi: 10.2196/73962.
Derived from this study: PubMed 40707419Kebbe M, Falkenhain K, Beyl R, Altazan AD, Flanagan EW, Kracht CL, Cabre HE, Woolf EK, Hsia DS, Apolzan JW, Redman LM. An eHealth Intervention in Pregnancy on Maternal Body Composition and Subsequent Perinatal Outcomes: A Randomized Trial. Obesity (Silver Spring). 2025 Sep;33(9):1680-1693. doi: 10.1002/oby.24357. Epub 2025 Jul 24.
Derived from this study: PubMed 32909954Flanagan EW, Altazan AD, Comardelle NR, Gilmore LA, Apolzan JW, St Romain J, Hardee JC, Puyau RS, Mayet CL, Beyl RA, Barlow SA, Bounds SS, Olson KN, Kennedy BM, Hsia DS, Redman LM. The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial. JMIR Res Protoc. 2020 Sep 10;9(9):e18211. doi: 10.2196/18211.
Individual participant dataSharing planned: No. Individual data can be shared with appropriate material/data use agreements but there are no current plans.

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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.

Leanne M Redman, Ph.D. principal investigator

Pennington Biomedical Research 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 Healthy Beginnings in people with Weight Gain During Pregnancy, run by Pennington Biomedical Research 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 6 inclusion and 7 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 15 Oct 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 15 Oct 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?

Number of Women Who Have Appropriate Gestational Weight Gain (time frame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)). 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 NCT04028843, which also lists 6 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 15 Oct 2025.