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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR017644 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Louisiana Department of Health | UNKNOWN |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Beginnings | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Gestational Weight Gain | Measured weight from 10-16 weeks gestation to 35-38 weeks gestation | Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) |
| Gestational Weight Gain Per Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanne M Redman, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41713843 | Derived | 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. | |
| 41505178 | Derived | 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. |
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Individual data can be shared with appropriate material/data use agreements but there are no current plans.
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| ID | Title | Description |
|---|---|---|
| FG000 | WIC Nutrition | 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. |
| FG001 | Healthy Beginnings | 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. Healthy Beginnings: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | WIC Nutrition | 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. |
| BG001 | Healthy Beginnings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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). | Posted | Count of Participants | Participants | Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) |
|
Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WIC Nutrition | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leanne Redman | Pennington Biomedical Research Center | 2257630947 | Leanne.Redman@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2024 | Dec 13, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2024 | Sep 26, 2025 | SAP_001.pdf |
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Parallel assigned stratified by maternal BMI and site
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Weight measured from 10-16 weeks gestation to 35-38 weeks gestation divided by the number of weeks between measures.
| Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) |
| 41218199 | Derived | 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. |
| 40707419 | Derived | 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. |
| 32909954 | Derived | 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. |
| Non-viable Pregnancy |
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| Withdrawal by Subject |
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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. Healthy Beginnings: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Healthy Beginnings | 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. Healthy Beginnings: 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. |
|
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| Secondary | Total Gestational Weight Gain | Measured weight from 10-16 weeks gestation to 35-38 weeks gestation | 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). | Posted | Mean | 95% Confidence Interval | kilograms | Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) |
|
|
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| Secondary | 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. | 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). | Posted | Mean | 95% Confidence Interval | kilograms | Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) |
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| 0 |
| 172 |
| 36 |
| 172 |
| 110 |
| 172 |
| EG001 | Healthy Beginnings | 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. Healthy Beginnings: 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. | 0 | 179 | 26 | 179 | 134 | 179 |
| Ankle fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Benign tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Bladder puncture | Renal and urinary disorders | Non-systematic Assessment |
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| Vaginal Bleeding | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Blunt abdominal trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Brain tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| COVID-19 | General disorders | Non-systematic Assessment |
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| Dehydration | Vascular disorders | Non-systematic Assessment |
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| Ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
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| Eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Elevated heart rate | Cardiac disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Gallbladder infection | Infections and infestations | Non-systematic Assessment |
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| Gallstones | Gastrointestinal disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Hematoma | Vascular disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Incompetent cervix | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Kidney infection | Renal and urinary disorders | Non-systematic Assessment |
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| Leg lesion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Low fetal activity | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Steroid allergic reaction | Immune system disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Preterm contractions | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Preterm delivery | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Stillbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| COVID-19 | General disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Gestational diabetes | Endocrine disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Low iron | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Vaginal delivery pain | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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