Trial Outcomes & Findings for A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy (NCT NCT04028843)

Last Updated: 2025-10-15

Results Overview

Number of pregnant women who gain appropriate weight during pregnancy as recommended by the Institute of Medicine Gestational Weight Gain guidelines

Recruitment status

COMPLETED

Study phase

Target enrollment

351 participants

Primary outcome timeframe

Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	172	179
Overall Study COMPLETED	135	137
Overall Study NOT COMPLETED	37	42

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	32	39
Overall Study Adverse Event	1	0
Overall Study Non-viable Pregnancy	0	1
Overall Study Withdrawal by Subject	4	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WIC Nutrition n=172 Participants 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 n=179 Participants 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.	Total n=351 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 6 • n=5 Participants	27 years STANDARD_DEVIATION 6 • n=7 Participants	27 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	172 Participants n=5 Participants	179 Participants n=7 Participants	351 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	95 Participants n=5 Participants	106 Participants n=7 Participants	201 Participants n=5 Participants
Race/Ethnicity, Customized Mixed or Other	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Population: 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).

Number of pregnant women who gain appropriate weight during pregnancy as recommended by the Institute of Medicine Gestational Weight Gain guidelines

Outcome measures

Outcome measures
Measure	WIC Nutrition n=126 Participants 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 n=139 Participants 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.
Number of Women Who Have Appropriate Gestational Weight Gain	21 Participants	24 Participants

SECONDARY outcome

Timeframe: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Measured weight from 10-16 weeks gestation to 35-38 weeks gestation

Outcome measures

Outcome measures
Measure	WIC Nutrition n=126 Participants 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 n=139 Participants 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.
Total Gestational Weight Gain	10.9 kilograms Interval 9.9 to 11.9	9.5 kilograms Interval 8.5 to 10.5

SECONDARY outcome

Timeframe: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Weight measured from 10-16 weeks gestation to 35-38 weeks gestation divided by the number of weeks between measures.

Outcome measures

Outcome measures
Measure	WIC Nutrition n=126 Participants 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 n=139 Participants 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.
Gestational Weight Gain Per Week	0.53 kilograms Interval 0.48 to 0.57	0.46 kilograms Interval 0.42 to 0.5

Adverse Events

WIC Nutrition

Serious events: 36 serious events

Other events: 110 other events

Deaths: 0 deaths

Healthy Beginnings

Serious events: 26 serious events

Other events: 134 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	WIC Nutrition n=172 participants at risk 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 n=179 participants at risk 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.
Blood and lymphatic system disorders Anemia	6.4% 11/172 • Number of events 11 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	13.4% 24/179 • Number of events 24 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
General disorders COVID-19	8.1% 14/172 • Number of events 14 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	10.1% 18/179 • Number of events 18 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Psychiatric disorders Depression	7.0% 12/172 • Number of events 12 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	8.9% 16/179 • Number of events 16 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Endocrine disorders Gestational diabetes	7.6% 13/172 • Number of events 13 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	7.3% 13/179 • Number of events 13 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Nervous system disorders Headache	11.6% 20/172 • Number of events 22 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	10.1% 18/179 • Number of events 20 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Gastrointestinal disorders Heartburn	9.9% 17/172 • Number of events 17 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	14.5% 26/179 • Number of events 26 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Vascular disorders Hypertension	8.7% 15/172 • Number of events 16 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	11.2% 20/179 • Number of events 23 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Blood and lymphatic system disorders Low iron	5.8% 10/172 • Number of events 11 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	7.8% 14/179 • Number of events 14 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Gastrointestinal disorders Nausea/vomiting	30.2% 52/172 • Number of events 54 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	38.5% 69/179 • Number of events 74 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Renal and urinary disorders Urinary tract infection	5.2% 9/172 • Number of events 9 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	5.0% 9/179 • Number of events 10 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Vaginal delivery pain	7.0% 12/172 • Number of events 12 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	6.1% 11/179 • Number of events 11 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)

Additional Information

Dr. Leanne Redman

Pennington Biomedical Research Center

Phone: 2257630947

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	WIC Nutrition n=172 participants at risk 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 n=179 participants at risk 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Musculoskeletal and connective tissue disorders Ankle fracture	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Gastrointestinal disorders Appendicitis	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign tumor	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Renal and urinary disorders Bladder puncture	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Vaginal Bleeding	1.2% 2/172 • Number of events 2 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	1.1% 2/179 • Number of events 2 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Injury, poisoning and procedural complications Blunt abdominal trauma	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain tumor	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
General disorders COVID-19	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Vascular disorders Dehydration	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Ear and labyrinth disorders Ear infection	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Eclampsia	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Cardiac disorders Elevated heart rate	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
General disorders Fever	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Infections and infestations Gallbladder infection	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Gastrointestinal disorders Gallstones	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	1.1% 2/179 • Number of events 2 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Nervous system disorders Headache	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	1.1% 2/179 • Number of events 2 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Vascular disorders Hematoma	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Vascular disorders Hypertension	3.5% 6/172 • Number of events 6 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	1.7% 3/179 • Number of events 3 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Metabolism and nutrition disorders Hypoglycemia	1.2% 2/172 • Number of events 2 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Incompetent cervix	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Infections and infestations Infection	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Renal and urinary disorders Kidney infection	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Skin and subcutaneous tissue disorders Leg lesion	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Low fetal activity	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Immune system disorders Steroid allergic reaction	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Respiratory, thoracic and mediastinal disorders Pneumonia	0.58% 1/172 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.00% 0/179 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	3.5% 6/172 • Number of events 6 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	3.9% 7/179 • Number of events 7 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Preterm contractions	4.7% 8/172 • Number of events 8 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	1.1% 2/179 • Number of events 2 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Preterm delivery	7.0% 12/172 • Number of events 12 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	3.4% 6/179 • Number of events 6 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/172 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)	0.56% 1/179 • Number of events 1 • Approximately 18 months (from 10-16th week of pregnancy until 12 month postpartum follow up)