Weight Gain During Pregnancy
Conditions
Brief 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.
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).
Interventions
BEHAVIORALHealthy 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.
Sponsors
Louisiana Department of Health
National Institute of Nursing Research (NINR)
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Parallel assigned stratified by maternal BMI and site
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Who Have Appropriate Gestational Weight Gain | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Gestational Weight Gain | 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 |
| Gestational Weight Gain Per Week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 172 |
| 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. | 179 |
| Total | 351 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 32 | 39 |
| Overall Study | Non-viable Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | WIC Nutrition | Healthy Beginnings | Total |
|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 6 | 27 years STANDARD_DEVIATION 6 | 27 years STANDARD_DEVIATION 6 |
| Race/Ethnicity, Customized Hispanic | 13 Participants | 10 Participants | 23 Participants |
| Race/Ethnicity, Customized Mixed or Other | 10 Participants | 8 Participants | 18 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 95 Participants | 106 Participants | 201 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 54 Participants | 55 Participants | 109 Participants |
| Sex: Female, Male Female | 172 Participants | 179 Participants | 351 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 172 | 0 / 179 |
| other Total, other adverse events | 110 / 172 | 134 / 179 |
| serious Total, serious adverse events | 36 / 172 | 26 / 179 |
Outcome results
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
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WIC Nutrition | Number of Women Who Have Appropriate Gestational Weight Gain | 21 Participants |
| Healthy Beginnings | Number of Women Who Have Appropriate Gestational Weight Gain | 24 Participants |
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| WIC Nutrition | Gestational Weight Gain Per Week | 0.53 kilograms |
| Healthy Beginnings | Gestational Weight Gain Per Week | 0.46 kilograms |
Secondary
Total Gestational Weight Gain
Measured weight from 10-16 weeks gestation to 35-38 weeks gestation
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| WIC Nutrition | Total Gestational Weight Gain | 10.9 kilograms |
| Healthy Beginnings | Total Gestational Weight Gain | 9.5 kilograms |