Clinical trial NCT04028843: A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy
Official title: SmartMoms in WIC: A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain During Pregnancy
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Louisiana Department of Health
First posted: 2019-07-23
Enrollment: 351
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assigned stratified by maternal BMI and site
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Women Who Have Appropriate Gestational Weight Gain
timeFrame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Secondary outcomes:
measure: Total Gestational Weight Gain
timeFrame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
measure: Gestational Weight Gain Per Week
timeFrame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.