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The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads.
Assess the feasibility and acceptability of a digital intervention aimed at increasing responsive infant feeding behaviors, beginning 1 month postpartum and continuing through 3-months postpartum, among a prospective cohort of women receiving WIC benefits.
Use qualitative methods to explore barriers and facilitators to participation in a digital infant feeding intervention among women receiving WIC benefits during early postpartum
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Health Intervention | Experimental | Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) tips to foster self-efficacy and skills training around responsive feeding - provide fully automated tailored feedback, which will include theory-driven content that aims to normalize common issues and problems, provide active solutions to feeding problems and affirm positive behavior. Participants will receive daily text messages for 12 weeks. Twice a week participants will be asked to self-monitor their adherence to goals in response to a text messaging prompt and will immediately receive tailored feedback and tips. |
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| Safety Control | Active Comparator | Participants will receive tips to foster self-efficacy and skills training around infant safety. Participants will receive daily text messages for 12 weeks. Twice a week participants will be asked to self-monitor their adherence to safety goals in response to a text messaging prompt and will immediately receive tailored feedback and tips. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health Intervention | Behavioral | Participants will receive: 1) behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. We will use text messaging to administer the intervention pieces. At baseline, each participant will complete a series of surveys to gain background information. Throughout the study participants will report their goal adherence in response to a text messaging prompt and immediately receive tailored feedback. Text messages will be deployed daily with 2 check in messages per week; participants will receive tailored feedback based on their response. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement - average text message completion rate | Engagement will be assessed by reporting the average text message completion rate over the 12-week intervention period. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Scores - Acceptability | Satisfaction with the intervention content - Participants will be asked to complete satisfaction surveys upon study completion to assess the acceptability of the message perceptions about the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa C Kay, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Sarah M Shelton, BSN | Atrium Health Wake Forest Baptist | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2025 | Sep 24, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
| Safety Control | Behavioral | Participants will receive: 1) behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. We will use text messaging to administer the intervention pieces. At baseline, each participant will complete a series of surveys to gain background information. Throughout the study participants will report their goal adherence in response to a text messaging prompt and immediately receive tailored feedback. Text messages will be deployed daily with 2 check in messages per week; participants will receive tailored feedback based on their response. |
|
| Satisfaction Scores - Frequency | Satisfaction with the intervention message frequency - Participants will be asked to complete satisfaction surveys upon study completion to assess the frequency of the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question. | Week 12 |
| Satisfaction Scores - Timing | Satisfaction with the intervention message timing - Participants will be asked to complete satisfaction surveys upon study completion to assess the timing, of the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question. | Week 12 |