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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL159326 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this clinical trial is to test an online program that teaches healthy habits during pregnancy and infant to prevent early child obesity in Latino families. Specifically, this pilot trial will determine how well we can deliver and test the effects of the program, and how acceptable it is to participants.
The main question it aims to answer are:
• Is a randomized controlled trial of StEP OUT versus infant safety education control feasible to conduct and acceptable to participants? Researchers will compare StEP OUT to infant safety education control to see if participants enroll in and engage with the program, complete surveys, and learn the content we are teaching.
Participants will:
Our objective is to conduct a pilot RCT to evaluate the acceptability, feasibility, and preliminary effectiveness of StEP OUT.
Hypothesis: The intervention and control conditions of StEP OUT will be acceptable to families and feasible, as measured by recruitment, randomization, retention, usability, and fidelity. H3b (exploratory): Families exposed to StEP OUT will have improved obesity-related outcomes (knowledge, styles, practices, and infant adiposity) compared to controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StEP OUT | Experimental | Online nutrition education and parenting support with group chat. |
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| Infant Safety Education | Active Comparator | Periodic text messages with links to prenatal and infant health and safety resources. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StEP OUT | Behavioral | The program consists of five interactive, virtual, group sessions (two prenatal, three post-natal) with a registered dietician/lactation counselor and other women/families of similar gestational age/infant age. Participants discuss maternal nutrition, responsive feeding techniques (breast and bottle), infant feeding cues, and non-feeding soothing methods. Participants are also invited to participate in a moderated WhatsApp Chat with each other to foster additional social engagement and connection. They participate in the program until the baby turns 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability. | From enrollment through the end of the study after child age 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Feasibility assessment will include measures of recruitment (number enrolled of those eligible), retention (number who attend all scheduled sessions of those enrolled), fidelity (number of curriculum components delivered of those planned), and attendance (1. Attendance rate: number of participants who attend each sessions of those scheduled to attend; 2. Program dose: number of sessions attended for each participant) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle W Katzow, MD, MS | Contact | 516-465-4377 | mkatzow@northwell.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health | Recruiting | New Hyde Park | New York | 11040 | United States |
Deidentified IPD underlying the primary outcomes will be shared. Sensitive variables (e.g., location-based identifiers, audio/video files, free-text fields) will not be shared. A data dictionary, protocol, and SAP will be provided.
Data will be available beginning 12 months after publication for 5 years.
Access requires a proposal and a data use agreement.
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| Infant Safety Education | Behavioral | This intervention consists of periodic text messages (approximately every 2 weeks) with links to prenatal health and infant safety information. |
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| From enrollment to study completion after infant age 6 months. |