Healthy Growth Abbreviated Pilot Study

Study Overview
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Brief Summary
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This is a single-group feasibility pilot trial of a peer-based, social media intervention to prevent obesity in infants.

Detailed Description
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This novel intervention, delivered to mothers primarily through private Facebook groups, will promote behavior change through peer and self-modeling photo/video activities. In this study, we will implement an abbreviated 2-month version of the intervention with a single peer group of up to 10 mothers. We will assess the feasibility and acceptability of both the intervention and our intended outcome measures, in preparation for a randomized pilot trial of the full intervention.

Official Title
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Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Grow Together peer group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age 18 years and older Enrolled in Medicaid at the time of study enrollment Overweight or obese (BMI >= 25, calculated using self-reported pre-pregnancy height and weight) Subjects able to speak, read and write in English Attend their infant's (up to 1 month old) primary care visit at a CHOP Primary Care Network site Received prenatal care Own a smartphone with both a data and text plan Able to use their phone to obtain photographs and videos prior to enrollment Exclusion Criteria: Cannot provide consent. Non-English speaking. Score 10 or greater on Patient Health Questionnaire (PHQ-9) measure for clinical depression Diagnosed with gestational diabetes during pregnancy with their newborn Had a multiple pregnancy. Premature delivery (before 37 weeks) of their newborn. Have a newborn who was hospitalized in the Neonatal Intensive Care Unit (NICU) for one week or longer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Intervention Group<br>Mothers who are screened and determined to be eligible for this single-group pilot study will be enrolled along with their infants in the Grow Together peer group intervention. | Behavioral: Grow Together peer group<br>* Participants in this intervention will: Participate in Facebook group of 6-10 peers for about 8 weeks, led by a professional group mentor. Complete an intervention video activity approximately weekly: 1. View educational videos addressing topics related to healthy infant growth 2. Create photos/videos modeling healthy behaviors and post them to the group 3. Provide and receive feedback on posts 4. Be encouraged to share information with key caregivers of their child Attend group party soon after enrollment, to meet peers and group leader in person. Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network. Have basic program information provided to pediatrician to enhance conversation during office visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Acceptability Survey | Satisfaction with the overall intervention will be assessed for mothers using a standard survey. Subjects will be asked a series of open-ended and Likert-scaled questions. | Study end (approximately 2 months) | 
| Study population eligibility and interest | Proportion of all mothers contacted who meet enrollment criteria Proportion of mothers meeting enrollment criteria who enroll These proportions will be calculated using study recruitment records. | Study end (approximately 2 months) | 
| Participant engagement | Proportion of enrolled mother-infant dyads that comply with intervention participation requirements Proportion of enrolled mother-infant dyads that complete each weekly module activity Proportion of enrolled mother-infant dyads that complete each study measure Number and type of each participant's Facebook group interactions per week (posts, comments, Likes) Frequency, type, and content of each contact between moderator/study staff and each participant This study process data will be obtained from the Facebook group and study records at study end. | Study end (approximately 2 months) | 
| Week 1 Curriculum Module Acceptability Survey | Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions. | 1 week (approximately) | 
| Week 2 Curriculum Module Acceptability Survey | Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions. | 2 weeks (approximately) | 
| Week 3 Curriculum Module Acceptability Survey | Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions. | 3 weeks (approximately) | 
| Week 4 Curriculum Module Acceptability Survey | Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions. | 4 weeks (approximately) | 
| Week 5 Curriculum Module Acceptability Survey | Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions. | 5 weeks (approximately) | 
| Week 6 Curriculum Module Acceptability Survey | Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions. | 6 weeks (approximately) | 
| Week 7 Curriculum Module Acceptability Survey | Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions. | 7 weeks (approximately) | 
| Week 8 Curriculum Module Acceptability Survey | Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions. | 8 weeks (approximately) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants, Mothers, Social media, Obesity prevention