Grow2Gether Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled pilot trial of a peer-based, social media intervention to prevent obesity in infants.

Detailed Description
-----------------
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, investigators will implement the intervention with small peer groups of 6-12 mothers, beginning during the 3rd trimester of pregnancy. Investigators will assess feasibility and acceptability of the intervention, and explore its impact on outcomes, particularly behaviors associated with healthy growth.

Official Title
-----------------
Grow2Gether: Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: Grow2Gether


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving prenatal care from Hospital of the University of Pennsylvania (HUP) obstetrics practices Age 18 years and older Able to provide informed consent Able to speak, read and write in English Enrolled in Medicaid at the time of study enrollment Overweight or obese (BMI ≥ 25, calculated using height and weight recorded at a prenatal visit prior to 14 weeks of pregnancy) In ≥ 20th week of pregnancy Plan to receive their child's primary care services from Children's Hospital of Philadelphia (CHOP) Care Network 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: Current diagnosis or history of major mental illness, as indicated in medical record by notation of (1) diagnosis or history of condition (2) current use or history of antidepressants or other psychotropic medication, or (3) referral to, or under care of a psychiatrist. Multiple pregnancy (twins, triplets, etc.) Severe morbidity (significant cardiac disease, significant organ dysfunction, transplant recipient, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grow2Gether Intervention<br>Participants in the intervention group will: Participate in the Grow2Gether intervention Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network. | Behavioral: Grow2Gether<br>* Participants in this intervention will: Participate in Facebook group of 6-12 peers for about 8 months, led by a professional group mentor. Complete an intervention video activity approximately weekly: View educational videos addressing topics related to healthy infant growth Create photos/videos modeling healthy behaviors and post them to the group Provide and receive feedback on posts 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.<br>|
| No Intervention: Control<br>Participants in the control group will: Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network. | |

What is the study measuring?
-----------------
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. Additionally, participants with certain characteristics (such as relatively high or low rates of group participation) will be purposively selected for brief semi-structured interviews based on the survey content to further elucidate their opinion of the intervention. | After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.) | 
| 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. | At enrollment | 
| 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. | Ongoing with study activities; to be completed after (within 31 days of) the 25th/final week of the postnatal intervention curriculum. | 

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