Healthy Growth Abbreviated Pilot Study

N/ACompletedNCT01977105

Children's Hospital of Philadelphia9 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Childhood Obesity

Interventions

Grow Together peer groupBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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