Healthy Growth Abbreviated Pilot Study

Not Applicable

Completed

• Conditions: Childhood Obesity
• Interventions: Behavioral: Grow Together peer group

• Registration Number: NCT01977105
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

This is a single-group feasibility 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, 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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot Intervention Group	Grow Together peer group	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.

Primary Outcome Measures

Name	Time	Method
Intervention Acceptability Survey	Study end (approximately 2 months)	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 population eligibility and interest	Study end (approximately 2 months)	* 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.
Participant engagement	Study end (approximately 2 months)	* 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.
Week 1 Curriculum Module Acceptability Survey	1 week (approximately)	Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 2 Curriculum Module Acceptability Survey	2 weeks (approximately)	Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 3 Curriculum Module Acceptability Survey	3 weeks (approximately)	Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 4 Curriculum Module Acceptability Survey	4 weeks (approximately)	Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 5 Curriculum Module Acceptability Survey	5 weeks (approximately)	Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 6 Curriculum Module Acceptability Survey	6 weeks (approximately)	Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 7 Curriculum Module Acceptability Survey	7 weeks (approximately)	Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 8 Curriculum Module Acceptability Survey	8 weeks (approximately)	Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States