Clinical trial NCT01977105: Healthy Growth Abbreviated Pilot Study
Official title: Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Infants
Mothers
Social media
Obesity prevention
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Acceptability Survey
timeFrame: Study end (approximately 2 months)
measure: Study population eligibility and interest
timeFrame: Study end (approximately 2 months)
measure: Participant engagement
timeFrame: Study end (approximately 2 months)
measure: Week 1 Curriculum Module Acceptability Survey
timeFrame: 1 week (approximately)
measure: Week 2 Curriculum Module Acceptability Survey
timeFrame: 2 weeks (approximately)
measure: Week 3 Curriculum Module Acceptability Survey
timeFrame: 3 weeks (approximately)
measure: Week 4 Curriculum Module Acceptability Survey
timeFrame: 4 weeks (approximately)
measure: Week 5 Curriculum Module Acceptability Survey
timeFrame: 5 weeks (approximately)
measure: Week 6 Curriculum Module Acceptability Survey
timeFrame: 6 weeks (approximately)
measure: Week 7 Curriculum Module Acceptability Survey
timeFrame: 7 weeks (approximately)
measure: Week 8 Curriculum Module Acceptability Survey
timeFrame: 8 weeks (approximately)
Secondary outcomes:
Other outcomes:
measure: Infant feeding beliefs
timeFrame: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
measure: Infant feeding practices
timeFrame: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
measure: Breastfeeding survey
timeFrame: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
measure: Introduction of solid foods and sugar-sweetened beverages
timeFrame: Study end (approximately 8 weeks)
measure: Infant sleep behaviors
timeFrame: Study end (approximately 8 weeks)
measure: Parenting self-efficacy
timeFrame: Study end (approximately 8 weeks)
measure: Positive parenting behaviors
timeFrame: Study end (approximately 8 weeks)
measure: Maternal self-care behaviors
timeFrame: Study end (approximately 8 weeks)
measure: Maternal social support
timeFrame: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
measure: Maternal stress
timeFrame: Study end (approximately 8 weeks)
measure: Infant weight and growth
timeFrame: Study start (enrollment visit) and study end (approximately 8 weeks)
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Alexander G Fiks, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gruver RS, Bishop-Gilyard CT, Lieberman A, Gerdes M, Virudachalam S, Suh AW, Kalra GK, Magge SN, Shults J, Schreiner MS, Power TJ, Berkowitz RI, Fiks AG. A Social Media Peer Group Intervention for Mothers to Prevent Obesity and Promote Healthy Growth from Infancy: Development and Pilot Trial. JMIR Res Protoc. 2016 Aug 2;5(3):e159. doi: 10.2196/resprot.5276.