Clinical trial NCT02037490: Grow2Gether Pilot Study
Official title: Grow2Gether: 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
Collaborators: name: University of Pennsylvania
First posted: 2014-01-16
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.)

Primary outcomes:
measure: Intervention Acceptability Survey
timeFrame: After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.)
measure: Study population eligibility and interest
timeFrame: At enrollment
measure: Participant engagement
timeFrame: Ongoing with study activities; to be completed after (within 31 days of) the 25th/final week of the postnatal intervention curriculum.
Secondary outcomes:
Other outcomes:
measure: Infant feeding practices
timeFrame: At (or within 31 days of) the infant's newborn primary care visit, and during (or within 31 days of ) the 8th, 17th, and 25th/final week of the postnatal intervention curriculum. (Approx. 2, 4, 6 and 8 months from each peer group's start, respectively.)
measure: Infant feeding beliefs
timeFrame: At (or within 31 days of) the infant's newborn primary care visit, and during (or within 31 days of ) the 25th/final week of the postnatal intervention curriculum. (Approx. 2 and 8 months from each peer group's start, respectively.)
measure: Breastfeeding survey
timeFrame: At enrollment, at (w/in 31 days of) infant's newborn primary care visit, during (w/in 31 days of) the 8th, 17th, and 25th/final week of postnatal intervention curriculum. (Baseline & approx. 2, 4, 6 & 8 mos from each peer group's start, respectively.)
measure: Introduction of solid foods and sugar-sweetened beverages
timeFrame: After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.)
measure: Infant sleep behaviors
timeFrame: At (or within 31 days of) the infant's newborn primary care visit, and during (or within 31 days of ) the 8th, 17th, and 25th/final week of the postnatal intervention curriculum. (Approx. 2, 4, 6 and 8 months from each peer group's start, respectively.)
measure: Parenting self-efficacy
timeFrame: At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)
measure: Positive parenting behaviors
timeFrame: At (or within 31 days of) the infant's newborn primary care visit, and during (or within 31 days of ) the 8th and 25th/final week of the postnatal intervention curriculum. (Approx. 2, 4, and 8 months from each peer group's start, respectively).
measure: Maternal self-care behaviors
timeFrame: At (or within 31 days of) the infant's newborn primary care visit, and during (or within 31 days of ) the 8th, 17th, and 25th/final week of the postnatal intervention curriculum. (Approx. 2, 4, 6 and 8 months from each peer group's start, respectively.)
measure: Maternal social support
timeFrame: At enrollment and during (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Baseline & approximately 8 mos from each peer group's start, respectively.)
measure: Maternal depression
timeFrame: At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)
measure: Maternal stress
timeFrame: At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)
measure: Infant weight and growth
timeFrame: At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)
measure: Contraceptive use: Intent and behaviors
timeFrame: At enrollment, and after (within 31 days of) the 25th/final week of the postnatal intervention curriculum (approximately 8 months from each peer group's start.)
measure: Maternal weight and height
timeFrame: At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Alexander G. Fiks, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: