NCT02037490

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

January 14, 2014

Last Update Submit

July 5, 2016

Conditions

Childhood Obesity

Keywords

InfantsMothersSocial mediaObesity prevention

Outcome Measures

Primary Outcomes (3)

  • 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.

Other Outcomes (14)

  • Infant feeding practices

    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.)

  • Infant feeding beliefs

    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.)

  • Breastfeeding survey

    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.)

  • +11 more other outcomes

Study Arms (2)

Grow2Gether Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Grow2GetherBEHAVIORAL

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: 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.

Grow2Gether Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander G. Fiks, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

US(2)