Grow2Gether Pilot Study

NCT ID: NCT02037490

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Grow2Gether Intervention

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.

Group Type EXPERIMENTAL

Grow2Gether

Intervention Type BEHAVIORAL

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Grow2Gether

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander G. Fiks, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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13-010702

Identifier Type: -

Identifier Source: org_study_id

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