Healthy Growth Abbreviated Pilot Study

NCT ID: NCT01977105

Last Updated: 2014-02-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single-group feasibility pilot trial of a peer-based, social media intervention to prevent obesity in infants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pilot Intervention 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.

Group Type EXPERIMENTAL

Grow Together peer group

Intervention Type BEHAVIORAL

Participants in this intervention will:

* Participate in Facebook group of 6-10 peers for about 8 weeks, 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.
* Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network.
* Have basic program information provided to pediatrician to enhance conversation during office visits.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Grow Together peer group

Participants in this intervention will:

* Participate in Facebook group of 6-10 peers for about 8 weeks, 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.
* Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network.
* Have basic program information provided to pediatrician to enhance conversation during office visits.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander G Fiks, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27485934 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-009905

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Parent-Based Treatment for Pediatric Overweight
NCT00807560 COMPLETED PHASE1/PHASE2