Healthy Growth Abbreviated Pilot Study

NCT01977105 | Completed

• 1 other identifier: 12-009905
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Childhood Obesity

Keywords

Infants; Mothers; Social media; Obesity prevention

Outcome Measures

Primary Outcomes (11)

• 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.

  Study end (approximately 2 months)

• 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.

  Study end (approximately 2 months)

• 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.

  Study end (approximately 2 months)

• Week 1 Curriculum Module Acceptability Survey

  Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

  1 week (approximately)

• Week 2 Curriculum Module Acceptability Survey

  Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

  2 weeks (approximately)

• Week 3 Curriculum Module Acceptability Survey

  Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

  3 weeks (approximately)

• Week 4 Curriculum Module Acceptability Survey

  Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

  4 weeks (approximately)

• Week 5 Curriculum Module Acceptability Survey

  Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

  5 weeks (approximately)

• Week 6 Curriculum Module Acceptability Survey

  Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

  6 weeks (approximately)

• Week 7 Curriculum Module Acceptability Survey

  Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

  7 weeks (approximately)

• Week 8 Curriculum Module Acceptability Survey

  Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.

  8 weeks (approximately)

Other Outcomes (11)

• Infant feeding beliefs

  Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)

• Infant feeding practices

  Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)

• Breastfeeding survey

  Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)

Study Arms (1)

Pilot Intervention Group

EXPERIMENTAL

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.

Behavioral: Grow Together peer group

Interventions

Grow Together peer group 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.

Pilot Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 27485934 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological 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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: November 6, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 6, 2014

Record last verified: 2014-02

Locations

US (1)