Back to resultsHealthy Growth Abbreviated Pilot Study
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grow Together peer group
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Infants, Mothers, Social media, Obesity prevention
Eligibility Criteria
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.
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilot Intervention Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01977105
First Posted
September 30, 2013
Last Updated
February 4, 2014
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT01977105
Brief Title
Healthy Growth Abbreviated Pilot Study
Official Title
Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-group feasibility 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Infants, Mothers, Social media, Obesity prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilot Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Grow Together peer group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intervention Acceptability Survey
Description
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.
Time Frame
Study end (approximately 2 months)
Title
Study population eligibility and interest
Description
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.
Time Frame
Study end (approximately 2 months)
Title
Participant engagement
Description
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.
Time Frame
Study end (approximately 2 months)
Title
Week 1 Curriculum Module Acceptability Survey
Description
Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Time Frame
1 week (approximately)
Title
Week 2 Curriculum Module Acceptability Survey
Description
Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Time Frame
2 weeks (approximately)
Title
Week 3 Curriculum Module Acceptability Survey
Description
Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Time Frame
3 weeks (approximately)
Title
Week 4 Curriculum Module Acceptability Survey
Description
Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Time Frame
4 weeks (approximately)
Title
Week 5 Curriculum Module Acceptability Survey
Description
Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Time Frame
5 weeks (approximately)
Title
Week 6 Curriculum Module Acceptability Survey
Description
Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Time Frame
6 weeks (approximately)
Title
Week 7 Curriculum Module Acceptability Survey
Description
Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Time Frame
7 weeks (approximately)
Title
Week 8 Curriculum Module Acceptability Survey
Description
Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Time Frame
8 weeks (approximately)
Other Pre-specified Outcome Measures:
Title
Infant feeding beliefs
Description
Maternal beliefs regarding infant feeding will be measured using the Infant Feeding Style Questionnaire (IFSQ), which contains 10 items measuring beliefs, coded on a 5-point scale (disagree, slightly disagree, neutral, slightly agree, agree).
Time Frame
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Title
Infant feeding practices
Description
Maternal behaviors related to infant feeding will be measured using 10 items on the Infant Feeding Style Questionnaire (IFSQ). Behavior items are coded on a 5-point scale (never, seldom, half of the time, most of the time, always).
Also, four items from the validated Infant Feeding Practices Questionnaire (IFPQ) will be used to assess maternal feeding practices related to obesity. The IFPQ contains 20 items, with a 5-point adapted Likert response scale ranging from 0 (Never) to 4 (Always).
Time Frame
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Title
Breastfeeding survey
Description
Breastfeeding intent, initiation, and duration will be assessed using a survey
Time Frame
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Title
Introduction of solid foods and sugar-sweetened beverages
Description
Timing of initiation of solid foods and sugar sweetened beverages will be assessed using a survey.
Time Frame
Study end (approximately 8 weeks)
Title
Infant sleep behaviors
Description
Infant sleeping and related maternal activities will be measured using the validated Brief Infant Sleep Questionnaire (BISQ). Subjects will complete the abbreviated 13-item BISQ (A-BISQ), as well as 2 additional questions from the expanded version (E-BISQ).
Time Frame
Study end (approximately 8 weeks)
Title
Parenting self-efficacy
Description
The Karitane Parenting Confidence Scale (KPCS) is a 15-item validated scale that will be used to measure parenting self-efficacy. Questions assess the frequency of certain beliefs, skills and abilities related to successful parenting, measured using a 4-point response structure (No, hardly ever; No, not very often; Yes, some of the time; Yes, most of the time).
Time Frame
Study end (approximately 8 weeks)
Title
Positive parenting behaviors
Description
Mothers will be assessed regarding specific parenting practices using the 10-item Infant/Toddler (IT) Home Observation for Measurement of the Environment (HOME) Inventory. Individual responses for each yes/no item are coded to 0 or 1.
Time Frame
Study end (approximately 8 weeks)
Title
Maternal self-care behaviors
Description
Mothers will be asked 11 questions related to their self-care behaviors, including their own sleep habits, support-seeking behaviors, and taking time for themselves. These items are a combination of Likert-scaled items and simple measures of the frequency of behaviors.
Time Frame
Study end (approximately 8 weeks)
Title
Maternal social support
Description
Mothers' level of social support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). This validated scale is made up of 12 items. Responses for this scale are coded from 1 to 7 (very strongly disagree, strongly disagree, mildly disagree, neutral, mildly agree, strongly agree, and very strongly agree).
Time Frame
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Title
Maternal stress
Description
The Parental Stress Scale (PSS) is a validated, 18-item public domain scale measuring perceived parental stress using a 5-point Likert rating scale ('Strongly disagree' to 'strongly agree').
Time Frame
Study end (approximately 8 weeks)
Title
Infant weight and growth
Description
Infants' weight will be measured using using a calibrated digital scale and length will be measured using a standard infantometer. Measurements will be taken by a trained nurse or other trained staff member at the primary care recruitment sites, or by a member of the study staff trained in anthropometric measures.
Time Frame
Study start (enrollment visit) and study end (approximately 8 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander G Fiks, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27485934
Citation
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.
Results Reference
derived
Learn more about this trial
Healthy Growth Abbreviated Pilot Study
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