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Grow2Gether Pilot Study

Primary Purpose

Childhood Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Grow2Gether

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Infants, Mothers, Social media, Obesity prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.)

Sites / Locations

The Children's Hospital of Philadelphia
The Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Grow2Gether Intervention

Control

Arm Description

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.

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.

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. 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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02037490

First Posted

January 14, 2014

Last Updated

July 5, 2016

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT02037490

Brief Title

Grow2Gether Pilot Study

Official Title

Grow2Gether: Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized controlled 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, 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.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Grow2Gether Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Grow2Gether

Intervention Description

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: View educational videos addressing topics related to healthy infant growth Create photos/videos modeling healthy behaviors and post them to the group Provide and receive feedback on posts 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.

Primary Outcome Measure Information:

Title

Intervention Acceptability Survey

Description

Time Frame

After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.)

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

At enrollment

Title

Participant engagement

Description

Time Frame

Ongoing with study activities; to be completed after (within 31 days of) the 25th/final week of the postnatal intervention curriculum.

Other Pre-specified Outcome Measures:

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

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.)

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

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.)

Title

Breastfeeding survey

Description

Breastfeeding intent, initiation, and duration will be assessed using a survey

Time Frame

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.)

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

After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.)

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

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

At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)

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

At (or within 31 days of) the infant's newborn primary care visit, and during (or within 31 days of ) the 8th and 25th/final week of the postnatal intervention curriculum. (Approx. 2, 4, and 8 months from each peer group's start, respectively).

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

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

At enrollment and during (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Baseline & approximately 8 mos from each peer group's start, respectively.)

Title

Maternal depression

Description

The Patient Health Questionnaire-9 (PHQ-9), a validated 9-item scale, will be used to measure maternal depression at follow-up visits. This brief scale asks about the frequency of depression symptoms experienced over the past week (where 0 = Not at all, 1 = Several days, 2 = More than half the days, and 3 = Nearly every day), and produces an overall score ranging from 0 - 27. Participants who score 10 or greater will be contacted, screened for suicidality by a psychologist and offered referrals to supportive services.

Time Frame

At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)

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

At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)

Title

Infant weight and growth

Description

Infants' weight will be measured using a calibrated digital scale and length will be measured using a standard infantometer. Measurements will be taken by a member of the study staff trained in anthropometric measures. Infants birth weight will also be obtained from medical records.

Time Frame

At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)

Title

Contraceptive use: Intent and behaviors

Description

At enrollment, future plans for contraceptive use will be assessed; in the final survey, 3 questionnaire items will assess contraceptive use behaviors since delivery. All questionnaire items have been adapted from the Centers for Disease Control and Prevention (CDC) Youth Risk Behavior Survey (YRBS).

Time Frame

At enrollment, and after (within 31 days of) the 25th/final week of the postnatal intervention curriculum (approximately 8 months from each peer group's start.)

Title

Maternal weight and height

Description

Mothers' weight will be measured using a calibrated digital scale and height will be measured using a standard stadiometer. Measurements will be taken by a member of the study staff trained in anthropometric measures. Maternal pre-pregnancy height and weight will also be obtained from medical records.

Time Frame

At (or within 31 days of) the 8th and 25th/final weeks of the postnatal intervention curriculum. (Approx. 4 and 8 months from each peer group's start, respectively.)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

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

Facility Name

The Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Grow2Gether Pilot Study

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