Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01977105
Other study ID # 12-009905
Secondary ID
Status Completed
Phase N/A
First received September 30, 2013
Last updated February 4, 2014
Start date September 2013
Est. completion date December 2013

Study information

Verified date February 2014
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Infant feeding beliefs 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). Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks) No
Other Infant feeding practices 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).
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks) No
Other Breastfeeding survey Breastfeeding intent, initiation, and duration will be assessed using a survey Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks) No
Other Introduction of solid foods and sugar-sweetened beverages Timing of initiation of solid foods and sugar sweetened beverages will be assessed using a survey. Study end (approximately 8 weeks) No
Other Infant sleep behaviors 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). Study end (approximately 8 weeks) No
Other Parenting self-efficacy 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). Study end (approximately 8 weeks) No
Other Positive parenting behaviors 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. Study end (approximately 8 weeks) No
Other Maternal self-care behaviors 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. Study end (approximately 8 weeks) No
Other Maternal social support 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). Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks) No
Other Maternal stress 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'). Study end (approximately 8 weeks) No
Other Infant weight and growth 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. Study start (enrollment visit) and study end (approximately 8 weeks) No
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
See also
  Status Clinical Trial Phase
Recruiting NCT05437406 - Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC) N/A
Completed NCT03297541 - Healthy Kids I-PAL N/A
Completed NCT05527938 - Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children N/A
Completed NCT05501392 - South Texas Early Prevention Studies PreK N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Active, not recruiting NCT03342092 - Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté N/A
Completed NCT06239662 - Therapeutic Education Groups for Childhood Obesity N/A
Withdrawn NCT02767830 - Cleveland Kids Run N/A
Not yet recruiting NCT02889406 - Motivation Approach for Childhood Obesity Treatment N/A
Completed NCT03245164 - The Effects of Group Exercise and Basketball on Obese Children N/A
Completed NCT02559076 - The Eat Right Emirates Healthy Lifestyle Study N/A
Completed NCT02484976 - Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging N/A
Completed NCT02087774 - Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children N/A
Completed NCT01849315 - Effects of Physical Activity on Disease Risk Factors N/A
Completed NCT01821313 - CASH- Children Active to Stay Healthy N/A
Completed NCT01789671 - Peer Counseling in Family-Based Treatment for Childhood Obesity N/A
Completed NCT02637752 - Nutrition and Physical Activity Counselling N/A
Completed NCT02799433 - Evaluation of the Healthy Apple Program in San Francisco N/A
Completed NCT00854334 - Co-existent Obstructive Sleep Apnea (OSA) and Obesity: Finding Non-exercise Activity Thermogenesis (NEAT) Targets for Intervention N/A
Completed NCT01246349 - Motivational Interviewing for Weight Loss N/A