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This is a single-group feasibility pilot trial of a peer-based, social media intervention to prevent obesity in infants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grow Together peer group | Behavioral | Participants in this intervention will:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
These proportions will be calculated using study recruitment records. | Study end (approximately 2 months) |
| Participant engagement |
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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander G Fiks, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27485934 | Derived | 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. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |