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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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This is a randomized controlled 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, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grow2Gether Intervention | Experimental | Participants in the intervention group will:
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| Control | No Intervention | Participants in the control group will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grow2Gether | Behavioral | 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:
Attend group party soon after enrollment, to meet peers and group leader in person. |
| 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. 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. | After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.) |
| Study population eligibility and interest |
These proportions will be calculated using study recruitment records. | At enrollment |
| Participant engagement |
This study process data will be obtained from the Facebook group and study records at study end. | Ongoing with study activities; to be completed after (within 31 days of) the 25th/final week of the postnatal intervention curriculum. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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 | ||
| The Hospital of the University of Pennsylvania |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 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.) |
| 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). | 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.) |
| Breastfeeding survey | Breastfeeding intent, initiation, and duration will be assessed using a survey | 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.) |
| Introduction of solid foods and sugar-sweetened beverages | Timing of initiation of solid foods and sugar sweetened beverages will be assessed using a survey. | After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.) |
| 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). | 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.) |
| 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). | 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.) |
| 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. | 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). |
| 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. | 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.) |
| 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). | 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.) |
| Maternal depression | 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. | 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.) |
| 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'). | 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.) |
| Infant weight and growth | 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. | 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.) |
| Contraceptive use: Intent and behaviors | 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). | 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.) |
| Maternal weight and height | 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. | 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.) |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |