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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA289519 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to assess the efficacy of a family-based digital (web and mobile phone-based) program known as Healthy Together ("Juntos") in preventing increases in body mass index and improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among Hispanic adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Together ("Juntos") | Experimental | Participants will receive the Healthy Together ("Juntos") digital intervention. The six-month intervention includes an "intensive" phase comprised of eight modules and coaching sessions delivered in the first three months and a "maintenance phase" comprised of three modules and coaching sessions delivered in the subsequent three months. |
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| Control | No Intervention | This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites that they may access at their discretion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Together ("Juntos") | Behavioral | Parent-adolescent dyads will log in to a secured website for six months. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support ("supportive accountability") will be provided. Specifically, each family will be assigned a "coach" who will use video conferencing software to engage in approximately weekly (during the first 3 months), and monthly (during the following 3 months) 20-30-minute sessions regarding the family's progress throughout the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) in adolescents | Will be measured in kg/m^2 | Baseline and up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Moderate-to-Vigorous Physical Activity (MVPA) in adolescents | Will be measured using an Actigraph (counts/seconds (Moderate=757-1111 counts/15-seconds and vigorous>1200 counts/15-seconds)) | Baseline and up to 12 months |
| Change in Diet Quality in adolescents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool |
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Inclusion Criteria:
Adolescent
Parent
Exclusion Criteria:
Adolescent
Parent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara St George, PhD | Contact | 1 (305) 243-0726 | healthyjuntos@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sara St George, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Healthy Eating Index scores range from 0-100, higher scores indicate a higher quality diet |
| Baseline and up to 12 months |
| Change in Percentage of Body Fat in adolescents | Measured in percentage | Baseline and up to 12 months |
| Change in Body Mass Index (BMI) in parents | Will be measured in kg/m^2 | Baseline and up to 12 months |
| Change in Moderate-to-Vigorous Physical Activity (MVPA) in parents | Will be measured using an Actigraph (in counts/minutes (Moderate=2690-6166 - counts/minute; vigorous≥6167 counts/min)) | Baseline and up to 12 months |
| Change in Diet Quality in parents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool | Healthy Eating Index scores range from 0-100, higher scores indicate a higher quality diet | Baseline and up to 12 months |
| Change in Percentage of Body Fat in parents | Measured in percentage | Baseline and up to 12 months |
| Change in Parenting Practices measured by the Parental involvement Scale | Measured by parental involvement subscale of the Parenting Practices measure (4-point Likert scale, higher scores indicate higher parental involvement; parent and adolescent report) | Baseline and up to 12 months |
| Change in Communication measured by Parent Adolescent Communication Scale | Measured by the Parent-Adolescent Communication Scale (5-point Likert scale, higher scores indicate more positive communication; parent and adolescent report) | Baseline and up to 12 months |
| Change in Health-related Positive Parenting Practices measured by the Parenting Strategies for Eating and Activity Scale | Measured by the Parenting Strategies for Eating and Activity Scale (5-point Likert scale, higher scores indicate more use of parent strategies for heathy eating and activity; parent and adolescent report) | Baseline and up to 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |