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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK144911 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This pragmatic randomized clinical trial tests a novel intensive health behavior and lifestyle intervention, conducted via telehealth, to treat class I adolescent obesity in pediatric primary care. Results will inform scalable approaches that meet the recommended treatment dose and effectively treat obesity in this setting.
This trial will test Virtual Housecalls (VHC) in a pragmatic randomized clinical trial with 250 adolescents ages 12-15 years with class 1 (non-severe) obesity (BMI≥95% and <120% of the 95%) and a participating parent/caregiver (N=250 dyads / 500 individuals). VHC includes 26 hours of treatment, by combining in-person PPCP visits (every 3m) with 6m of virtual visits conducted by a behavior coach (3m weekly, 3m every 2 weeks), and weekly exercise videos. The control arm will receive enhanced treatment as usual (TAU+), which includes usual care by their pediatric primary care practitioner (PPCP), augmented with publicly available education, sent on an attention-matched contact schedule. All PPCPs will receive training on the AAP Clinical Practice Guideline for obesity treatment and reports of participant progress at 3, 6, and 12m. Assessments of anthropometrics, dietary intake, physical activity, parenting and the home environment will be completed at 0, 3, 6 (post-intervention), and 12m (maintenance), with the primary endpoint at 6m. The investigators will evaluate the efficacy of VHC on adolescent change in body mass index (primary outcome) and dietary and physical activity behaviors (secondary outcomes). Investigators will also evaluate how treatment dose impacts BMI reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Housecalls Intervention (VHC) | Experimental | Includes standard in-person pediatric primary care, 6 months of telehealth sessions with a behavior coach (3 months with weekly sessions, 3 months with bi-weekly sessions), and weekly exercise videos sent electronically for the 6 month intervention. Sessions include real-time skill building that uses items or space in families' home to tailor the treatment and personalize content application to their context. |
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| Enhanced Treatment as Usual (TAU+) | No Intervention | Includes standard in-person pediatric primary care, enhanced with PPCP training on obesity treatment guidelines and publicly available education regarding healthy eating and exercise, delivered to participants on a contact schedule matched to the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Housecalls | Behavioral | 26 contact hours of evidence-based intensive health and behavioral lifestyle treatment, as per the American Academy of Pediatrics Clinical Practice Guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) Change | Adolescent height (cm) and weight (kg) will be measured in triplicate by trained staff wo are masked to treatment assignment. Height and weight values will be used to calculate Body Mass Index (BMI) specific to age and sex using the Centers for Disease and Control reference data. | 0 - 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) Maintenance | Adolescent height (cm) and weight (kg) will be measured in triplicate by trained staff wo are masked to treatment assignment. Height and weight values will be used to calculate Body Mass Index (BMI) specific to age and sex using the Centers for Disease and Control reference data. | 6 - 12 months |
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Adolescent Inclusion Criteria:
Parent Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah M Farthing, MS | Contact | 804-527-4756 | sarah.malone@vcuhealth.org | |
| Melanie K Bean, PhD | Contact | 804-527-4765 | melanie.bean@vcuhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Melanie K Bean, PhD | Virginia Commonwealth University | Principal Investigator |
| Shari Barkin, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Richmond at VCU Healthy Lifestyles Center | Henrico | Virginia | 23239 | United States |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Assessors and MPIs will be masked to treatment group
| Energy Intake |
Dietary intake (kilocalories/day); total of 1, 24-hour recall per assessment time point. Recalls will be obtained using the Automated Self-Administered 24-hour (ASA-24) dietary assessment tool with the assistance of trained staff who are masked to treatment assignment. Assessment time points include baseline (0), 6-month, and 12-months. |
| 0-6-months, 6-12-months |
| Diet Quality | The Healthy Eating Index (HEI) will be used to measure diet quality using 1, 24-hour recall per assessment time point. Recalls will be obtained using the Automated Self-Administered 24-hour (ASA-24) dietary assessment tool with the assistance of trained staff who are masked to treatment assignment. HEI scores will be calculated from the ASA-24 recall data. Assessment time points include baseline (0), 6-month, and 12-months. | 0-6-months, 6-12-months |
| Physical Activity | The Physical Activity Questionnaire for Adolescents (PAQ-A) will assess changes in time spent participating in moderate to vigorous physical activity (MVPA). | 0-6-months, 6-12-months |
| Treatment Dose | Treatment dose(s) (number and contact time) to yield Body Mass Index (BMI) reductions will be explored. Treatment dose includes all intervention components: 1) parent-teen dyad sessions, 2) parent-only sessions, 3) exercise videos, and 4) standard of care medical visits with pediatric provider. | 0-6-months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |