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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM144270 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.
Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months.
The other group will be in our Healthy Lifestyle program for 6 months. This will include:
The main questions the study aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Lifestyle | Experimental | Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. |
|
| Standard of Care | Active Comparator | Weight checks and lifestyle counseling with primary care provider every other month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Lifestyle | Behavioral | Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Adiposity | Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. | 6 months |
| Visit Adherence | Lost to follow-up (attrition) from study as documented in the electronic health record. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment. |
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Caregiver and child dyads will be enrolled
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thao-Ly T Phan, MD, MPH | Nemours Children's Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Health, Milford | Milford | Delaware | 19963 | United States | ||
| Nemours Children's Health, Millsboro |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Lifestyle | Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. |
| FG001 | Standard of Care | Weight checks and lifestyle counseling with primary care provider every other month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Lifestyle | Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Child Adiposity | Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. | 7 participants did not have anthropometric measurements collected in the EHR at the end of study | Posted | Mean | Standard Deviation | Change in BMI percentile | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Lifestyle | Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thao-Ly Phan, Associate Professor of Pediatrics | Nemours Children's Health | 302-331-7342 | tphan@nemours.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2024 | May 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Behavioral | Weight checks and lifestyle counseling with primary care provider every other month. |
|
| 6 months |
| Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Differences in lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment. | 6 months |
| Millsboro |
| Delaware |
| 19966 |
| United States |
| Nemours Children's Health, Seaford | Seaford | Delaware | 19973 | United States |
| Standard of Care |
Weight checks and lifestyle counseling with primary care provider every other month. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| BMI percentile above the 95th percentile | American Academy of Pediatrics guidelines recommend using percentiles of the 95th percentile of BMI-for-age to indicate different levels of severe obesity. More information on the methodology for this can be found at https://www.cdc.gov/growthcharts/extended-bmi-data-files.htm. | Mean | Standard Deviation | BMI percentile above the 95th percentile |
|
Weight checks and lifestyle counseling with primary care provider every other month. |
|
|
| Primary | Visit Adherence | Lost to follow-up (attrition) from study as documented in the electronic health record. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics | Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment. | 7 participants did not have anthropometric measures recorded in the EHR at baseline and study end due to lost to follow-up | Posted | Mean | Standard Deviation | Change in BMI percentile | 6 months |
|
|
|
| Secondary | Differences in Visit Adherence Based on Child Sociodemographic Characteristics | Differences in lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment. | Number analyzed in rows below are only those who were lost to follow-up (attrition) for each race, ethnicity, or insurance category | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Standard of Care | Weight checks and lifestyle counseling with primary care provider every other month. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Non-Hispanic Black |
|
|
| Hispanic or Latino |
|
|
| Private Insurance |
|
|
| Public Insurance |
|
|
| Non-Attrition |
|
| Non-Hispanic White |
|
|
| Hispanic or Latino |
|
|