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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-05449 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| U54CA132381 | U.S. NIH Grant/Contract | View source | |
| FHIRB0020386 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| New Mexico State University | OTHER |
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This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children. Proper nutrition and physical activity (PA) are essential parts of overall health. Together, they can decrease the risk of developing obesity as well as related diseases such as diabetes, heart disease, stroke, and several types of cancer. To address the prevalence of obesity and related diseases, programs focusing on increasing opportunities for active living and healthy eating are necessary. Multi-component school-based obesity prevention programs have demonstrated increases in PA and improvement in dietary habits; however, most afterschool programs are short term; evidence is needed to confirm long-term effects. Moreover, programs that involve parents have shown to be more successful in helping children choose healthier behaviors. Unfortunately, due to technological advancement, opportunities for children to be active in schools have become more limited in modern society. H-PACE program is based on the national childhood obesity prevention campaign designed to help families, schools, communities, and physicians to raise awareness of nutritional and PA daily guidelines. The H-PACE will encourage daily lifestyle behaviors (five or more servings of fruits and vegetables, two hours or less of recreational screen time, one hour of PA, zero sugary drinks, ten hours of sleep) that impact childhood obesity. This trial is being done to determine whether participating in the H-PACE program may help improve lifestyle behaviors among children.
OUTLINE:
Children attend the H-PACE program comprising educational lessons over 30 minutes, PA over 30 minutes, and healthy snacks twice a week (BIW) for 12 weeks. The educational component includes 30-minute lessons on PA, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) comprises a variety of enjoyable activities including warm-up, main activities (e.g., walk/run/jog and aerobic fun games), and cool-down. The snack component introduces children to tasty and healthy foods and teaches children the skills to enable them to select and prepare healthy snack foods at school and at home. Snack education lessons emphasize the benefits of fruit and vegetable intake, and include a discussion of food composition (e.g., fat content, sugar, sodium). Children prepare healthy snack foods at home with parents once a week (QW) by taking home fruit and vegetable boxes with recipes for family-based engaging activities. Children also wear an accelerometer to monitor activity for 7 days at baseline and during week 11-12. Parents may participate in an optional virtual peer support group on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (H-PACE program) | Experimental | See Detailed Description. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H-PACE Behavioral Intervention | Behavioral | Participate in the H-PACE program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of children who attended more than 75% of program sessions (Feasibility) | Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if > 75% of participants meet the metric. | Up to week 14 |
| Percentage of children who completed more than 80% of assessment activities (Feasibility) | Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if > 75% of participants meet the metric. | Up to week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Mendoza, MD, MPH | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Dejan Magoc, PhD | New Mexico State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Mexico State University | Las Cruces | New Mexico | 88003 | United States | ||
| Fred Hutch/University of Washington Cancer Consortium |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 11, 2026 | |
| Reset | Jun 4, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2025 | Feb 27, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2026 | Jun 4, 2026 | |||
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Accelerometer | Other | Wear an accelerometer |
|
| Questionnaire Administration | Other | Ancillary studies |
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| Supportive Care | Other | Parents may participate in an optional virtual peer support group |
|
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| Seattle |
| Washington |
| 98109 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |