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This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Lifestyles Intervention Arm | Experimental | Participants will receive the healthy lifestyles intervention. |
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| Education-Only Control Arm | Active Comparator | Participants will receive the education-only intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Lifestyles | Behavioral | 12 telehealth sessions. The first 5 visits include psycho/medical education plus a motivational interviewing component. The second 7 sessions include psycho/medical education plus a problem solving training component. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nutrition knowledge as assessed by the General Nutrition Knowledge Questionnaire | Knowledge of nutrition recommendations, as evidenced by scores on the General Nutrition Knowledge Questionnaire - Revised (higher scores indicate greater knowledge). | Pre-intervention and 2 months after the intervention concludes |
| Change in Physical activity knowledge as assessed by the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire | Knowledge of physical activity recommendations, as evidenced by scores on the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire (higher scores indicate greater knowledge). | Pre-intervention and 2 months after the intervention concludes |
| Change in Physical activity as assessed by Fitbit data | Physical activity total weekly minutes, as evidenced by weekly Fitbit data (activity measured in minutes). | Pre-intervention and 2 months after the intervention concludes |
| Change in Nutrition as assessed by the Rapid Eating Assessment for Patients score | Adherence to United States Department of Agriculture recommendations, as evidenced by the Rapid Eating Assessment for Patients (higher scores indicate better adherence to recommendations). | Pre-intervention and 2 months after the intervention concludes |
| Intervention feasibility as assessed by the fidelity rating | Feasibility of conducting the intervention with high clinician fidelity, as evidenced by fidelity ratings for each session (fidelity represented as a percentage based on the extent to which the clinician covered all planned information for each session). Average intervention fidelity ratings should meet or exceed 80% fidelity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Healthy lifestyle self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire Short Form | Self-efficacy managing weight, as evidenced on scores on the Weight Efficacy Lifestyle Questionnaire Short Form (greater scores indicate greater self-efficacy). | Pre-intervention and 2 months after the intervention concludes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa A. Faith, Ph.D., ABPP | Johns Hopkins All Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001835 | Body Weight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
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This is a small feasibility study. We will enroll 24 participants on the intervention arm and 12 participants to an education-only control arm.
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| Education-Only Control | Behavioral | This control condition includes meeting with a clinician for one telehealth visit to review nutrition and physical activity recommendations. |
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| Immediately following intervention |
| Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile | Patient and caregiver acceptability of the newly developed intervention, as evidenced by the Abbreviated Acceptability Rating Profile (higher scores indicate greater acceptability, with scores equal to or greater than 30 indicating good acceptability per published standards). | Immediately following intervention |
| Change in Healthy lifestyle self-efficacy as assessed by the Healthy Promoting Lifestyle Profile II |
Self-efficacy maintaining healthy lifestyle behaviors, as evidenced by scores on the Healthy Promoting Lifestyle Profile II ((greater scores indicate greater self-efficacy). |
| Pre-intervention and 2 months after the intervention concludes |
| Change in Body satisfaction as assessed by the Body Esteem Scale for Adults and Adolescents | Body satisfaction, as evidenced by scores on the Body Esteem Scale for Adults and Adolescents (higher scores indicate greater body satisfaction). | Pre-intervention and 2 months after the intervention concludes |
| Change in Depression as assessed by the PROMIS Depressive Symptoms-Short Form | Depressive symptoms, as evidenced by scores on the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form (greater scores indicate greater depressive symptoms). | Pre-intervention and 2 months after the intervention concludes |
| Change in Anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form | PROMIS Pediatric Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form (greater scores indicate greater anxiety symptoms). | Pre-intervention and 2 months after the intervention concludes |
| Change in Self-esteem as assessed by the Rosenberg Self Esteem Scale | Self-esteem, as evidenced by scores on the Rosenberg Self Esteem Scale (greater scores indicate greater self-esteem). | Pre-intervention and 2 months after the intervention concludes |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |