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A single-arm, non-randomized four-month trial of the adapted family-based behavioral weight loss treatment (FBT) intervention will be conducted to evaluate its acceptability, feasibility, and preliminary indications of efficacy including measures of relative weight change and associated secondary outcomes (e.g., weight related health behaviors, health related quality of life), among 40 childhood acute lymphoblastic leukemia (ALL) survivors and their families.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children: Family-based Behavioral Weight Loss Treatment (FBT) | Experimental |
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| Caregivers: Family-based Behavioral Weight Loss Treatment (FBT) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-based Behavioral Weight Loss Treatment | Behavioral | The treatment includes: 1) the Traffic Light Eating Plan; 2) the Traffic Light Activity Program, 3) a variety of behavioral change strategies e.g., stimulus control, self-monitoring, planning, goal setting and 4) facilitation of support in the family and peer environments to optimize the durability and generalizability of health habits across multiple social and environmental contexts |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM) | -4 questions about acceptability of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher acceptability of the intervention measure. | At completion of intervention (estimated to be at 4 months) |
| Appropriateness of Family-Based Behavioral Treatment as measured by Intervention Appropriateness Measure (IAM) | -4 questions about appropriateness of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher appropriateness of the intervention measure. | At completion of intervention (estimated to be at 4 months) |
| Acceptability of Family-Based Behavioral Treatment as measured by the Client Satisfaction Questionnaire (CSQ-8) | -8 questions asking about satisfaction of intervention. The CSQ-8 offers four response options for each item (1-4) and an overall score is calculated by summing the respondent's rating score for each item. Scores range from 8-32 with higher scores indicating higher satisfaction. | At completion of intervention (estimated to be at 4 months) |
| Feasibility of Family-Based Behavioral Treatment as measured by Feasibility of Intervention Measure (FIM) | -4 questions about feasibility of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher feasibility of the intervention measure. | At completion of intervention (estimated to be at 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in relative height (children only) | Baseline, end of intervention (at 4 months), 6 months, and 12 months | |
| Change in dietary intake | -Two assisted 24-hour dietary recalls encompassing one weekday and one weekend day and guided by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) will be completed for each participant. This data will be used to measure dietary quality according to the Healthy Eating Index (HEI). The HEI includes a total score as well as sub scores for items such as total fruit intake, whole fruit intake, and total vegetable intake. Total score and sub-scores will be presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica J Jakubiak, MA | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38559896 | Derived | Jakubiak J, Guan M, Khan S, Fowler LA, Bates CR, King AA, Hayashi RJ, Fitzsimmons-Craft E, Wilfley DE. Adaptation of Family-Based Healthy Weight Program for Children who Survived Leukemia. Clin Pract Pediatr Psychol. 2024 Mar;12(1):93-103. doi: 10.1037/cpp0000495. Epub 2023 Oct 5. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Baseline, end of intervention (at 4 months), 6 months, and 12 months |
| Change in relative weight | Baseline, end of intervention (at 4 months), 6 months, and 12 months |
| Change in physical activity as measured by HBSC adaptation | -Self- (for children 10+ years) and parent-reported physical activity behavior will be collected via an adapted version of the Health Behavior in School Age Children survey. This three-question survey assesses the amount of time spent on moderate to vigorous physical activity and sedentary behaviors. | Baseline, end of intervention (at 4 months), 6 months, and 12 months |
| Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) (short) | -The IPAQ measures duration and frequency of activity over the past seven days. An overall score can be calculated, as well as sub-scores for moderate- and vigorous-intensity activity | Baseline, end of intervention (at 4 months), 6 months, and 12 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |