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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
17
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
Washington University School of Medicine
St Louis, Missouri, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At completion of intervention (estimated to be at 4 months)
Change in relative height (children only)
Time frame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
Change in relative weight
Time frame: 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.
Time frame: 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
Time frame: Baseline, end of intervention (at 4 months), 6 months, and 12 months