NCT Number: NCT07737418
The goal of this study is to learn if a parent-child dyadic physical activity (PA) intervention works to improve physical activity levels in children with leukaemia. It will also learn about the intervention's effects on children's self-confidence in doing physical activity and their quality of life. The main questions it aims to answer are:
Does the dyadic PA intervention increase the amount of physical activity children do, compared with an individual PA intervention or usual care? Does the dyadic PA intervention improve children's confidence in doing physical activity and their overall quality of life? What is the cost-effectiveness of the dyadic intervention relative to the individual intervention and psychological support control group?
Researchers will compare three groups: children and parents doing physical activity together (dyadic intervention), children doing physical activity individually (individual intervention), and children receiving psychological support sessions only (control group), to see if involving parents makes a difference.
Participants will:
Attend weekly sessions for 3 months (12 sessions total) Wear an activity tracker for 7 days and complete questionnaires at 5 different time points over 12 months Some participants will also be invited to take part in an interview about their experience
Trial opening soon.
Get Notified9 year–18 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Parent-child dyads receive a structured physical activity intervention delivered by a trained Research Assistant over 12 weekly sessions across 3 months. Parents perform the physical activity together with their child in each session. Exercise intensity is individually tailored to each child.
Children receive the same structured 12-session, weekly physical activity intervention as the dyadic group, delivered over 3 months by a trained Research Assistant, without parental participation. Exercise intensity is individually tailored to each child.
Children receive 12 weekly sessions of simple psychological support over 3 months, delivered by a trained Research Assistant, without a physical activity component.
Time frame: Baseline and 12 months（T4）
Children's physical activity levels will be objectively measured using ActiGraph GT3X accelerometers, worn for 7 consecutive days at each assessment timepoint. The primary outcome is the minutes engaged in moderate-to-vigorous physical activity (MVPA).
Time frame: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
Children's self-reported PA levels measured using the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth, an 11-point scale (0-10) asking children to self-rate their PA levels in the past 7 days, from 0 (no exercise at all) to 10 (vigorous exercise on most days).
Time frame: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
Children's QoL will be measured using the child-specific EQ-5D-Y-5L scale.
Time frame: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
Children's physical activity self-efficacy will be assessed using the five-item Physical Activity Self-Efficacy Scale. Each item is rated on a three-point Likert scale. Total scores range from 5 to 15, with higher scores indicating greater physical activity self-efficacy.
Contact information is provided by the study sponsor or research team.
The Hong Kong Polytechnic University
Other
Dyadic-based Physical Activity Intervention for Children Who Are Undergoing Cancer Treatment: A Randomized Controlled Trial
Acronym: DYAD-PA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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