A Study of Eating, Exercising, Sleeping, and Obesity in Children with Neurodevelopmental Disabilities

JRCT ID: jRCT1020240023

Registered date:17/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: overweight, obesity, developmental disability
• Date of first enrollment: 01/10/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): After obtaining informed consent, participants will wear a wearable device (Fitbit Charge 6, Google) on their non-dominant wrist. The Fitbit will be worn from after school until the following morning and on weekends for one month. Physical activity and sleep patterns will be analyzed over the one month period. In addition, a brief-type self-administered diet history questionnaire (BDHQ) will be used to assess dietary intake and nutritional status. Participants with a body mass index (BMI) at or above the 85th percentile or with an obesity level of 20% or greater will receive feedback on their results and be provided with lifestyle counseling. Follow-up assessments using the BDHQ and Fitbit will be conducted 6 and 12 months after the initial assessment to evaluate changes in diet, physical activity, sleep patterns, and BMI.

Outcome(s)

• Primary Outcome: Change in BMI with intervention

Secondary Outcome

1. Relationships between BMI and nutritional status, physical activity, and sleep
2. Wearable device retention and adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 18age old
• Gender: Both
• Include criteria: Students ages 6 to 18 with developmental disabilities such as autism spectrum disorder and attention-deficit/hyperactivity disorder

Exclude criteria

1. Patients with conditions strongly associated with obesity, such as Prader-Willi syndrome and Down syndrome, metabolic disorders, endocrine disorders, and chronic wasting disease that affect growth
2. Patients who have difficulty wearing the wearable device at all times due to hypersensitivity, skin conditions, or wounds
3. Those for whom the size of the wearable device does not fit their physique

Related Information

• Primary Sponsor: Suzuki Tomohisa