Effects of Aerobic Exercise and Diet on Weight in Children with Down Syndrome
Effects of Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Overweight and Obese Children With Down Syndrome
This study is testing whether kids with Down syndrome who are overweight can lose weight and improve their health by doing aerobic exercise alone or by combining it with a low-calorie diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 8 Years to 16 Years |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT06943170 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of aerobic exercise alone versus aerobic exercise combined with a low-calorie diet on reducing adiposity and improving body mass index (BMI) in children with Down syndrome. Participants aged 8 to 16 years who are overweight or obese will be randomly assigned to one of two groups: one will engage in aerobic exercise, while the other will follow the same exercise regimen along with a low-calorie diet. The study will utilize calibrated scales, stadiometers, and waist circumference measurements to assess changes in weight and body composition over a 10-month period. The research is being conducted at a rehabilitation clinic in Lahore, Pakistan.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8 to 16 years with Down syndrome who are classified as overweight or obese.
Not a fit: Patients with significant co-morbidities, physical disabilities, or severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective strategies for weight management in children with Down syndrome, potentially improving their overall health and quality of life.
How similar studies have performed: Other studies have shown positive outcomes with exercise and dietary interventions in similar populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age (8-16) years. * Both Genders (Male and Female). * BMI-for-age percentile (at or above 85th percentile is overweight, and at or above 95th percentile is considered as obese) * Children with generally stable health condition, without significant co-morbidities that might affect diet or exercise interventions. * Consent form signed by parents, along with written approval by the physician. Exclusion Criteria: * History of any previous medical disease. * Previous Participation in any Weight Loss Exercise Program. * Participants following any specific diet plan from last 6 months. * Exclusion of children on medication that could affect weight or metabolism. * Children with physical disabilities that prevent them from safely participating in aerobic exercise. * Children with dietary restrictions or food allergies. * Children with severe cognitive impairments that prevent them from engaging in exercise program.
Where this trial is running
Lahore, Punjab Province
- Jannat Arshad — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Jannat Arshad, MS-PT — Riphah International University
- Study coordinator: Imran Amjad, PhD
- Email: imran.amjad@riphah.edu.pk
- Phone: 9233224390125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.