The Effectiveness of an Online FITT-VP Principle Based Exercise Program and Dietary Guidance in the Management of Childhood and Adolescent Obesity.

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This controlled clinical trial aims to compare the effects of an online program that includes exercise guided by the FITT-VP principle and dietary advice, conducted by fitness coaches, in children and adolescents with obesity with a control group that will be enrolled in conventional in-clinic nutrition and exercise advice. All participants will be monitored for 8 months during the active intervention, and followed by 16 months of observation. The study will evaluate the following parameters between groups: BMI, anthropometry, blood biochemistry panel (ALT/AST, lipids, uric acid, HOMA-IR, HbA1c), food frequency questionaire, household survey, satisfaction survey, and adverse events.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 14
Healthy Volunteers: f
View:

• Simple obesity: Body mass index (BMI) between +2SD and +3SD of the reference range: based on the Standard Deviation Curve of BMI for Children 0-18 Years of Age in China, which was developed by the Physical Development Survey of Children in Nine Provinces/Cities in 2005;

• Not participating in other weight management programs currently or in the 3 months prior to the study;

• Accepts to participate and signs informed consent.

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Feihong Luo
luofh@fudan.edu.cn
+862164931226
Backup
Chengjsun Sun
0356117@fudan.edu.cn
+862164932107
Time Frame
Start Date: 2024-02-22
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 60
Treatments
Active_comparator: FITT to CON
Online program that includes exercise guided by the FITT-VP principle and dietary advice for 16 weeks, followed by conventional in-clinic nutrition and exercise advice and self-control for 16 weeks.
Active_comparator: CON to FITT
Conventional in-clinic nutrition and exercise advice and self-control for 16 weeks, followed by online program that includes exercise guided by the FITT-VP principle and dietary advice for 16 weeks.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University
Collaborators: Shanghai Simlab Health Technology

This content was sourced from clinicaltrials.gov

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