Clinical trial NCT06254508: Online Exercise Program and Dietary Advice (FITT-online) for Children and Adolescents With Obesity
Official title: The Effectiveness of an Online FITT-VP Principle Based Exercise Program and Dietary Guidance in the Management of Childhood and Adolescent Obesity.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Simlab Health Technology
First posted: 2024-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. 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;
2. Not participating in other weight management programs currently or in the 3 months prior to the study;
3. Accepts to participate and signs informed consent.

Exclusion Criteria:

1. Currently taking or planning to take medications or interventions that affect body weight during the study period (32 weeks)
2. Obesity caused by other medical conditions. For example, hypothalamic-pituitary disease, hypothyroidism, growth hormone deficiency, Cushing's syndrome, obesity-related syndromes.
3. Comorbidity with other chronic diseases. E.g. psychiatric diseases, respiratory diseases, gastrointestinal diseases, rheumatic diseases, hepatic and renal insufficiency, chronic infectious diseases;
4. Presence of abnormal laboratory values at the time of screening indicating a clinically significant underlying disease or condition that may prevent the subject from participating in the study; or presence of abnormalities in the following laboratory tests: alanine aminotransferase (ALT) greater than 5 times the upper limit of normal, serum creatinine (Scr) greater than 1.5 times the upper limit of normal.
5. Contraindications to physical exercise or exercise-related risks. For example, history of asthma, history of hypoglycemia/diabetes, history of heart disease, history of cardiovascular disease, fracture/surgery/planned surgery within the last 1 year, psychomotor retardation, motor system defects/disabilities, previous history of exercise intolerance;

Primary outcomes:
measure: BMI
timeFrame: 16, 32, 52, 104 weeks
Secondary outcomes:
measure: Dietary habits
timeFrame: 16, 32, 52, 104 weeks
measure: AE
timeFrame: 16, 32, 52, 104 weeks
measure: Uric acid
timeFrame: 16, 32 weeks
measure: Tch
timeFrame: 16, 32 weeks
measure: LDL-c
timeFrame: 16, 32 weeks
measure: HbA1c
timeFrame: 16, 32 weeks
measure: HOMA-IR
timeFrame: 16, 32 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References: