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Poor patient compliance and Withdrawal of support from the exercise training institution
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| Name | Class |
|---|---|
| Shanghai Simlab Health Technology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FITT to CON | Active Comparator | 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. |
|
| CON to FITT | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online program that includes exercise guided by the FITT-VP principle and dietary advice | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Reduction in body mass index (the body mass [kg] divided by the square of the body height [m]) | 16, 32, 52, 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary habits | Change in dietary habits assessed by food frequency questionaire (2015 CHNS) | 16, 32, 52, 104 weeks |
| AE | Adverse events during active intervention by questionaire and healthcare records according to local regulations (PMID: 34327433) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
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|
| Conventional in-clinic nutrition and exercise advice and self-control | Behavioral | Physicians provide instructions on exercise and nutrition (total daily calorie intake) for the patients to conduct self-control for 16 weeks. |
|
| 16, 32, 52, 104 weeks |
| Uric acid | Reduction in serum uric acid levels | 16, 32 weeks |
| Tch | Reduction in serum total cholesterol | 16, 32 weeks |
| LDL-c | Reduction in serum low density lipoprotein cholesterol | 16, 32 weeks |
| HbA1c | Reduction in glycated hemoglobin | 16, 32 weeks |
| HOMA-IR | Reduction in this surrogate marker of beta-cell function and insulin resistance (IR) from basal (fasting) glucose and concentrations. | 16, 32 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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