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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to evaluate the efficacy of a distance follow-up on body mass index decrease at 15 months compared to traditional management in obese adolescents.
Childhood obesity continues to be a key challenge in France. The unit is facing a high demand with limited resources, moreover despite an intensive program of care with a multidisciplinary dedicated team, the impact on weight loss is moderate.
The hypothesis is to ameliorate results by using distance monitoring in maintenance phase.
After a traditional intensive period consisting in a weekly family-based multidisciplinary intervention, patients are randomized in two arms, traditional or distance follow-up.
Traditional follow-up is based on face-to-face multidisciplinary consultations every three months.
The distance monitoring is based on a mobile application dedicated to food behavior change and physical activity, with weekly self-monitoring, goal setting, physical activity and healthy eating support, monthly weight assessment. Pre-programmed feedbacks "motivational strategies" are included.
After one year of follow-up, adolescents are evaluated for weight loss, compliance and quality of life. The two groups will be compared.
The question is can mobile apps help to monitor and promote healthy lifestyle in obese adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional follow-up | Active Comparator |
| |
| Distance follow-up "new technologies" | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| traditional follow_up | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Body Mass Index Z-score | Body mass index z score is calculated using french reference data. success: decrease of Body Mass Index Z-score from baseline to 15 months of 0.5 standard deviation | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean difference of Body Mass Index Z-score between the two groups | 15 months | |
| Percent of loss to follow-up | 15 months | |
| Change from baseline in PedsQL score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myriam DABBAS, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker-Enfants malades Hospital | Paris | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24485327 | Background | O'Malley G, Clarke M, Burls A, Murphy S, Murphy N, Perry IJ. A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial. Trials. 2014 Jan 31;15:43. doi: 10.1186/1745-6215-15-43. | |
| 25641770 | Background | Turner T, Spruijt-Metz D, Wen CK, Hingle MD. Prevention and treatment of pediatric obesity using mobile and wireless technologies: a systematic review. Pediatr Obes. 2015 Dec;10(6):403-9. doi: 10.1111/ijpo.12002. Epub 2015 Jan 12. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| distance follow-up "new technologies" | Behavioral |
|
|
| 15 months |
| Change from baseline in Eating Behavior assessed by a dietitian from a questionnaire | 15 months |
| Change from baseline in Physical activity and sedentary behavior assessed by the number of hours of physical activity per week | 15 months |
| Glycemia (mmol/l) | Change from baseline in metabolic syndrome | 15 months |
| Fasting insulinemia (µmol/l) | Change from baseline in metabolic syndrome | 15 months |
| Homeostasis Model assessment (HOMA) | Change from baseline in metabolic syndrome | 15 months |
| Dyslipidemia (mmol/l) | Change from baseline in metabolic syndrome | 15 months |
| Blood pressure (mmHg) | Change from baseline in metabolic syndrome | 15 months |
| 26530929 | Background | Svetkey LP, Batch BC, Lin PH, Intille SS, Corsino L, Tyson CC, Bosworth HB, Grambow SC, Voils C, Loria C, Gallis JA, Schwager J, Bennett GG. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology. Obesity (Silver Spring). 2015 Nov;23(11):2133-41. doi: 10.1002/oby.21226. |
| 25760813 | Background | Pretlow RA, Stock CM, Allison S, Roeger L. Treatment of child/adolescent obesity using the addiction model: a smartphone app pilot study. Child Obes. 2015 Jun;11(3):248-59. doi: 10.1089/chi.2014.0124. Epub 2015 Mar 11. |
| 40704768 | Result | Foissac F, Lepage G, Briand N, Cosnefroy M, Charrat A, Dabbas M. Mobile Health Is a Cost-Effective Strategy for Managing Obesity in Adolescents: A Randomised Controlled Trial. Acta Paediatr. 2025 Dec;114(12):3233-3243. doi: 10.1111/apa.70248. Epub 2025 Jul 24. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |