Mobile Health Intervention

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Use of New Technologies for the Follow-up in Adolescent Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: traditional follow_up
* Behavioral: distance follow-up new technologies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 11-17 years old Body Mass Index > 97th percentile using French reference Non Syndromic obesity Appropriate understanding of the study Appropriate understanding of french language, and ability in writing and reading Exclusion Criteria: Mental disability, severe and uncontrolled psychiatric disorders. Syndromic obesity, endocrine disorders or drug-induced obesity Other therapeutic: bariatric surgery, medications for weight loss Enrolment in an other therapeutic study

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional follow-up<br> | Behavioral: traditional follow_up<br>* Multidisciplinary support with educational face to face family based intervention at 6, 9 and 12 months after inclusion. Two days of a complete medical check at 9 and 15 months<br>|
| Experimental: Distance follow-up new technologies<br> | Behavioral: distance follow-up new technologies<br>* Multidisciplinary support with long distance monitoring Mobile apps. Two days of a complete medical check at 9 and 15 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, children, adolescents, new technology, mobile health, chronic disease