Mobile Health Intervention

Assistance Publique - Hôpitaux de Paris91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

traditional follow_upBEHAVIORAL

* 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

distance follow-up "new technologies"BEHAVIORAL

* Multidisciplinary support with long distance monitoring "Mobile apps". * Two days of a complete medical check at 9 and 15 months

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Necker-Enfants malades Hospital

Paris, Paris, France

Outcomes

Primary Outcomes

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

Time frame: 15 months

Secondary Outcomes

Change from baseline in mean difference of Body Mass Index Z-score between the two groups

Time frame: 15 months

Percent of loss to follow-up

Time frame: 15 months

Change from baseline in PedsQL score

Time frame: 15 months

Change from baseline in Eating Behavior assessed by a dietitian from a questionnaire

Time frame: 15 months

Change from baseline in Physical activity and sedentary behavior assessed by the number of hours of physical activity per week

Time frame: 15 months

Glycemia (mmol/l)

Change from baseline in metabolic syndrome

Time frame: 15 months

Fasting insulinemia (µmol/l)

Change from baseline in metabolic syndrome

Time frame: 15 months

Homeostasis Model assessment (HOMA)

Change from baseline in metabolic syndrome

Time frame: 15 months

Dyslipidemia (mmol/l)

Data from ClinicalTrials.gov

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