Mobile Health Intervention

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: distance follow-up "new technologies"; Behavioral: traditional follow_up

• Registration Number: NCT02955017
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Study Start: 2016-11-16
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distance follow-up "new technologies"	distance follow-up "new technologies"	-
Traditional follow-up	traditional follow_up	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Body Mass Index Z-score	15 months	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

Secondary Outcome Measures

Name	Time	Method
Blood pressure (mmHg)	15 months	Change from baseline in metabolic syndrome
Change from baseline in mean difference of Body Mass Index Z-score between the two groups	15 months
Fasting insulinemia (µmol/l)	15 months	Change from baseline in metabolic syndrome
Change from baseline in Eating Behavior assessed by a dietitian from a questionnaire	15 months
Dyslipidemia (mmol/l)	15 months	Change from baseline in metabolic syndrome
Percent of loss to follow-up	15 months
Change from baseline in PedsQL score	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)	15 months	Change from baseline in metabolic syndrome
Homeostasis Model assessment (HOMA)	15 months	Change from baseline in metabolic syndrome

Trial Locations

Locations (1)

Necker-Enfants malades Hospital; 🇫🇷 Paris, France