Mobile Health Intervention (MHI)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Paris
      • Paris, Paris, France, 75015
        • Necker-Enfants Malades Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional follow-up
Behavioral: traditional follow_up
  • 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
Experimental: Distance follow-up "new technologies"
Behavioral: distance follow-up "new technologies"
  • Multidisciplinary support with long distance monitoring "Mobile apps".
  • Two days of a complete medical check at 9 and 15 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Body Mass Index Z-score
Time Frame: 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
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
Time Frame: 15 months
15 months
Percent of loss to follow-up
Time Frame: 15 months
15 months
Change from baseline in PedsQL score
Time Frame: 15 months
15 months
Change from baseline in Eating Behavior assessed by a dietitian from a questionnaire
Time Frame: 15 months
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
15 months
Glycemia (mmol/l)
Time Frame: 15 months
Change from baseline in metabolic syndrome
15 months
Fasting insulinemia (µmol/l)
Time Frame: 15 months
Change from baseline in metabolic syndrome
15 months
Homeostasis Model assessment (HOMA)
Time Frame: 15 months
Change from baseline in metabolic syndrome
15 months
Dyslipidemia (mmol/l)
Time Frame: 15 months
Change from baseline in metabolic syndrome
15 months
Blood pressure (mmHg)
Time Frame: 15 months
Change from baseline in metabolic syndrome
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Myriam DABBAS, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2016

Primary Completion (Actual)

November 13, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimated)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00666-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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