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Completed

NCT Number: NCT02955017

Mobile Health Intervention

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.

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Key information

Conditions

Obesity Body Weight Chronic Disease Disease Attributes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker-Enfants malades Hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traditional follow_up

Behavioral
  • 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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 15 months

  2. Percent of loss to follow-up

    Time frame: 15 months

  3. Change from baseline in PedsQL score

    Time frame: 15 months

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

    Time frame: 15 months

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

    Time frame: 15 months

  6. Glycemia (mmol/l)

    Time frame: 15 months

    Change from baseline in metabolic syndrome

  7. Fasting insulinemia (µmol/l)

    Time frame: 15 months

    Change from baseline in metabolic syndrome

  8. Homeostasis Model assessment (HOMA)

    Time frame: 15 months

    Change from baseline in metabolic syndrome

  9. Dyslipidemia (mmol/l)

    Time frame: 15 months

    Change from baseline in metabolic syndrome

  10. Blood pressure (mmHg)

    Time frame: 15 months

    Change from baseline in metabolic syndrome

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: MHI

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2016
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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