Mobile Health Intervention

NCT02955017 | Completed

• 1 other identifier: 2016-A00666-45
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; children; adolescents; new technology; mobile health; chronic disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

Traditional follow-up

ACTIVE COMPARATOR

Behavioral: traditional follow_up

Distance follow-up "new technologies"

EXPERIMENTAL

Behavioral: distance follow-up "new technologies"

Interventions

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

Traditional follow-up

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

Distance follow-up "new technologies"

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker-Enfants malades Hospital

Paris, Paris, 75015, France

Location

Related Publications (5)

• O'Malley G, Clarke M, Burls A, Murphy S, Murphy N, Perry IJ. A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial. Trials. 2014 Jan 31;15:43. doi: 10.1186/1745-6215-15-43.

  PMID: 24485327 BACKGROUND

• Turner T, Spruijt-Metz D, Wen CK, Hingle MD. Prevention and treatment of pediatric obesity using mobile and wireless technologies: a systematic review. Pediatr Obes. 2015 Dec;10(6):403-9. doi: 10.1111/ijpo.12002. Epub 2015 Jan 12.

  PMID: 25641770 BACKGROUND

• Svetkey LP, Batch BC, Lin PH, Intille SS, Corsino L, Tyson CC, Bosworth HB, Grambow SC, Voils C, Loria C, Gallis JA, Schwager J, Bennett GG. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology. Obesity (Silver Spring). 2015 Nov;23(11):2133-41. doi: 10.1002/oby.21226.

  PMID: 26530929 BACKGROUND

• Pretlow RA, Stock CM, Allison S, Roeger L. Treatment of child/adolescent obesity using the addiction model: a smartphone app pilot study. Child Obes. 2015 Jun;11(3):248-59. doi: 10.1089/chi.2014.0124. Epub 2015 Mar 11.

  PMID: 25760813 BACKGROUND

• Foissac F, Lepage G, Briand N, Cosnefroy M, Charrat A, Dabbas M. Mobile Health Is a Cost-Effective Strategy for Managing Obesity in Adolescents: A Randomised Controlled Trial. Acta Paediatr. 2025 Dec;114(12):3233-3243. doi: 10.1111/apa.70248. Epub 2025 Jul 24.

  PMID: 40704768 RESULT

MeSH Terms

Conditions

Obesity; Chronic Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Myriam DABBAS, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 4, 2016
• Study Start: November 16, 2016
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)