ObesityMHINCT02955017
Mobile Health Intervention
A study testing traditional follow_up and distance follow-up "new technologies" in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- traditional follow_up and distance follow-up "new technologies"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2016to 13 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- traditional follow_up, distance follow-up "new technologies"
- Keywords
- obesity, children, adolescents, new technology, mobile health, chronic disease
- Medical subject headings
- Obesity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional follow_upBehavioural
- 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"Behavioural
- Multidisciplinary support with long distance monitoring "Mobile apps".
- Two days of a complete medical check at 9 and 15 months
| Study group | Role | What they receive |
|---|---|---|
| Traditional follow-up | Active comparator | Not described Receives: Behavioral: traditional follow_up |
| Distance follow-up "new technologies" | Experimental | Not described Receives: Behavioral: distance follow-up "new technologies" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Secondary outcomes (10)
Change from baseline in mean difference of Body Mass Index Z-score between the two groups
Measured: 15 months
Percent of loss to follow-up
Measured: 15 months
Change from baseline in PedsQL score
Measured: 15 months
Change from baseline in Eating Behavior assessed by a dietitian from a questionnaire
Measured: 15 months
Change from baseline in Physical activity and sedentary behavior assessed by the number of hours of physical activity per week
Measured: 15 months
Glycemia (mmol/l)
Change from baseline in metabolic syndrome
Measured: 15 months
Fasting insulinemia (µmol/l)
Change from baseline in metabolic syndrome
Measured: 15 months
Homeostasis Model assessment (HOMA)
Change from baseline in metabolic syndrome
Measured: 15 months
Dyslipidemia (mmol/l)
Change from baseline in metabolic syndrome
Measured: 15 months
Blood pressure (mmHg)
Change from baseline in metabolic syndrome
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start16 Nov 2016
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Myriam DABBAS, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955017
- Sponsor's protocol ID
- 2016-A00666-45
- Acronym
- MHI
- Status last verified
- Oct 2025
- First submitted
- 24 Oct 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24485327Turner 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.
PubMed 25641770Svetkey 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.
PubMed 26530929Pretlow 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.
PubMed 25760813Foissac 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.
PubMed 40704768
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of New Technologies for the Follow-up in Adolescent Obesity
- ClinicalTrials.gov ID
- NCT02955017
- Acronym / sponsor ID
- MHI / 2016-A00666-45
- Conditions
- Obesity
- Keywords
- obesity, children, adolescents, new technology, mobile health, chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional follow-up | Active comparator | Behavioral: traditional follow_up |
| Distance follow-up "new technologies" | Experimental | Behavioral: distance follow-up "new technologies" |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Traditional follow-up |
| 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 | Behavioural | Distance follow-up "new technologies" |
Primary outcome
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
10 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)
Time frame: 15 months
Fasting insulinemia (µmol/l)
Time frame: 15 months
Homeostasis Model assessment (HOMA)
Time frame: 15 months
Dyslipidemia (mmol/l)
Time frame: 15 months
Blood pressure (mmHg)
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 24485327O'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.
- Background: PubMed 25641770Turner 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.
- Background: PubMed 26530929Svetkey 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.
- Background: PubMed 25760813Pretlow 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.
- Results publication: PubMed 40704768Foissac 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myriam DABBAS, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional follow_up and distance follow-up "new technologies" in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Body Mass Index Z-score (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02955017, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.