Clinical trial NCT02955017: Mobile Health Intervention
Official title: Use of New Technologies for the Follow-up in Adolescent Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
children
adolescents
new technology
mobile health
chronic disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 91
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Body Mass Index Z-score
timeFrame: 15 months
Secondary outcomes:
measure: Change from baseline in mean difference of Body Mass Index Z-score between the two groups
timeFrame: 15 months
measure: Percent of loss to follow-up
timeFrame: 15 months
measure: Change from baseline in PedsQL score
timeFrame: 15 months
measure: Change from baseline in Eating Behavior assessed by a dietitian from a questionnaire
timeFrame: 15 months
measure: Change from baseline in Physical activity and sedentary behavior assessed by the number of hours of physical activity per week
timeFrame: 15 months
measure: Glycemia (mmol/l)
timeFrame: 15 months
measure: Fasting insulinemia (µmol/l)
timeFrame: 15 months
measure: Homeostasis Model assessment (HOMA)
timeFrame: 15 months
measure: Dyslipidemia (mmol/l)
timeFrame: 15 months
measure: Blood pressure (mmHg)
timeFrame: 15 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker-Enfants malades Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Myriam DABBAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.