Mobile Health Intervention

Obesity Clinical Trial

— MHI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955017
• Other study ID #: 2016-A00666-45
• Status: Completed
• Phase: N/A
• Start date: November 16, 2016
• Est. completion date: November 13, 2019

Study information

• Verified date: January 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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
• 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

Locations

Country	Name	City	State
France	Necker-Enfants malades Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. Erratum in: Obesity (Silver Spring). 2016 Feb;24(2):536. Bennett, G B [Corrected to Bennett, G G]. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in mean difference of Body Mass Index Z-score between the two groups		15 months
Secondary	Percent of loss to follow-up		15 months
Secondary	Change from baseline in PedsQL score		15 months
Secondary	Change from baseline in Eating Behavior assessed by a dietitian from a questionnaire		15 months
Secondary	Change from baseline in Physical activity and sedentary behavior assessed by the number of hours of physical activity per week		15 months
Secondary	Glycemia (mmol/l)	Change from baseline in metabolic syndrome	15 months
Secondary	Fasting insulinemia (µmol/l)	Change from baseline in metabolic syndrome	15 months
Secondary	Homeostasis Model assessment (HOMA)	Change from baseline in metabolic syndrome	15 months
Secondary	Dyslipidemia (mmol/l)	Change from baseline in metabolic syndrome	15 months
Secondary	Blood pressure (mmHg)	Change from baseline in metabolic syndrome	15 months