Mobile Health Intervention (MHI)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Obesity

Treatments: Behavioral: traditional follow_up; Behavioral: distance follow-up "new technologies"

Study type: Interventional

Funder types: Other

Identifiers

NCT02955017

2016-A00666-45

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Traditional follow-up

Active Comparator group

Treatment:

Behavioral: traditional follow_up

Distance follow-up "new technologies"

Experimental group

Treatment:

Behavioral: distance follow-up "new technologies"