Mobile Health Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-16

Study Completion Date

2019-11-13

Brief Summary

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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.

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Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Traditional follow-up

Group Type ACTIVE_COMPARATOR

traditional follow_up

Intervention Type 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

Distance follow-up "new technologies"

Group Type EXPERIMENTAL

distance follow-up "new technologies"

Intervention Type BEHAVIORAL

* Multidisciplinary support with long distance monitoring "Mobile apps".
* Two days of a complete medical check at 9 and 15 months

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No