Clinical trial NCT03337412: Adapted Physical Activity Study
Official title: Therapeutic Care and Education in Endocrinology-Diabetes-Nutrition: Evaluation of the Interest of the APA Educator (Adapted Physical Activity Educator) for the Establishment of Physical Activities in the Management and Prevention of Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Therapeutic Education
physical activity
overweight
obesity
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: uncontrolled, non-randomized, open-plan, multi-centre study
Primary purpose: PREVENTION

Brief summary: An uncontrolled, non-randomized, open-plan, multi-centre study of treatment and therapeutic education in endocrinology-diabetes-Nutrition that seeks to assess the interest of an adapted physical activity educator for the implementation In place of physical activities in the management and prevention of overweight and obesity. The proposed study seeks to promote the physical activity (PA) to patients and employees, including the encouragement of physical activity in a guided and personalized way, through workshops on working time, and follow-up of the evolution of the PA through a Adapted questionnaire.

Detailed description: The evaluation will be proposed

* in the Department of Endocrinology, Metabolic diseases and Nutrition of the Nantes University Hospital to all patients participating in "overweight education groups" in complete hospitalization or in day hospital
* to the employees of the group Fleury-Michon volunteers.
* During a recruitment period of 6 months required for the recruitment of 100 patients and 80 employees;
* For a total duration of the research for each 1 year participant. Patients and employees will be systematically informed of the project and their consent will be collected by oral and plotted in the medical file and in the employee file, kept by the adapted physical activity educator.

For the hospital phase, patients will be asked to complete questionnaires regarding their physical activity, diet and quality of life prior to hospital care. For an evaluation of the chronological evolution of their physical activity, they will be invited to complete the global Physical Activity Questionnaire (GPAQ 2.0), every 2 months, from their home, via the Internet from a secure link (ECRF clinsight) for the duration of the Research is one year. At 6 months during a telephone contact and at 12 months, during a consultation, the food and quality of life questionnaires will also have to be informed. The evolution of weight, body mass index (BMI) and metabolic biological factors (fasting blood glucose and lipid balance) will also be collected.

For the enterprise phase, employees will benefit from a life-health awareness program, accompanied by an APA educator, they are offered the opportunity to participate in physical activity workshops on a regular basis (12 workshops minimum over 6 months), adapted to their abilities and personalized. They will be invited to fill, from their home or on the website Fleury Michon, via the Internet from a secure link (ECRF clinsight) the same type of questionnaire

Eligibility criteria: Inclusion Criteria:

* Adult Patients hospitalized for weight problem in the service of endocrinology, metabolic diseases and Nutrition of the Nantes University Hospital's and employees of the company Fleury-Michon not contraindicated to the practice of a sports activity by the dealing doctor
* benefiting from the intervention of an APA educator
* able to complete the questionnaires of physical activity, eating habits, quality of life and satisfaction
* having given their oral consent

Exclusion Criteria:

* Major subjects protected, under guardianship or curators;
* Pregnant women on a declarative test

Primary outcomes:
measure: Chronological evolution of the physical activity score of patients benefiting from the education program with intervention of the adapted physical activity educator
timeFrame: every 2 months over 12 months
Secondary outcomes:
measure: Changes in eating habits
timeFrame: at 6 months and 1 year
measure: Evolution of BMI
timeFrame: at 6 months and 1 year
measure: Evolution of the basic energy expenditure
timeFrame: at 12 months
measure: Evolution of metabolic parameters (fasting blood glucose and lipid balance)
timeFrame: at 12 months
measure: Evolution of the quality of life
timeFrame: at 6 months and 1 year
measure: Evolution of patients satisfaction
timeFrame: at 6 months and 1 year
measure: musculoskeletal disorders
timeFrame: at 6 months and 1 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Marie GUILLOUCHE, Dr
role: PRINCIPAL_INVESTIGATOR
References: