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Adapted Physical Activity Study (APA)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted physical activity
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Therapeutic Education, physical activity, overweight, obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients

Employees

Arm Description

initial assessment of physical capacities, determination of personalized objectives on the occasion of 1 to 2 workshops during the hospital checkup. Telephone Contact by the APA educator at 6 months. One-year medical visit.

initial assessment of physical capacities, participation in 10 to 20 physical activity workshops over 6 months on working time, then employees oriented towards autonomous activities over the following 6 months. Evaluation by computer-filled questionnaires.

Outcomes

Primary Outcome Measures

Chronological evolution of the physical activity score of patients benefiting from the education program with intervention of the adapted physical activity educator
Physical activity will be evaluated both qualitatively (low, moderate and intense) and quantitatively (expressed as metabolic Equivalent of Task: MET-min/week) through the World Health Organization GPAQ 2.0 questionnaire, based on physical activities at work, In moving and hobbies.

Secondary Outcome Measures

Changes in eating habits
simple questionnaire on food groups consumed
Evolution of BMI
Evolution of the basic energy expenditure
evaluated by calorimetry or impedance
Evolution of metabolic parameters (fasting blood glucose and lipid balance)
fasting blood glucose and lipid balance are measured systematically for patients with hospital care, and are optional according to the biological balances already performed for the employees
Evolution of the quality of life
Short Form 36 (SF36) Questionnaire
Evolution of patients satisfaction
specific questionaire
musculoskeletal disorders
For employees will also be evaluated certain specific indicators of occupational diseases such as musculoskeletal disorders.

Full Information

First Posted
October 26, 2017
Last Updated
December 1, 2020
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03337412
Brief Title
Adapted Physical Activity Study
Acronym
APA
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Therapeutic Education, physical activity, overweight, obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
uncontrolled, non-randomized, open-plan, multi-centre study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
initial assessment of physical capacities, determination of personalized objectives on the occasion of 1 to 2 workshops during the hospital checkup. Telephone Contact by the APA educator at 6 months. One-year medical visit.
Arm Title
Employees
Arm Type
Experimental
Arm Description
initial assessment of physical capacities, participation in 10 to 20 physical activity workshops over 6 months on working time, then employees oriented towards autonomous activities over the following 6 months. Evaluation by computer-filled questionnaires.
Intervention Type
Other
Intervention Name(s)
Adapted physical activity
Intervention Description
Patients will be asked to complete questionnaires about 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 Physical Activity Questionnaire GPAQ 2.0 every 2 months, for the duration of the Research.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 and metabolic biological factors will also be collected. 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, the same type of questionnaire
Primary Outcome Measure Information:
Title
Chronological evolution of the physical activity score of patients benefiting from the education program with intervention of the adapted physical activity educator
Description
Physical activity will be evaluated both qualitatively (low, moderate and intense) and quantitatively (expressed as metabolic Equivalent of Task: MET-min/week) through the World Health Organization GPAQ 2.0 questionnaire, based on physical activities at work, In moving and hobbies.
Time Frame
every 2 months over 12 months
Secondary Outcome Measure Information:
Title
Changes in eating habits
Description
simple questionnaire on food groups consumed
Time Frame
at 6 months and 1 year
Title
Evolution of BMI
Time Frame
at 6 months and 1 year
Title
Evolution of the basic energy expenditure
Description
evaluated by calorimetry or impedance
Time Frame
at 12 months
Title
Evolution of metabolic parameters (fasting blood glucose and lipid balance)
Description
fasting blood glucose and lipid balance are measured systematically for patients with hospital care, and are optional according to the biological balances already performed for the employees
Time Frame
at 12 months
Title
Evolution of the quality of life
Description
Short Form 36 (SF36) Questionnaire
Time Frame
at 6 months and 1 year
Title
Evolution of patients satisfaction
Description
specific questionaire
Time Frame
at 6 months and 1 year
Title
musculoskeletal disorders
Description
For employees will also be evaluated certain specific indicators of occupational diseases such as musculoskeletal disorders.
Time Frame
at 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie GUILLOUCHE, Dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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