APA: Adapted Physical Activity Study

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03337412
Collaborator
(none)
180
1
2
24.5
7.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Adapted physical activity
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
uncontrolled, non-randomized, open-plan, multi-centre studyuncontrolled, non-randomized, open-plan, multi-centre study
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Nov 13, 2017
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Nov 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients

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.

Other: Adapted physical activity
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

Experimental: Employees

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.

Other: Adapted physical activity
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

Outcome Measures

Primary Outcome Measures

  1. Chronological evolution of the physical activity score of patients benefiting from the education program with intervention of the adapted physical activity educator [every 2 months over 12 months]

    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

  1. Changes in eating habits [at 6 months and 1 year]

    simple questionnaire on food groups consumed

  2. Evolution of BMI [at 6 months and 1 year]

  3. Evolution of the basic energy expenditure [at 12 months]

    evaluated by calorimetry or impedance

  4. Evolution of metabolic parameters (fasting blood glucose and lipid balance) [at 12 months]

    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

  5. Evolution of the quality of life [at 6 months and 1 year]

    Short Form 36 (SF36) Questionnaire

  6. Evolution of patients satisfaction [at 6 months and 1 year]

    specific questionaire

  7. musculoskeletal disorders [at 6 months and 1 year]

    For employees will also be evaluated certain specific indicators of occupational diseases such as musculoskeletal disorders.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nantes Nantes France

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Principal Investigator: Marie GUILLOUCHE, Dr, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT03337412
Other Study ID Numbers:
  • RC16_0198
First Posted:
Nov 9, 2017
Last Update Posted:
Dec 3, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2020