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Completed

NCT Number: NCT03337412

Adapted Physical Activity Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adapted physical activity

Other

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 outcomes

  1. Chronological evolution of the physical activity score of patients benefiting from the education program with intervention of the adapted physical activity educator

    Time frame: 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 outcomes

  1. Changes in eating habits

    Time frame: at 6 months and 1 year

    simple questionnaire on food groups consumed

  2. Evolution of BMI

    Time frame: at 6 months and 1 year

  3. Evolution of the basic energy expenditure

    Time frame: at 12 months

    evaluated by calorimetry or impedance

  4. Evolution of metabolic parameters (fasting blood glucose and lipid balance)

    Time frame: 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

    Time frame: at 6 months and 1 year

    Short Form 36 (SF36) Questionnaire

  6. Evolution of patients satisfaction

    Time frame: at 6 months and 1 year

    specific questionaire

  7. musculoskeletal disorders

    Time frame: at 6 months and 1 year

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: APA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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