Adapted Physical Activity Study

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337412
• Other study ID #: RC16_0198
• Status: Completed
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: November 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every 2 months over 12 months
Secondary	Changes in eating habits	simple questionnaire on food groups consumed	at 6 months and 1 year
Secondary	Evolution of BMI		at 6 months and 1 year
Secondary	Evolution of the basic energy expenditure	evaluated by calorimetry or impedance	at 12 months
Secondary	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	at 12 months
Secondary	Evolution of the quality of life	Short Form 36 (SF36) Questionnaire	at 6 months and 1 year
Secondary	Evolution of patients satisfaction	specific questionaire	at 6 months and 1 year
Secondary	musculoskeletal disorders	For employees will also be evaluated certain specific indicators of occupational diseases such as musculoskeletal disorders.	at 6 months and 1 year