Adapted Physical Activity Study

NCT03337412 | Completed

• 1 other identifier: RC16_0198
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Therapeutic Education; physical activity; overweight; obesity

Outcome Measures

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

  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 Outcomes (7)

• Changes in eating habits

  at 6 months and 1 year

• Evolution of BMI

  at 6 months and 1 year

• Evolution of the basic energy expenditure

  at 12 months

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

  at 12 months

• Evolution of the quality of life

  at 6 months and 1 year

Study Arms (2)

Patients

EXPERIMENTAL

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

Employees

EXPERIMENTAL

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

Interventions

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

Employees; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marie GUILLOUCHE, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: uncontrolled, non-randomized, open-plan, multi-centre study

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 9, 2017
• Study Start: November 13, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)