ObesityAPANCT03337412
Adapted Physical Activity Study
A study testing Adapted physical activity in people with Obesity, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2017to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major subjects protected, under guardianship or curators;
- Pregnant women on a declarative test
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Obesity
- Being tested
- Adapted physical activity
- Keywords
- Therapeutic Education, physical activity, overweight, obesity
- Medical subject headings
- Obesity, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted physical activityOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 2 months over 12 months
Secondary outcomes (7)
Changes in eating habits
simple questionnaire on food groups consumed
Measured: at 6 months and 1 year
Evolution of BMI
Measured: at 6 months and 1 year
Evolution of the basic energy expenditure
evaluated by calorimetry or impedance
Measured: at 12 months
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
Measured: at 12 months
Evolution of the quality of life
Short Form 36 (SF36) Questionnaire
Measured: at 6 months and 1 year
Evolution of patients satisfaction
specific questionaire
Measured: at 6 months and 1 year
musculoskeletal disorders
For employees will also be evaluated certain specific indicators of occupational diseases such as musculoskeletal disorders.
Measured: at 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start13 Nov 2017
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- uncontrolled, non-randomized, open-plan, multi-centre study
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie GUILLOUCHE, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337412
- Sponsor's protocol ID
- RC16_0198
- Acronym
- APA
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2017
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03337412
- Acronym / sponsor ID
- APA / RC16_0198
- Conditions
- Obesity
- Keywords
- Therapeutic Education, physical activity, overweight, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- uncontrolled, non-randomized, open-plan, multi-centre study
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Adapted physical activityinitial 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. |
| Employees | Experimental | Other: Adapted physical activityinitial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Major subjects protected, under guardianship or curators;
- Pregnant women on a declarative test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted physical activityPatients 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 | Other | Employees, Patients |
Primary outcome
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.
7 secondary outcomes
Changes in eating habits
Time frame: at 6 months and 1 year
Evolution of BMI
Time frame: at 6 months and 1 year
Evolution of the basic energy expenditure
Time frame: at 12 months
Evolution of metabolic parameters (fasting blood glucose and lipid balance)
Time frame: at 12 months
Evolution of the quality of life
Time frame: at 6 months and 1 year
Evolution of patients satisfaction
Time frame: at 6 months and 1 year
musculoskeletal disorders
Time frame: at 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie GUILLOUCHE, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted physical activity in people with Obesity, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.