ClinicalTrials.gg
CompletedNCT03337412APAUpdated Dec 3, 2020

Adapted Physical Activity Study

An interventional study of Adapted physical activity in Obesity, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-03.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Obesity by Nantes University Hospital — 5 open to participants now, 5 under way, none of them phase 3. Obesity · Nantes University Hospital.

Started
2017
with 1 other
No phase
8 of 10
3 open now
Registered
5th of 10
by date

Among the 10 studies in Obesity by Nantes University Hospital, this one is one of 2 that started in 2017, is one of 8 with no phase, and was the 5th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

5 of the 10 studies in Obesity by Nantes University Hospital are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Obesity by Nantes University Hospital, or all of them as a file.
02

Study 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.

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

03

Conditions studied

  • Obesity

Keywords

  • Therapeutic Education
  • physical activity
  • overweight
  • obesity
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Major subjects protected, under guardianship or curators;
  • Pregnant women on a declarative test
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherAdapted 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

06

What researchers measure

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.

    Time frame: every 2 months over 12 months

Secondary outcomes

  1. Changes in eating habits

    simple questionnaire on food groups consumed

    Time frame: at 6 months and 1 year

  2. Evolution of BMI

    Time frame: at 6 months and 1 year

  3. Evolution of the basic energy expenditure

    evaluated by calorimetry or impedance

    Time frame: at 12 months

  4. 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

    Time frame: at 12 months

  5. Evolution of the quality of life

    Short Form 36 (SF36) Questionnaire

    Time frame: at 6 months and 1 year

  6. Evolution of patients satisfaction

    specific questionaire

    Time frame: at 6 months and 1 year

  7. musculoskeletal disorders

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

    Time frame: at 6 months and 1 year

07

Study locations

1 site
  • CHU de Nantes
    Nantes, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Nov 2019, 24 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 24 months is close to that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Nov 9, 2017
StartActual
Nov 13, 2017
Primary completionActual
Nov 30, 2019
CompletionActual
Nov 30, 2019
Last update
Dec 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03337412
Responsible party
Sponsor
First posted
Nov 9, 2017
Start date
Nov 13, 2017
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019
Last update
Dec 3, 2020

Study contacts

Marie GUILLOUCHE, Dr
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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