Healthy VolunteersR-FORM'NCT06432010
Quality of Life and Behavioral Change of Retired Persons
A study testing Group nutrition and physical activity coaching and Group cognition coaching in people with Healthy Volunteers, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
Researchers have found that the first phase of aging, called "frailty", is insidious, silent and slowly progressive. It begins well before the first signs of aging and possibly before retirement age with physiological reserves that are gradually depleted. Frailty is multifactorial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Group nutrition and physical activity coaching and Group cognition coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2021to 21 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Man or Woman;
- Retired;
- Having the desire to change his/her lifestyle;
- Agreeing to follow the constraints generated by the study (presence during the coaching sessions and the final assessment).
- Having signed the informed consent form;
- Social insured;
Who cannot join
- Presenting a pathology requiring a complementary assessment and/or the implementation of a treatment that could prevent the realization of the coaching or that could modify its effect;
- Subject participating in another clinical study or in period of exclusion from another study;
- Subject deprived of liberty;
- Subject under judicial protection measure;
- Whose main investigator or a qualified co-investigator judges that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study;.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Health Check-up Followed by a Collective Coaching on the Quality of Life and Behavioral Change of Retired Persons. A Prospective Study Conducted in Ambulatory.
Researchers have found that the first phase of aging, called "frailty", is insidious, silent and slowly progressive. It begins well before the first signs of aging and possibly before retirement age with physiological reserves that are gradually depleted. Frailty is multifactorial. It is situated between the "robust-vigorous" and "poly-pathological-dependent" stages of aging. This state remains dynamic and above all reversible through screening and awareness of the individual's health determinants as well as motivation to change.
The Longevity Pathway was designed to meet several concrete objectives ranging from improving prevention to advancing research on the topic of longevity and aging well.
This study aims to evaluate the effect of this personalized support on the quality of life of the consultants, but also on many health parameters, 12 months after the end of the proposed coaching.
Read the detailed description
The study will be carried out on healthy volunteers, retired.
The main objective of the study is to evaluate the effect of a health check-up followed by a collective "coaching" type of support on the quality of life of retired people 12 months after the end of the coaching sessions.
- Conditions
- Healthy Volunteers
- Being tested
- Group nutrition and physical activity coaching, Group cognition coaching
- Keywords
- Nutrition and Physical Activity coaching, Cognition coaching, Longevity, Prevention, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group nutrition and physical activity coachingOther
Group nutrition and physical activity coaching consists of an initial health check-up, followed by nutrition and physical activity coaching sessions over 7 weeks, 2 telephone follow-ups at 3 and 6 months and finally a final health check-up, 12 months after the end of the group nutrition and physical activity coaching sessions.
Group cognition coachingOther
Group cognition coaching consists of an initial health check-up, followed by cognition coaching sessions over 7 weeks, 2 telephone follow-ups at 3 and 6 months and finally a final health check-up, 12 months after the end of the cognition coaching sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group nutrition and physical activity coaching | Other | Initial health check-up → 7 weeks nutrition and physical activity coaching → 2 telephone follow-ups at 3 and 6 months after → Final health check-up (12 months after) Receives: Other: Group nutrition and physical activity coaching |
| Group cognition coaching | Other | Initial health check-up → 7 weeks cognition coaching → 2 telephone follow-ups at 3 and 6 months after → Final health check-up (12 months after) Receives: Other: Group cognition coaching |
| control group | No intervention | The study is controlled by the presence of a control group (non-coaching group). 25 people will be included in the control group. They will only benefit from the initial and final health check-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on quality of life of retired people 12 months after the end of the coaching sessions.
Health quality will be evaluated thanks to a health quality questionnary validated by the World Health Organisation (WHO).
Measured: 1 year
Secondary outcomes (26)
Change from baseline on food behaviors at 1 year after the coaching
Food behaviors will be measure with Balance and dietary diversity questionnaire proposed by the Institut Pasteur de Lille
Measured: 1 year
Change from baseline on food frequency at 1 year after the coaching
Food frequency will be measure with 24-hour reminder of ingestas
- Visual analogue scales on changes in eating behavior.
Measured: 1 year
Change from baseline on food behavior at 1 year after the coaching
Food behaviors will be measure with Visual analogue scales on changes in eating behavior from 10 (yes really a lot) to 0 (not at all)
Measured: 1 year
Change from baseline on physical activity behaviors at 1 year after the coaching
Visual Analog Scales for Behavioral Change Related to Physical Activity raging from 10 (yes really a lot) to 0 (not at all)
Measured: 1 year
Change from baseline on physical activity frequency at 1 year after the coaching
Marshall Questionnaire for Physical Activity frequency and two questions to evaluate the sedentarity livestyle level.
Measured: 1 year
Change from baseline on endurance at 1 year after the coaching
The using test is :
- 6 minutes walk test (endurance) Measured in meters
Measured: 1 year
Change from baseline on physical performances (lower limbs) at 1 year after the coaching
The using test is :
- Stand up chair test to calculate the number of raise on 30 seconds
Measured: 1 year
Change from baseline on physical performances (upper limbs) at 1 year after the coaching
The using test is :
•Arm curl test to calculate the number of arm bend
Measured: 1 year
Change from baseline on flexibility at 1 year after the coaching
The using test is :
•Flexible trunk and posterior chain of lower limbs Measured by index ranging from 5 (the palms of the hands touch the ground) to 1 (the fingertips reach the lower shins)
Measured: 1 year
Change from baseline on static balance at 1 year after the coaching
The using test is :
Unipodal balance (static balance) Measured in seconds
Measured: 1 year
Change from baseline on mobility at 1 year after the coaching
The using test is :
Get up and go test Measured by index ranging from 5 (the worst) to 1 (the best)
Measured: 1 year
Change from baseline on speed at 1 year after the coaching
The using test is :
4 meters walking speed
Measured in seconds
Measured: 1 year
Change from baseline on dynamic balance at 1 year after the coaching
The using test is :
2 minutes on the spot knee climb This test explores the muscular strength of the lower limbs, dynamic balance and walking Measured in number of knee climb in 2 minutes
Measured: 1 year
Change from baseline on cognitive performances at 1 year after the coaching
Cognitive performances will be measure with :
- Montreal cognitive assessment test (MOCA test) to evaluate mild cognitive dysfunction
Measured: 1 year
Change from baseline on memory at 1 year after the coaching
It will be measure with :
- Working Memory Questionnaire
Measured: 1 year
Change from baseline on sleep quality at 1 year after the coaching
It will be measure with :
- Insomnia Severity Index (ISI) to assess sleep quality
Measured: 1 year
Change from baseline on stress management at 1 year after the coaching
It will be measure with :
- Cohen's Questionnaire
Measured: 1 year
Change from baseline on anxiety at 1 year after the coaching
It will be measure with :
- Hospital Anxiety And Depression Queqtionnaire (HAD questionnaire to assess anxiety and depression)
Measured: 1 year
Glucose metabolism
Blood samples will be collected to analyse fasting blood glucose
Measured: 1 year
Lipids metabolism
Blood samples will be collected to analyse: total cholesterol, HDL, LDL, TG
Measured: 1 year
Anthropometric parameters (Body Masse Index)
Weight in kilograms and height in meters will be combined to report BMI in kg/m^2
Measured: 1 year
Anthropometric parameters (waist circumference)
- Waist circumference in centimeters
Measured: 1 year
Body composition
Measurement of body fat by DEXA (Dual X Ray Absorptiometry) for half of the total population :
- Body fat in grams
- Lean mass in grams
- Total mass in grams
- Visceral fat mass in grams
- subcutaneous fat mass in grams
- Bone mineral content in grams
Measured: 1 year
Body composition
Measurement of lean mass by DEXA (Dual X Ray Absorptiometry) for half of the total population :
- Body fat in percentage
- Lean mass in percentage
- Visceral fat mass in percentage
- subcutaneous fat mass in percentage
Measured: 1 year
Body composition (bone mineral density)
Measurement by DEXA (Dual X Ray Absorptiometry) for half of the total population :
- Bone mineral density in grams/cm²
Measured: 1 year
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure to calculate blood pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start22 Jun 2021
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Exploratory prospective, monocentric, ambulatory study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel LECERF, MD, Principal investigator, Institut Pasteur de Lille - NutrInvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432010
- Sponsor's protocol ID
- 2021-A00408-33
- Acronym
- R-FORM'
- Status last verified
- May 2024
- First submitted
- 11 Oct 2021
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Health Check-up Followed by a Collective Coaching on the Quality of Life and Behavioral Change of Retired Persons. A Prospective Study Conducted in Ambulatory.
- ClinicalTrials.gov ID
- NCT06432010
- Acronym / sponsor ID
- R-FORM' / 2021-A00408-33
- Conditions
- Healthy Volunteers
- Keywords
- Nutrition and Physical Activity coaching, Cognition coaching, Longevity, Prevention, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 29 May 2024 (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.
Researchers have found that the first phase of aging, called "frailty", is insidious, silent and slowly progressive. It begins well before the first signs of aging and possibly before retirement age with physiological reserves that are gradually depleted. Frailty is multifactorial. It is situated between the "robust-vigorous" and "poly-pathological-dependent" stages of aging. This state remains dynamic and above all reversible through screening and awareness of the individual's health determinants as well as motivation to change.
The Longevity Pathway was designed to meet several concrete objectives ranging from improving prevention to advancing research on the topic of longevity and aging well.
This study aims to evaluate the effect of this personalized support on the quality of life of the consultants, but also on many health parameters, 12 months after the end of the proposed coaching.
Detailed description
The study will be carried out on healthy volunteers, retired.
The main objective of the study is to evaluate the effect of a health check-up followed by a collective "coaching" type of support on the quality of life of retired people 12 months after the end of the coaching sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Exploratory prospective, monocentric, ambulatory study
| Arm | Type | Receives |
|---|---|---|
| Group nutrition and physical activity coaching | Other | Other: Group nutrition and physical activity coachingInitial health check-up → 7 weeks nutrition and physical activity coaching → 2 telephone follow-ups at 3 and 6 months after → Final health check-up (12 months after) |
| Group cognition coaching | Other | Other: Group cognition coachingInitial health check-up → 7 weeks cognition coaching → 2 telephone follow-ups at 3 and 6 months after → Final health check-up (12 months after) |
| control group | No intervention | –The study is controlled by the presence of a control group (non-coaching group). 25 people will be included in the control group. They will only benefit from the initial and final health check-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Man or Woman;
- Retired;
- Having the desire to change his/her lifestyle;
- Agreeing to follow the constraints generated by the study (presence during the coaching sessions and the final assessment).
- Having signed the informed consent form;
Key exclusion criteria (5 listed)
- Presenting a pathology requiring a complementary assessment and/or the implementation of a treatment that could prevent the realization of the coaching or that could modify its effect;
- Subject participating in another clinical study or in period of exclusion from another study;
- Subject deprived of liberty;
- Subject under judicial protection measure;
- Whose main investigator or a qualified co-investigator judges that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study;.
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 |
|---|---|---|
| Group nutrition and physical activity coachingGroup nutrition and physical activity coaching consists of an initial health check-up, followed by nutrition and physical activity coaching sessions over 7 weeks, 2 telephone follow-ups at 3 and 6 months and finally a final health check-up, 12 months after the end of the group nutrition and physical activity coaching sessions. | Other | Group nutrition and physical activity coaching |
| Group cognition coachingGroup cognition coaching consists of an initial health check-up, followed by cognition coaching sessions over 7 weeks, 2 telephone follow-ups at 3 and 6 months and finally a final health check-up, 12 months after the end of the cognition coaching sessions. | Other | Group cognition coaching |
Primary outcome
Change from baseline on quality of life of retired people 12 months after the end of the coaching sessions.
Time frame: 1 year
Health quality will be evaluated thanks to a health quality questionnary validated by the World Health Organisation (WHO).
26 secondary outcomes
Change from baseline on food behaviors at 1 year after the coaching
Time frame: 1 year
Change from baseline on food frequency at 1 year after the coaching
Time frame: 1 year
Change from baseline on food behavior at 1 year after the coaching
Time frame: 1 year
Change from baseline on physical activity behaviors at 1 year after the coaching
Time frame: 1 year
Change from baseline on physical activity frequency at 1 year after the coaching
Time frame: 1 year
Change from baseline on endurance at 1 year after the coaching
Time frame: 1 year
Change from baseline on physical performances (lower limbs) at 1 year after the coaching
Time frame: 1 year
Change from baseline on physical performances (upper limbs) at 1 year after the coaching
Time frame: 1 year
Change from baseline on flexibility at 1 year after the coaching
Time frame: 1 year
Change from baseline on static balance at 1 year after the coaching
Time frame: 1 year
Change from baseline on mobility at 1 year after the coaching
Time frame: 1 year
Change from baseline on speed at 1 year after the coaching
Time frame: 1 year
Change from baseline on dynamic balance at 1 year after the coaching
Time frame: 1 year
Change from baseline on cognitive performances at 1 year after the coaching
Time frame: 1 year
Change from baseline on memory at 1 year after the coaching
Time frame: 1 year
Change from baseline on sleep quality at 1 year after the coaching
Time frame: 1 year
Change from baseline on stress management at 1 year after the coaching
Time frame: 1 year
Change from baseline on anxiety at 1 year after the coaching
Time frame: 1 year
Glucose metabolism
Time frame: 1 year
Lipids metabolism
Time frame: 1 year
Anthropometric parameters (Body Masse Index)
Time frame: 1 year
Anthropometric parameters (waist circumference)
Time frame: 1 year
Body composition
Time frame: 1 year
Body composition
Time frame: 1 year
Body composition (bone mineral density)
Time frame: 1 year
Systolic and diastolic blood pressure
Time frame: 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 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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.
Jean-Michel LECERF, MD principal investigator
Institut Pasteur de Lille - NutrInvest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group nutrition and physical activity coaching and Group cognition coaching in people with Healthy Volunteers, run by Institut Pasteur de Lille 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 6 inclusion and 5 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 Jun 2024. 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?
Change from baseline on quality of life of retired people 12 months after the end of the coaching sessions. (time frame: 1 year). 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 Jun 2024.