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Completed

NCT Number: NCT06432010

Quality of Life and Behavioral Change of Retired Persons

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.

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Key information

Conditions

Healthy Volunteers

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;.

Treatment and study plan

Group nutrition and physical activity coaching

Other

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 coaching

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change from baseline on food behaviors at 1 year after the coaching

    Time frame: 1 year

    Food behaviors will be measure with Balance and dietary diversity questionnaire proposed by the Institut Pasteur de Lille

  2. Change from baseline on food frequency at 1 year after the coaching

    Time frame: 1 year

    Food frequency will be measure with 24-hour reminder of ingestas

    • Visual analogue scales on changes in eating behavior.

  3. Change from baseline on food behavior at 1 year after the coaching

    Time frame: 1 year

    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)

  4. Change from baseline on physical activity behaviors at 1 year after the coaching

    Time frame: 1 year

    Visual Analog Scales for Behavioral Change Related to Physical Activity raging from 10 (yes really a lot) to 0 (not at all)

  5. Change from baseline on physical activity frequency at 1 year after the coaching

    Time frame: 1 year

    Marshall Questionnaire for Physical Activity frequency and two questions to evaluate the sedentarity livestyle level.

  6. Change from baseline on endurance at 1 year after the coaching

    Time frame: 1 year

    The using test is :

    • 6 minutes walk test (endurance) Measured in meters

  7. Change from baseline on physical performances (lower limbs) at 1 year after the coaching

    Time frame: 1 year

    The using test is :

    • Stand up chair test to calculate the number of raise on 30 seconds

  8. Change from baseline on physical performances (upper limbs) at 1 year after the coaching

    Time frame: 1 year

    The using test is :

    •Arm curl test to calculate the number of arm bend

  9. Change from baseline on flexibility at 1 year after the coaching

    Time frame: 1 year

    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)

  10. Change from baseline on static balance at 1 year after the coaching

    Time frame: 1 year

    The using test is :

    Unipodal balance (static balance) Measured in seconds

  11. Change from baseline on mobility at 1 year after the coaching

    Time frame: 1 year

    The using test is :

    Get up and go test Measured by index ranging from 5 (the worst) to 1 (the best)

  12. Change from baseline on speed at 1 year after the coaching

    Time frame: 1 year

    The using test is :

    4 meters walking speed

    Measured in seconds

  13. Change from baseline on dynamic balance at 1 year after the coaching

    Time frame: 1 year

    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

  14. Change from baseline on cognitive performances at 1 year after the coaching

    Time frame: 1 year

    Cognitive performances will be measure with :

    • Montreal cognitive assessment test (MOCA test) to evaluate mild cognitive dysfunction

  15. Change from baseline on memory at 1 year after the coaching

    Time frame: 1 year

    It will be measure with :

    • Working Memory Questionnaire

  16. Change from baseline on sleep quality at 1 year after the coaching

    Time frame: 1 year

    It will be measure with :

    • Insomnia Severity Index (ISI) to assess sleep quality

  17. Change from baseline on stress management at 1 year after the coaching

    Time frame: 1 year

    It will be measure with :

    • Cohen's Questionnaire

  18. Change from baseline on anxiety at 1 year after the coaching

    Time frame: 1 year

    It will be measure with :

    • Hospital Anxiety And Depression Queqtionnaire (HAD questionnaire to assess anxiety and depression)

  19. Glucose metabolism

    Time frame: 1 year

    Blood samples will be collected to analyse fasting blood glucose

  20. Lipids metabolism

    Time frame: 1 year

    Blood samples will be collected to analyse: total cholesterol, HDL, LDL, TG

  21. Anthropometric parameters (Body Masse Index)

    Time frame: 1 year

    Weight in kilograms and height in meters will be combined to report BMI in kg/m^2

  22. Anthropometric parameters (waist circumference)

    Time frame: 1 year

    • Waist circumference in centimeters

  23. Body composition

    Time frame: 1 year

    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

  24. Body composition

    Time frame: 1 year

    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

  25. Body composition (bone mineral density)

    Time frame: 1 year

    Measurement by DEXA (Dual X Ray Absorptiometry) for half of the total population :

    • Bone mineral density in grams/cm²

  26. Systolic and diastolic blood pressure

    Time frame: 1 year

    Systolic and diastolic blood pressure to calculate blood pressure

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Lille

Other

Registry information

Official study 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.

Acronym: R-FORM'

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 29, 2024
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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