Quality of Life and Behavioral Change of Retired Persons

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Group nutrition and physical activity coaching; Other: Group cognition coaching

• Registration Number: NCT06432010
• Lead Sponsor: Institut Pasteur de Lille

Brief 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. 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 Timeline

• Study Start: 2021-06-22
• Study First Submitted: 2021-10-11
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-29
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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;.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group nutrition and physical activity coaching	Group nutrition and physical activity coaching	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)
Group cognition coaching	Group cognition coaching	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)

Primary Outcome Measures

Name	Time	Method
Change from baseline on quality of life of retired people 12 months after the end of the coaching sessions.	1 year	Health quality will be evaluated thanks to a health quality questionnary validated by the World Health Organisation (WHO).

Secondary Outcome Measures

Name	Time	Method
Anthropometric parameters (waist circumference)	1 year	- Waist circumference in centimeters
Change from baseline on sleep quality at 1 year after the coaching	1 year	It will be measure with : - Insomnia Severity Index (ISI) to assess sleep quality
Change from baseline on food behavior at 1 year after the coaching	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)
Change from baseline on physical activity behaviors at 1 year after the coaching	1 year	Visual Analog Scales for Behavioral Change Related to Physical Activity raging from 10 (yes really a lot) to 0 (not at all)
Change from baseline on food behaviors at 1 year after the coaching	1 year	Food behaviors will be measure with Balance and dietary diversity questionnaire proposed by the Institut Pasteur de Lille
Change from baseline on physical activity frequency at 1 year after the coaching	1 year	Marshall Questionnaire for Physical Activity frequency and two questions to evaluate the sedentarity livestyle level.
Change from baseline on static balance at 1 year after the coaching	1 year	The using test is : Unipodal balance (static balance) Measured in seconds
Change from baseline on speed at 1 year after the coaching	1 year	The using test is : 4 meters walking speed; Measured in seconds
Change from baseline on dynamic balance at 1 year after the coaching	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
Lipids metabolism	1 year	Blood samples will be collected to analyse: total cholesterol, HDL, LDL, TG
Change from baseline on cognitive performances at 1 year after the coaching	1 year	Cognitive performances will be measure with : - Montreal cognitive assessment test (MOCA test) to evaluate mild cognitive dysfunction
Change from baseline on food frequency at 1 year after the coaching	1 year	Food frequency will be measure with 24-hour reminder of ingestas; - Visual analogue scales on changes in eating behavior.
Change from baseline on stress management at 1 year after the coaching	1 year	It will be measure with : - Cohen's Questionnaire
Change from baseline on physical performances (upper limbs) at 1 year after the coaching	1 year	The using test is : •Arm curl test to calculate the number of arm bend
Body composition (bone mineral density)	1 year	Measurement by DEXA (Dual X Ray Absorptiometry) for half of the total population : - Bone mineral density in grams/cm²
Change from baseline on anxiety at 1 year after the coaching	1 year	It will be measure with : - Hospital Anxiety And Depression Queqtionnaire (HAD questionnaire to assess anxiety and depression)
Change from baseline on physical performances (lower limbs) at 1 year after the coaching	1 year	The using test is : • Stand up chair test to calculate the number of raise on 30 seconds
Change from baseline on flexibility at 1 year after the coaching	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)
Change from baseline on mobility at 1 year after the coaching	1 year	The using test is : Get up and go test Measured by index ranging from 5 (the worst) to 1 (the best)
Body composition	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
Systolic and diastolic blood pressure	1 year	Systolic and diastolic blood pressure to calculate blood pressure
Change from baseline on endurance at 1 year after the coaching	1 year	The using test is : • 6 minutes walk test (endurance) Measured in meters
Change from baseline on memory at 1 year after the coaching	1 year	It will be measure with : - Working Memory Questionnaire
Glucose metabolism	1 year	Blood samples will be collected to analyse fasting blood glucose
Anthropometric parameters (Body Masse Index)	1 year	Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2

Trial Locations

Locations (1)

NutrInvest - Institut Pasteur de Lille; 🇫🇷 Lille, Nord, France