Quality of Life and Behavioral Change of Retired Persons

Healthy Volunteers Clinical Trial

— R-FORM'  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06432010
• Other study ID #: 2021-A00408-33
• Status: Completed
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: December 21, 2023

Study information

• Verified date: May 2024
• Source: Institut Pasteur de Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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;.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Group nutrition and physical activity coaching
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
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.

Locations

Country	Name	City	State
France	NutrInvest - Institut Pasteur de Lille	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur de Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year
Secondary	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	1 year
Secondary	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.	1 year
Secondary	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)	1 year
Secondary	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)	1 year
Secondary	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.	1 year
Secondary	Change from baseline on endurance at 1 year after the coaching	The using test is : • 6 minutes walk test (endurance) Measured in meters	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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)	1 year
Secondary	Change from baseline on static balance at 1 year after the coaching	The using test is : Unipodal balance (static balance) Measured in seconds	1 year
Secondary	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)	1 year
Secondary	Change from baseline on speed at 1 year after the coaching	The using test is : 4 meters walking speed; Measured in seconds	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	Change from baseline on memory at 1 year after the coaching	It will be measure with : - Working Memory Questionnaire	1 year
Secondary	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	1 year
Secondary	Change from baseline on stress management at 1 year after the coaching	It will be measure with : - Cohen's Questionnaire	1 year
Secondary	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)	1 year
Secondary	Glucose metabolism	Blood samples will be collected to analyse fasting blood glucose	1 year
Secondary	Lipids metabolism	Blood samples will be collected to analyse: total cholesterol, HDL, LDL, TG	1 year
Secondary	Anthropometric parameters (Body Masse Index)	Weight in kilograms and height in meters will be combined to report BMI in kg/m^2	1 year
Secondary	Anthropometric parameters (waist circumference)	- Waist circumference in centimeters	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	Body composition (bone mineral density)	Measurement by DEXA (Dual X Ray Absorptiometry) for half of the total population : - Bone mineral density in grams/cm²	1 year
Secondary	Systolic and diastolic blood pressure	Systolic and diastolic blood pressure to calculate blood pressure	1 year