## Protocol Section
### Identification Module
**NCT ID:** NCT06432010

**Acronym:** R-FORM'

**Brief Title:** Quality of Life and Behavioral Change of Retired Persons

**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.

#### Organization Study ID Info
**ID:** 2021-A00408-33
#### Organization
**Class:** OTHER
**Full Name:** Institut Pasteur de Lille
### Status Module
#### Completion Date
**Date:** 2023-12-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-21

**Type:** ACTUAL

#### Start Date
**Date:** 2021-06-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2021-10-11
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Institut Pasteur de Lille

#### Responsible Party

**Investigator Affiliation:** Institut Pasteur de Lille

**Investigator Full Name:** Jean-Michel Lecerf

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy Volunteers

**Keywords:**

- Nutrition and Physical Activity coaching

- Cognition coaching

- Longevity

- Prevention

- Quality of life

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Exploratory prospective, monocentric, ambulatory study

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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)

**Intervention Names:**

- Other: Group nutrition and physical activity coaching

**Label:** Group nutrition and physical activity coaching

**Type:** OTHER

#### Arm Group 2

**Description:** 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)

**Intervention Names:**

- Other: Group cognition coaching

**Label:** Group cognition coaching

**Type:** OTHER

#### Arm Group 3

**Description:** 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.

**Label:** control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group nutrition and physical activity coaching

**Description:** 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.

**Name:** Group nutrition and physical activity coaching

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Group cognition coaching

**Description:** 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.

**Name:** Group cognition coaching

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Health quality will be evaluated thanks to a health quality questionnary validated by the World Health Organisation (WHO).

**Measure:** Change from baseline on quality of life of retired people 12 months after the end of the coaching sessions.

**Time Frame:** 1 year

#### Secondary Outcomes

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

**Measure:** Change from baseline on food behaviors at 1 year after the coaching

**Time Frame:** 1 year

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

- Visual analogue scales on changes in eating behavior.

**Measure:** Change from baseline on food frequency at 1 year after the coaching

**Time Frame:** 1 year

**Description:** 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)

**Measure:** Change from baseline on food behavior at 1 year after the coaching

**Time Frame:** 1 year

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

**Measure:** Change from baseline on physical activity behaviors at 1 year after the coaching

**Time Frame:** 1 year

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

**Measure:** Change from baseline on physical activity frequency at 1 year after the coaching

**Time Frame:** 1 year

**Description:** The using test is :

• 6 minutes walk test (endurance) Measured in meters

**Measure:** Change from baseline on endurance at 1 year after the coaching

**Time Frame:** 1 year

**Description:** The using test is :

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

**Measure:** Change from baseline on physical performances (lower limbs) at 1 year after the coaching

**Time Frame:** 1 year

**Description:** The using test is :

•Arm curl test to calculate the number of arm bend

**Measure:** Change from baseline on physical performances (upper limbs) at 1 year after the coaching

**Time Frame:** 1 year

**Description:** 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)

**Measure:** Change from baseline on flexibility at 1 year after the coaching

**Time Frame:** 1 year

**Description:** The using test is :

Unipodal balance (static balance) Measured in seconds

**Measure:** Change from baseline on static balance at 1 year after the coaching

**Time Frame:** 1 year

**Description:** The using test is :

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

**Measure:** Change from baseline on mobility at 1 year after the coaching

**Time Frame:** 1 year

**Description:** The using test is :

4 meters walking speed

Measured in seconds

**Measure:** Change from baseline on speed at 1 year after the coaching

**Time Frame:** 1 year

**Description:** 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

**Measure:** Change from baseline on dynamic balance at 1 year after the coaching

**Time Frame:** 1 year

**Description:** Cognitive performances will be measure with :

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

**Measure:** Change from baseline on cognitive performances at 1 year after the coaching

**Time Frame:** 1 year

**Description:** It will be measure with :

- Working Memory Questionnaire

**Measure:** Change from baseline on memory at 1 year after the coaching

**Time Frame:** 1 year

**Description:** It will be measure with :

- Insomnia Severity Index (ISI) to assess sleep quality

**Measure:** Change from baseline on sleep quality at 1 year after the coaching

**Time Frame:** 1 year

**Description:** It will be measure with :

- Cohen's Questionnaire

**Measure:** Change from baseline on stress management at 1 year after the coaching

**Time Frame:** 1 year

**Description:** It will be measure with :

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

**Measure:** Change from baseline on anxiety at 1 year after the coaching

**Time Frame:** 1 year

**Description:** Blood samples will be collected to analyse fasting blood glucose

**Measure:** Glucose metabolism

**Time Frame:** 1 year

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

**Measure:** Lipids metabolism

**Time Frame:** 1 year

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

**Measure:** Anthropometric parameters (Body Masse Index)

**Time Frame:** 1 year

**Description:** - Waist circumference in centimeters

**Measure:** Anthropometric parameters (waist circumference)

**Time Frame:** 1 year

**Description:** 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

**Measure:** Body composition

**Time Frame:** 1 year

**Description:** 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

**Measure:** Body composition

**Time Frame:** 1 year

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

- Bone mineral density in grams/cm²

**Measure:** Body composition (bone mineral density)

**Time Frame:** 1 year

**Description:** Systolic and diastolic blood pressure to calculate blood pressure

**Measure:** Systolic and diastolic blood pressure

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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;.

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lille

**Country:** France

**Facility:** NutrInvest - Institut Pasteur de Lille

**State:** Nord

**Zip:** 59019

#### Overall Officials

**Official 1:**

**Affiliation:** Institut Pasteur de Lille - NutrInvest

**Name:** Jean-Michel LECERF, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Misc Info Module

- Version Holder: 2024-05-31
