NCT06432010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

October 11, 2021

Last Update Submit

May 31, 2024

Conditions

Keywords

Nutrition and Physical Activity coachingCognition coachingLongevityPreventionQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (26)

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

    1 year

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

    1 year

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

    1 year

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

    1 year

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

    1 year

  • +21 more secondary outcomes

Study Arms (3)

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)

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)

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.

Interventions

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 nutrition and physical activity 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.

Group cognition coaching

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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 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;.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Location

Study Officials

  • Jean-Michel LECERF, MD

    Institut Pasteur de Lille - NutrInvest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Exploratory prospective, monocentric, ambulatory study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 11, 2021

First Posted

May 29, 2024

Study Start

June 22, 2021

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations