NCT07582406

Brief Summary

The benefits of physical activity are well-established. However, adherence to and sustained participation remain limited. These difficulties are partly explained by a lack of consideration for individual differences and the psychosocial factors influencing motivation and participation. Models from the psychology of motivation, such as the transtheoretical model of change, emphasize the importance of support tailored to each individual's level of commitment and personal needs. From this perspective, social design, based on co-creation and the active participation of users, could be a promising approach for individualizing interventions with defined, sustainable, and replicable methodologies. By involving seniors in the design and adjustment of programs, this approach promotes autonomy, a sense of competence, and long-term continuity of practice. Thus, the objective of this study is to determine the effects of co-created physical activity programs with participants on program adherence and long-term physical activity adoption. The hypothesis is that co-created physical activity would lead to better adherence and long-term commitment.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2028

First Submitted

Initial submission to the registry

April 8, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2028

Last Updated

May 12, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 8, 2026

Last Update Submit

May 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Maintenance of physical activity

    Maintenance of physical activity corresponds to the physical activity levels at 6 months and 1 year post-program. It will be measured by the Dijon questionnaire which is a self-administered questionnaire, comprising 9 items assessing the frequency, duration and intensity of physical activities carried out in daily life and leisure.

    6 months and 1 year after the end of the intervention (T2, T3)

  • Adherence of physical activity program

    Adherence corresponds to attendance rates at physical activity sessions during the program.

    Through intervention completion, for 12 weeks.

Secondary Outcomes (10)

  • Stages of behavior change according to the transtheoretical model of behavior change

    Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)

  • Change process according to the transtheoretical model of behavior change

    Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)

  • Decisionnal balance according to the transtheoretical model of behavior change

    Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)

  • Self-efficacy according to the transtheoretical model of behavior change

    Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)

  • Body composition

    Before the intervention (T0) and at the end of the intervention (T1)

  • +5 more secondary outcomes

Study Arms (2)

Co-designed tailored physical activity program

EXPERIMENTAL
Other: Co-designed tailored physical activity program

Classical tailored physical activity program

ACTIVE COMPARATOR
Other: Classical tailored physical activity program

Interventions

The 'Classical tailored physical activity program'(control) group follows a classic adapted physical activity program not co-created, of the same duration of 12 weeks with 2 sessions per week.

Classical tailored physical activity program

The 'Co-designed tailored physical activity program' group follows a co-created adapted physical activity program, consisting of two sessions per week for 12 weeks, including adapted physical and sporting activities (APSA) chosen by the participants themselves (3 out of 5 offered). Within the experimental group, participants are grouped according to their level of physical ability. In addition, a group discussion with the Adapted Physical Activity Instructor is scheduled every four weeks.

Co-designed tailored physical activity program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 60 years of age or older
  • Be characterized by stage 1, 2, or 3 according to the Transtheoretical Model of Behavior Change (Prochaska and DiClemente, 1992).
  • Be registered with social security
  • Sign the informed consent form

You may not qualify if:

  • Presence of a physical or cognitive condition preventing completion of the adapted physical activity protocol over 3 months.
  • Being characterized by stage 4 or 5 according to the Transtheoretical Model of Behavior Change (Prochaska and DiClemente, 1992).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France

Location

Study Officials

  • Olivier GUERIN, Pr

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier GUERIN, Pr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2026

First Posted

May 12, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

May 5, 2028

Study Completion (Estimated)

May 5, 2028

Last Updated

May 12, 2026

Record last verified: 2026-04

Locations