NCT07113860

Brief Summary

The goal of this clinical trial is to promote positive views on aging and walking in Spanish partners aged 65 years and over. The trial will comprise three arms. In the first arm, both partners will undertake the intervention together. In the second arm, only one of the two partners will undertake the intervention. In the third arm (control) none of the partners will undertake the intervention. Collection of quantitative data will make it possible to test the following hypotheses:

  • Three in-person psychoeducational sessions aiming to promote positive views on aging, including positive self-perceptions of aging, and accurate facts about aging
  • Independent walking for 12 weeks Primary intervention outcomes are changes in participants' self-perceptions of aging and physical activity engagement. Secondary intervention outcomes are changes in ageism, subjective views of couple's joint aging, perceived age-related changes in one's partner, mood, physical fitness, and cognitive functioning.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress36%
Jul 2025Oct 2027

First Submitted

Initial submission to the registry

July 3, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

July 28, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

July 3, 2025

Last Update Submit

August 14, 2025

Conditions

Keywords

Physical activityWalkingSelf-Perceptions of AgingAgeismSubjective agingcouplesspouses

Outcome Measures

Primary Outcomes (5)

  • Awareness of Age-Related Change

    This 10-item measure assesses self-perceptions of aging. More specifically, it assesses perceived age-related gains and losses. Each of the items of the perceived age-related gains and losses subscales represents one of the five AARC behavioral domains that are health and physical functioning; cognitive functioning; interpersonal relations; social-cognitive and social-emotional functioning; and lifestyle and engagement. Respondents rate how much each item applies to them on a five-point Likert scale (1= not at all; 2= a little bit; 3= moderately; 4= quite a bit; 5= very much). Higher scores indicate higher perceived age-related gains and losses, respectively (range: 5-25).

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

  • Felt Age

    This measure assesses self-perceptions of aging. Felt age (FA) will be assessed with a single-item question asking participants to write the age (in years) that they feel most of the time. A proportional discrepancy score will be calculated by subtracting the participants' chronological age from their felt age, and by dividing this difference score by participants' chronological age. A positive value indicates an older felt age, whereas a negative value indicates a younger felt age. Typically, in western countries the majority of older individuals feel between 13% and 18% younger than their age, and a younger felt age is used as indicator of more positive self-perceptions of aging.

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

  • Subjective Nearness to Death

    This measure assesses self-perceptions of aging. Subjective Nearness to Death will be assessed with the one-item question: I have a feeling that my life is approaching its end. Answer options range from 1 (not at all) to 5 (very much).

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

  • International Physical Activity Questionnaire

    This measure assesses self-reported physical activity. Participants are asked to refer to the past seven days and to report how much time they spent sitting during a day; how many days they walked for at least ten minutes at a time; how many days they did moderate physical activities like gardening, cleaning, and bicycling; and how many days they did vigorous physical activities like heavy lifting, heavier garden or construction work, and aerobics. Separate scores can be obtained for walking, moderate intensity physical activities, and vigorous physical activities as follows: (1) Walking metabolic equivalent of task (MET)-minutes/week = 3.3 \* walking minutes \* walking days. (2) Moderate MET-minutes/week = 4.0 \* moderate-intensity activity minutes \* moderate days. (3) Vigorous MET-minutes/week = 8.0 \* vigorous-intensity activity minutes \* vigorous-intensity days. The International Physical Activity Questionnaire total score derives from the sum of the scores for walking, moderate-inten

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

  • Saltin-Grimby Physical Activity Level Scale

    This measure assesses self-reported physical activity.The Saltin-Grimby Physical Activity Level Scale consists in a single-item question asking participants to report on average how much they moved during their leisure time. At baseline participants will be asked to answer thinking about the past 12 months whereas at follow-ups they will be asked to think about the past three months. To answer, participants can choose from four categories: 1= physically inactive, 2= some light physical activity, 3= regular physical activity and training, and 4= regular hard physical training for competitive sports.

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

Secondary Outcomes (12)

  • World Health Organization - Ageism Scale

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

  • Subjective Views of Couple's Joint Aging

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

  • Patient Health Questionnaire - 4

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

  • Body Mass Index

    Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)

  • Grip Strength

    Baseline, post-intervention (12 weeks after baseline), and six-months follow-ups (post-intervention)

  • +7 more secondary outcomes

Study Arms (3)

Intervention delivered to both partners/spouses

EXPERIMENTAL

Both partners/spouses will undertake together a multi-component intervention comprising a psychoeducational component (aiming to promote positive views on aging via three in-person sessions) and a behavioral component (asking participants to start walking up to five times per week for 12 weeks).

Behavioral: Views on Aging InterventionBehavioral: Projecte Moviment

One partner/spouse undertakes the intervention

ACTIVE COMPARATOR

Only one of the two partners/spouses will undertake the multi-component intervention during data collection. The remaining partner will be offered the opportunity to undertake the intervention at the end of data collection. The intervention is the same delivered to arm one and it comprises a psychoeducational component (aiming to promote positive views on aging via three in-person sessions) and a behavioral component (aiming to promote walking up to five times per week for 12 weeks).

Behavioral: Views on Aging InterventionBehavioral: Projecte Moviment

Partners/spouses do not undertake the intervention

NO INTERVENTION

This is the control group/arm. None of the spouses/partners undertakes the intervention during data collection. They will be offered the opportunity to undertake the intervention at the end of data collection.

Interventions

This intervention was developed by Wolff, Warner (47) in 2013-2014; refined by Beyer, Wolff (59) in 2017-2018; and further refined for this project. It will be delivered through three in-person one-hour sessions by two psychologists. it will include homework between sessions two and three. The first session will consist of a quiz on aging with questions about healthy aging and aging in general to detect own negative personal views on aging and misconceptions regarding aging. The second session will provide information on the benefits of more positive views on aging on health, functional and cognitive abilities, and longevity. During the third session participants are thought a technique to modify negative automatic thoughts about aging and asked/invited to put in practice this technique. Finally, the intervention ends with a focus on positive views on aging and their importance for one's health and wellbeing.

Intervention delivered to both partners/spousesOne partner/spouse undertakes the intervention

The intervention lasts 12 weeks and is based on international guidelines of physical exercise. Participants will be instructed to walk briskly in one continuous bout (45 minutes for 5 days, 225 minutes per week). Intensity, duration, and times per week will be initiated in a stepwise manner to reduce the possibility of injury. During the first week participants will be asked to walk 30 minutes at 9-10 on the Borg Rating of Perceived Exertion Scale (i.e., light intensity). During the second week, participants will be asked to walk 45 minutes with the same intensity. During the remaining weeks, participants will be asked to maintain the duration of 45 minutes and increase the intensity of the activity to a moderate-high effort that corresponds with 12-14 in the Borg Rating of Perceived Exertion Scale.

Intervention delivered to both partners/spousesOne partner/spouse undertakes the intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • living in the community in Barcelona or nearby areas;
  • both partners being aged ≥ 65 years;
  • speaking fluent Catalan or Spanish;
  • being married, having a partner with whom they co-habit, or having had a partner for at least one year and with whom they meet at least twice a week;
  • having access to a smartphone, tablet, laptop, or computer with internet;
  • both partners being willing to participate in the study and providing written informed consent.

You may not qualify if:

  • having a self-reported or clinically diagnosed neurodegenerative disorder, and/or an Adult Lifestyles and Function Interview Mini Mental State Examination (ALFI-MMSE) score of \< 15 out of 22, indicating mild cognitive impairment or dementia. The research team has considerable experience with the administration of the MMSE and will adjust scores for individuals with low cultural background;
  • currently having a clinical diagnosis of mental health disorder that significantly impacts on the daily functioning of the individual (i.e., a diagnosis that significantly impacts the participants ability to work, do house chores, and/or engage socially);
  • current substance use disorder (alcohol or drug abuse), or a history of substance abuse within the past five years that may interfere with study participation or adherence to the intervention;
  • having a physical condition or physical limitations that impair from starting a physical activity intervention consisting in walking between three to five times per week and to do some physical tasks such as stand up from and sit down on a chair and back scratch;
  • severe hearing impairment (deafness).
  • Physical limitations will be self-reported by participants via phone but also further objectively assessed by the researchers at baseline assessment. Individuals with neurodegenerative disorders will be excluded as it could be difficult for them to understand and participate in the psychoeducational sessions, and/or engage in brisk walking. Individuals with current severe mental health disorders and/or with substance abuse will be excluded as these groups are less likely to be compliant with intervention conditions. However, individuals with more common mental health disorders (i.e., depressive disorders and anxiety disorders) that are not severe enough to significantly impact the daily functioning of the individual will be allowed to take part in the study. Individuals with significant physical limitations will be excluded as they could put themselves at risk of falling while engaging in physical activity/walking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychobiology at the University of Barcelona.

Barcelona, Catalonia, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Motor ActivityAgeism

Condition Hierarchy (Ancestors)

BehaviorPrejudiceSocial BehaviorSocial Discrimination

Study Officials

  • Serena Sabatini, PhD in Psychology

    University of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serena Sabatini, PhD in Psychology

CONTACT

Maria Mataro Serrat, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person who will interact with participants to send out questionnaires, plan assessment dates, etc will be blinded. The person who assesses participants will also be blinded.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: In the first group/arm, both partners/spouses will undertake the intervention together. In the second group/arm, only one of the two partners will undertake the intervention during data collection. In the third (control) group/arm none of the partners will undertake the intervention during data collection.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Psychology

Study Record Dates

First Submitted

July 3, 2025

First Posted

August 11, 2025

Study Start

July 28, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Anonymised data will be shared in Open Science Framework once study analyses will have been conducted and the planned publications will have been published.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The study protocol will be available from the start of the project (a detailed protocol will be made available in Open Science Framework). The IPD will be made available at the end of data analyses. We expect tho share IPD by 2028. The analysis plan will be made available at the end of data collection (2027) and the analytic code once data analyses will have been completed (by 2028).
Access Criteria
Everyone will be able to access the anonymised IPD and supporting information via Open Science Framework from 2028.
More information

Locations