Reframing Expectations About Aging - Physical Activity and Inclusive Reappraisal (RE-PAIR): Protocol of an Intervention Aiming to Promote Positive Views on Aging and Behavior Change in Older Couples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Awareness of Age-Related Change
研究概览
简要总结
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:
- Differently from arm three, those participants from arms one and two who undertake the intervention will experience changes in primary and secondary intervention outcomes between pre- and post-intervention and these changes will be maintained at follow-ups.
- Compared to delivering the intervention to only one partner, delivering it to both partners will lead to a greater and more lasting change in primary and secondary intervention outcomes.
- In the group where only one partner will undertake the intervention, their change in intervention outcomes is observed at least to a small extent in the other partner.
Qualitative data collected at the end of the intervention through interviews of ten couples from each of arms one and two will make it possible to test three additional research questions:
- How do participants in Group one engage with the intervention tasks, and to what extent do they undertake these tasks jointly as a couple?
- In what ways do participants in Group two involve their non-participating partner in the intervention activities?
- What changes do participants in Groups one and two report in their views of themselves and their aging, as well as in their perceptions of and interactions with their partner?
Participants will undertake a multicomponent intervention comprising:
- 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.
详细描述
The current study will adopt a randomized pre- and post- intervention/trial design. A multicomponent (psychoeducational and behavioral) intervention called RE-PAIR (Reframing Expectations about aging - Physical Activity and Inclusive Reappraisal) and aiming to promote positive self-perceptions of aging and walking in older couples (i.e., spouses, cohabiting partners, or long-standing non-cohabiting partners) will be delivered to three intervention 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 (control) arm none of the partners will undertake the intervention.
Quantitative data collected through this trial design will make it possible to test four main hypotheses. First, based on previous research that tested the efficacy of the same psychoeducational intervention that will be used in this trial, it is hypothesized that, differently from the control group, those participants who undertake the intervention will experience changes in primary and secondary intervention outcomes between pre- and post-intervention and these changes will be maintained at follow-ups. Primary intervention outcomes are changes in 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. Second, based on previous evidence on physical activity, it is hypothesized that compared to when delivering the intervention to only one partner, delivering it to both partners will lead to a greater and more lasting change in primary and secondary intervention outcomes. Third, it is hypothesized that in the group/arm where only one partner will undertake the intervention, their change in intervention outcomes is observed at least to a small extent in the other partner due to partners tending to influence each other's beliefs and behaviors. Finally, qualitative data collected at the end of the intervention through interviews of ten couples from each of groups 1 and 2 will make it possible to test three additional research questions. First, how do participants in arm 1 engage with the intervention tasks, and to what extent do they undertake these tasks jointly as a couple? Second, in what ways do participants in arm 2 involve their non-participating partner in the intervention activities? Third, what changes do participants in arms 1 and 2 report in their views of themselves and their aging, as well as in their perceptions of and interactions with their partner?
After having obtained participants' written informed consent in person, baseline, immediately post-intervention, and six-month follow-up assessments will be conducted as one-on-one sessions in the facilities of the Department of Clinical Psychology and Psychobiology of the University of Barcelona or in collaborating centers. During these assessments, participants will also independently complete some online questionnaires. The three-month follow-up assessment will instead be conducted online only. The sessions of the psychoeducational intervention will be conducted as group sessions in a small seminar room of the Department of Clinical Psychology and Psychobiology at the University of Barcelona or in collaborating centers. The behavioral component of the intervention will be undertaken independently by participants after having received instructions by the researchers.
This study aims to recruit 342 participants (i.e., 171 couples), randomly allocating 114 (i.e., 57 couples) to each of the three intervention arms. It is estimated that 342 participants are needed to provide 90% power at the two-sided 5% level of significance to detect a mean change of three units (i.e., moderate effects) on personal views on aging between any of the three study groups. As some participants may withdraw from the trial, the sample size calculation accounts for 30% drop out of participants.
It is expected that recruitment will last at least 12 months (between July 2025 and July 2026). Participants will be recruited via flyers, newsletters, and presentations at local organizations such as Amics de la Gent Gran; Fundació Catalunya La Pedrera; Universitat de l'experiència within the University of Barcelona; Federacio d'associacions de gent gran de Catalunya; IDIAP Jordi Gol Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina. Primary care centers will also be contacted to recruit participants. Presentations will be delivered by the principal investigator (Dr Serena Sabatini) and a PhD candidate in Psychology. Participants will also be recruited through social media such as X, Facebook, Instagram, and LinkedIn. Snowballing technique will also be used. Should recruitment be slow, sources of recruitment will be diversified through contact of associations outside Barcelona.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Although the use of a chronological age cut-off to define older people is inherently arbitrary, this study adopts the threshold of 65 years and older to establish inclusion criteria for participation. This decision reflects the increasing self-relevance of age-stereotypes and self-perceptions of aging in later life, particularly among the oldest age groups. Participants can either possess a device that can be connected to the internet or use the device of a family member, neighbor, or friend. Moreover, participants with low technology literacy can nonetheless take part in the study as during baseline assessment the research team will show them how to complete the online questionnaires. Moreover, the research team will be available via email and phone to answer participants' queries related to completion of the online questionnaires. Both retired and working people are eligible to take part in the study. People of any race can take part in the study. Couples of all sexual orientations are welcome to participate in the study.
排除标准
- •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.
研究组 & 干预措施
Intervention delivered to both partners/spouses
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).
干预措施: Views on Aging Intervention (Behavioral)
Intervention delivered to both partners/spouses
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).
干预措施: Projecte Moviment (Behavioral)
One partner/spouse undertakes the intervention
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).
干预措施: Views on Aging Intervention (Behavioral)
One partner/spouse undertakes the intervention
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).
干预措施: Projecte Moviment (Behavioral)
Partners/spouses do not undertake the 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.
结局指标
主要结局
Awareness of Age-Related Change
时间窗: Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)
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).
Felt Age
时间窗: Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)
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.
Subjective Nearness to Death
时间窗: Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)
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).
International Physical Activity Questionnaire
时间窗: Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)
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
Saltin-Grimby Physical Activity Level Scale
时间窗: Baseline, post-intervention (12 weeks after baseline), and three- and six-months follow-ups (post-intervention)
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.
次要结局
- 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))
- Senior Fitness Test(Baseline, post-intervention (12 weeks after baseline), and six-months follow-ups (post-intervention))
- Trial Making Text A and B(Baseline, post-intervention (12 weeks after baseline), and six-months follow-ups (post-intervention))
- Digit Span Forward and Backward(Baseline, post-intervention (12 weeks after baseline), and six-months follow-ups (post-intervention))
- PMR Phonological Verbal Fluency Test(Baseline, post-intervention (12 weeks after baseline), and six-months follow-ups (post-intervention))
- Animal Naming Fluency Test(Baseline, post-intervention (12 weeks after baseline), and six-months follow-ups (post-intervention))
- Weist circumference(Baseline, three-months follow-up, and 6-months follow-up.)
- Stroop Color-Word Test(Baseline, three-month follow-up and six-month follow-up. In this test, participants are shown a list of color words, such as "red," "blue," "green", printed in different-colored inks. The ink color may match the word (i.e., congruent condition) or differ)
研究者
Serena Sabatini
PhD in Psychology
University of Barcelona