Trial record 4 of 21 for:    (gender OR sexual) AND identity

GrOup-based Physical Activity for oLder Adults Trial (GOAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02023632
First received: December 17, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

Regular physical activity is associated with a diverse range of physical and mental health outcomes, with the effects being particularly pronounced among older adults. Despite these health benefits, involvement in physical activity has been found to decline over the course of adulthood with older adults in particular risk of inactivity. A growing body of evidence, however, suggests that group-based settings that are sensitive to both the age-composition and gender-composition of their constituent members may represent an opportune means of supporting the improved adoption and maintenance of older adults in physical activity programs. The overall purpose of this feasibility trial is to test the effectiveness of a group-based physical activity program for older adults that is sensitive to both age-congruent and gender-congruent contextual factors, in supporting their sustained involvement in physical activity.


Condition Intervention
Motor Activity
Behavioral: Similar-Age-Same-Gender (SASG)
Behavioral: Similar-Age-Mixed-Gender (SAMG)
Behavioral: Mixed-Age-Mixed-Gender (MASG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Self-categorization Theory Approach to Fostering Physical Activity Adherence Among Older Adults: A Randomized Controlled Feasibility Trial.

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Program adherence and re-enrollment [ Time Frame: Month 3 (June 2014;2015) and Month 6 (August 2014;2015) ] [ Designated as safety issue: No ]
    Physical activity centre records (i.e., the YMCA) will be utilized to provide an objective measure of class attendance through "signing-in". With regard to the secondary research question concerning the extent to which participants choose to re-enroll after the initial 3-month program has ended, program enrollment records will again be used.


Secondary Outcome Measures:
  • Change in Cohesion [ Time Frame: Weeks 2, 7, 12, 14, 19, 24 ] [ Designated as safety issue: No ]
    Class cohesion will be assessed using the Physical Activity Group Environment Questionnaire (PAGEQ. The PAGEQ is a 21-item self-report questionnaire designed to assess four dimensions of cohesion within exercise classes; namely, attraction to the group's task (ATG-T), and social (ATG-S) activities, as well as perceptions of group integration around the group's task (GI-T), and social (GI-S) activities. The PAGEQ was developed (by Dr. Estabrooks, Co-I) specifically with older adults in mind taking part in physical activity classes such as those involved in this trial, with scores derived from this instrument demonstrating good reliability (α ≥ .72), factorial validity, and predictive utility.

  • Change in Affective and Instrumental Attitudes [ Time Frame: Weeks 2, 7, 12, 14, 19, 24 ] [ Designated as safety issue: No ]
    Affective attitudes towards physical activity will be assessed using the procedures outlined by Ajzen (2002). Specifically, a 7-point semantic differential scale will be used, with anchors including "Enjoyable—Unenjoyable", "Pleasant—Unpleasant", "Interesting—Boring". Previous research with older adults has found support for both the internal consistency and predictive utility of scores derived from this instrument.

  • Physical Health Screening Measure [ Time Frame: Month 1 (February 2014 and February 2015) ] [ Designated as safety issue: Yes ]
    For pre-screening all individuals will complete the Physical Activity Readiness Questionnaire for everyone (PAR-Q+). If participants respond 'NO' to all of the (seven) questions within the PAR-Q+ they are cleared for participation in physical activity. If participants have a positive response to the PAR-Q+ (e.g., due to a current medical condition), participants automatically proceed to a second series of questions subsumed within the ePARmed-X. As a result of completing the ePARmed-X, they will either be cleared for participation in physical activity OR will be directed to their physician to obtain clearance before they can participate in physical activity. If older adults have a medical contraindication (flagged through the PAR-Q+ and ePARmedX) and have NOT been cleared to participate in physical activity by their physician they are then ineligible to participate in the study.

  • Change in Self-efficacy [ Time Frame: Weeks 2, 7, 12, 14, 19, 24 ] [ Designated as safety issue: No ]
    During the program, in-class task self-efficacy will be measured through a validated and reliable measure (Poag-Ducharme & Brawley, 1993). Self-efficacy to overcome barriers to exercise (with an emphasis on self-regulation) will use Bray and colleagues (2001) validated and reliable measure; using 0-100% confidence. An example self-efficacy question is: how confident they may be in "Completing the warm-up and stretching component of each class."

  • Change in Stigma Consciousness [ Time Frame: Weeks 2, 7, 12, 14, 19, 24 ] [ Designated as safety issue: No ]
    To measure both gender and ethnicity stigma, we will use Pinel's (1999) measure for "stigma consciousness." Each item is on a 6-point Likert scale. An example item is "I never worry that I will be viewed as being stereotypically [fe]male."

  • Change in Flourishing [ Time Frame: Weeks 2, 7, 12, 14, 19, 24 ] [ Designated as safety issue: No ]
    Diener et al's(2009) well-being measure of the relationship of flourishing and positive and negative feelings will be distributed post-class at each of the times listed above. This measure is on a 7-point Likert scale from strongly disagree to strongly agree with items such as "I am engaged and interested in my daily activities" and "I am a good person and live a good life."

  • Change in Perceptual Similarity [ Time Frame: Weeks 2, 14 ] [ Designated as safety issue: No ]
    Using methods from Beauchamp et al (2012), participants will answer a series of questions regarding their perceived similarity via a 9-point Likert scale. Surface-level perceptions will be assessed through items related to age, physical condition, and physical appearance similarity, whereas deep-level perceptions will be assessed through items related to attitude, belief, and value similarity. Exemplar items from this assessment included, "In my exercise class, I believe members are similar to me in terms of age."

  • Change in commute time and commute mode [ Time Frame: Weeks 2 and 14 ] [ Designated as safety issue: No ]
    Two-item assessment of how participants commute to the YMCA location: 1. Typically, how long does it take for you to get to your physical activity class (i.e., commute time):________________ mins and 2) What mode of transport do you use to get to your physical activity class (car, bus, bike, train, walk, taxi):_____________________.

  • Change in Group-Interaction Variables [ Time Frame: Weeks 7 and 19 ] [ Designated as safety issue: No ]
    To measure the group-interaction variables of interest (i.e., communication, cooperation, and competition) additional items are embedded within the PAGEQ. Communication will be measured through 6 items that can be further divided into task communication (e.g., 'members of our group talk about how often they should do physical activity') and social communication (e.g., 'people of this group talk about things that are happening in our lives'). Cooperation will be measured through 3 items (e.g., 'we all cooperate to help this group's program run smoothly') as will competition (e.g., 'There is friendly competition within the members to stay as healthy as possible'). Internal consistencies for the group-interaction variables were all previously acceptable: task communication (α = .94), social communication (α = .65), cooperation (α = .91), and friendly competition (α = .81) (Harden, Mama, Lee, Estabrooks, Under Review).

  • Change in Physical Activity Outside of the YMCA [ Time Frame: Week 12, 24 ] [ Designated as safety issue: No ]
    Physical activity outside of program will be measured by an adapted 3-step procedure outlined by Wilcox et al. (1999), specific for older adults. Participants will report on various activities that they engaged in over the last two weeks as well as how many times and the duration associated with each. Participants will also answer whether they experienced (a) no, (b) small, (c) moderate, or (d) large increases in heart and breathing rates while participating.

  • Change in Functional Fitness Appraisal [ Time Frame: Month 1 (Feb) and Month 6 (August) ] [ Designated as safety issue: No ]
    Functional fitness testing will be conducted based on a previously developed and validated functional fitness test for community-residing older adults (Rikli, R. E., & Jones, C. J. 1999). The assessment will include measures of upper and lower body strength and flexibility, aerobic endurance, dynamic balance, and Body Mass Index. These tests will be done at the participant's local YMCA by trained research assistants.


Other Outcome Measures:
  • Process Evaluation [ Time Frame: After month 6 for each cohort ] [ Designated as safety issue: No ]
    The process evaluation procedures to be used in this study first involves identifying fidelity to the five key components of the intervention. Second, semi-structured interviews will be used that allow us to examine each of the subcomponents described in the first step. Interviews will be conducted with participants by trained research assistants, and although qualitative data analysis will be overseen by the principal investigator, the coding will be performed by research assistants (i.e., unconnected with the intervention activities).


Estimated Enrollment: 540
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Similar-Age-Same-Gender (SASG)
Participants in this trial arm will be of similar age (65+) and of the same gender (i.e., separate groups for male older adults and female older adults).
Behavioral: Similar-Age-Same-Gender (SASG)
The core feature of the program is that it is exclusively for those of a similar age and same gender. Such an environment was reported to provide opportunities for social connectedness, as well as personal comfort. Secondly, exercise class instructors are volunteers- both providing 'similar-models' to enhance efficacy as well as reduce costs associated with instructors. Consistent with social identity and self-categorization perspectives, the program also makes use of a series of strategies to foster intra-group attraction and group identity. For many of the participants a major draw of the program is that it provides opportunities for the older adults to connect with one another after the classes have ended.
Active Comparator: Similar-Age-Mixed-Gender (SAMG)
This group will include participants of both genders who are similar aged (65+).
Behavioral: Similar-Age-Mixed-Gender (SAMG)
The SAMG physical activity condition will mirror the SASG group condition, but will be open to older adults from both genders. The same strategies to those used within the SASG condition will also be utilized (development of a unique program name, T-shirts, opportunities to socialize after the program), and will be offered three days per week (Mon, Wed, Fri, or Tues, Thurs, Sat). Older adults will also be recruited to be instructors for the group classes (= 65 years), with both males and females invited to occupy these instructional roles. (As with the SASG condition, training will take place between September and December 2013, through the respective YMCA centres. The YMCA will oversee the training of these volunteers through their Fitness Leader Training Program).
Sham Comparator: Mixed-Age-Mixed-Gender (MASG)
This group is used as the 'standard' group based exercise course; including those of mixed age and mixed gender.
Behavioral: Mixed-Age-Mixed-Gender (MASG)
The third condition utilized within the RCT is designed to reflect 'standard' group based exercises that one sees in typical physical activity centres. Specifically, these classes are not restricted to participants on the basis of age or gender, and as such older adults will be participating in groups comprised of people younger than themselves as well as those of both gender.

Detailed Description:

The results of prominent meta-analytic reviews suggest that when people exercise in groups they tend to sustain their involvement to a greater extent than when they exercise on their own. Despite the potential for groups to sustain long-term physical activity behaviours, there appears to be an important caveat that comes with exercising with others: if people perceive themselves to be similar to other members of a given group, in terms of salient underlying qualities, this corresponds positively with their attraction to, and level of involvement within, that group. If, however, people perceive themselves to be distinctly different from others within their social group, this is likely to undermine their attraction to, and involvement in that group. Recent research by Dr. Beauchamp and his team suggests that across the adult age spectrum people report a positive preference for exercising within groups that are comprised of others their own age, and when they participate in such classes they display higher levels of adherence to the group. In a similar regard, people report comparable positive preferences for same-gender rather than mixed-gender physical activity group settings. However, to date, research has yet to examine these effects using an experimental (RCT) design. This constitutes the purpose of this present trial.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must be 65 years of age or older (both males and females), be able to speak and read English, and not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity. Participants will be required to complete PAR-Q+, and where necessary ePARmed-X.

Exclusion Criteria:

  • The only exclusionary criteria is that participants must be 65 years of age or older (both males and females), be able to speak and read English, and not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023632

Contacts
Contact: Samantha M Harden, PhD 7788833193 samantha.harden@ubc.ca
Contact: Mark R Beauchamp, PhD (604) 822 - 4864 mark.beauchamp@ubc.ca

Locations
Canada, British Columbia
Langara YMCA Recruiting
Richmond, British Columbia, Canada, V5Y 2Z5
Contact: Samantha M Harden, PhD         
Sub-Investigator: Samantha M Harden, PhD         
Surrey Family YMCA Recruiting
Surrey, British Columbia, Canada, V3S 7S6
Contact: Samantha Harden, PhD       goaltrial@gmail.com   
Sub-Investigator: Samantha M Harden, PhD         
Robert Lee YMCA Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y2
Contact: Samantha M Harden, PhD         
Sub-Investigator: Samantha M Harden, PhD         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Mark R Beauchamp, PhD University of British Columbia
  More Information

Publications:
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02023632     History of Changes
Other Study ID Numbers: H13-01593, DCO150GP
Study First Received: December 17, 2013
Last Updated: July 2, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
older adults
physical activity
self-categorization
group dynamics
self-identity

ClinicalTrials.gov processed this record on August 19, 2014