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Clinical Trials/NCT05033184
NCT05033184CompletedNot Applicable

Effectiveness of a Brief Internet-delivered Behaviour Change Intervention Among Healthy Middle-aged Adults: A Randomized Controlled Trial

University of Regina1 site in 1 country178 target enrollmentStarted: October 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
178
Locations
1
Primary Endpoint
International Physical Activity Questionnaire (Baseline)

Study Overview

Brief Summary

Previous studies have demonstrated the need to move beyond the common misconception of midlife as a time of crisis so that further understandings of the midlife as a time of opportunity for the maintenance and improvement of health can be developed. Several psychosocial factors such as resilience, emotion regulation, perceived social support, and control beliefs have been identified as having a role in the adoption of healthier lifestyle habits in middle age which, in turn, may decrease the risk of a developing or worsening chronic disease. Several behaviour change interventions have also been proposed in the literature. As Canada's population ages, it is important that brief behaviour change interventions, and the psychosocial factors that facilitate such behaviour changes, be identified as a way to promote better health during the midlife years so as to improve the experience of aging. The present study is aimed at evaluating the influence of psychosocial factors on the adoption of healthy lifestyle habits. Specifically, this study aims to examine whether differing experiences of social support, resilience, emotion regulation, and control beliefs influence physical activity levels following a brief behaviour change intervention. Participants will be asked to complete a demographics questionnaire followed by a series of measures to determine the individual's perceived levels of social support, resilience, emotion regulation, and control beliefs. After completing this set of questionnaires, participants will be randomly assigned to either an experimental or a control condition. Participants in the experimental condition will be asked to complete the Brief Action Planning exercise as a way to identify a goal related to health behaviours. Participants in the control condition will be asked to identify a goal related to health behaviours without being introduced to the Brief Action Planning exercise. Two weeks and four weeks following this intervention, individuals will be asked to indicate the degree to which they were able to achieve their health goal. It is expected that individuals in the experimental condition will experience greater improvement in physical activity levels compared to individuals in the control condition. The investigators also anticipate that improvements in physical activity levels in the experimental condition will be influenced by the psychosocial factors of social support, resilience, emotion regulation, and control beliefs. The potential significance of this study includes increasing awareness of the influence of psychosocial factors on health behaviours and the possible effectiveness of a brief behaviour change intervention among middle-aged adults. Potential interventions may be used in clinical settings or community programs in which middle-aged adults engage.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
35 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Residing in Saskatchewan, Canada
  • •Between the ages of 35 and 64 years
  • •Deemed eligible to increase physical activity levels by the Physical Activity Readiness Questionnaire for Everyone (Par-Q+; Canadian Society for Exercise Physiology, 2019)

Exclusion Criteria

  • •Residing outside of Saskatchewan, Canada
  • •Under the age of 35 years or over the age of 64 years
  • •Deemed ineligible to increase physical activity levels by the Physical Activity Readiness Questionnaire for Everyone (Par-Q+; Canadian Society for Exercise Physiology, 2019)

Arms & Interventions

Brief Action Planning Exercise

Experimental

Intervention: Brief Action Planning Exercise (Behavioral)

Goal Setting Exercise

Active Comparator

Intervention: Goal Setting Exercise (Behavioral)

Outcomes

Primary Outcomes

International Physical Activity Questionnaire (Baseline)

Time Frame: Baseline Period

Our final outcome measure will be the International Physical Activity Questionnaire (IPAQ). The IPAQ will measure the degree to which participants spent time on vigorous, moderate, walking, and sitting activities. The IPAQ gets scored as categories (low activity levels, moderate activity levels, and high activity levels). A score of high activity levels is assigned to those who engage in vigorous activities at least 3 days a week OR 7 or more days of any combination of walking, moderate intensity, or vigorous activities. A score of moderate levels of physical activity will be assigned to those who engage in 3 or more days of vigorous activity and/ or walking of at least 30 minutes per day OR 5 or more days of moderate intensity activity and/or walking at least 30 minutes per day OR 5 or more days of any combination of walking, moderate intensity or vigorous activities. Those who do not meet the criteria for either vigorous or moderate will be scored as having low levels of activity.

International Physical Activity Questionnaire (Follow-Up 1)

Time Frame: 2-Week Follow-Up Period

Our final outcome measure will be the International Physical Activity Questionnaire (IPAQ). The IPAQ will measure the degree to which participants spent time on vigorous, moderate, walking, and sitting activities. The IPAQ gets scored as categories (low activity levels, moderate activity levels, and high activity levels). A score of high activity levels is assigned to those who engage in vigorous activities at least 3 days a week OR 7 or more days of any combination of walking, moderate intensity, or vigorous activities. A score of moderate levels of physical activity will be assigned to those who engage in 3 or more days of vigorous activity and/ or walking of at least 30 minutes per day OR 5 or more days of moderate intensity activity and/or walking at least 30 minutes per day OR 5 or more days of any combination of walking, moderate intensity or vigorous activities. Those who do not meet the criteria for either vigorous or moderate will be scored as having low levels of activity.

International Physical Activity Questionnaire (Follow-Up 2)

Time Frame: 4-Week Follow-Up Period

Our final outcome measure will be the International Physical Activity Questionnaire (IPAQ). The IPAQ will measure the degree to which participants spent time on vigorous, moderate, walking, and sitting activities. The IPAQ gets scored as categories (low activity levels, moderate activity levels, and high activity levels). A score of high activity levels is assigned to those who engage in vigorous activities at least 3 days a week OR 7 or more days of any combination of walking, moderate intensity, or vigorous activities. A score of moderate levels of physical activity will be assigned to those who engage in 3 or more days of vigorous activity and/ or walking of at least 30 minutes per day OR 5 or more days of moderate intensity activity and/or walking at least 30 minutes per day OR 5 or more days of any combination of walking, moderate intensity or vigorous activities. Those who do not meet the criteria for either vigorous or moderate will be scored as having low levels of activity.

Secondary Outcomes

  • Confidence (Follow-Up)(2-Week Follow-Up Period)
  • Achievement (Follow-Up 1)(2-Week Fellow-Up Period)
  • Achievement (Follow-Up 2)(4-Week Follow-Up Period)
  • Confidence (Baseline)(Baseline Period)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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