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Completed

NCT Number: NCT05033184

Effectiveness of a Brief Internet-delivered Behaviour Change Intervention Among Healthy Middle-aged Adults

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.

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Key information

Conditions

Health Behavior Behavior Emotional Regulation Motor Activity Self-Control Social Behavior

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Brief Action Planning Exercise

Behavioral

The Brief Action Planning exercise is a previously developed goal-setting exercise which has been designed to incorporate aspects of motivational interviewing such as compassion, acceptance, evocation, and partnership. It is a tool that allows participants to identify an aspect of their life they would like to improve upon and guides them through the process of making a specific, measurable, achievable, realistic, and timely (SMART) goal. It also assesses their confidence in achieving this goal so as to assist with making alternative plans if confidence is low.

Goal Setting Exercise

Behavioral

The Goal Setting exercise allows participants to identify an aspect of their life they would like to improve upon without incorporating aspects of motivational interviewing components or providing any guidance on how to set this goal.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Confidence (Baseline)

    Time frame: Baseline Period

    The Confidence outcome asks the participant to rate how confident they feel in following their plan The degree to which participants report that they are confident about carrying out their plan over the next two weeks on a scale from 1 to 10, with scores above 7 indicating high confidence and scores below 7 indicating low confidence.

  2. Confidence (Follow-Up)

    Time frame: 2-Week Follow-Up Period

    The Confidence outcome asks the participant to rate how confident they feel in following their plan The degree to which participants report that they are confident about carrying out their plan over the next two weeks on a scale from 1 to 10, with scores above 7 indicating high confidence and scores below 7 indicating low confidence.

  3. Achievement (Follow-Up 1)

    Time frame: 2-Week Fellow-Up Period

    The Achievement outcome asks the participant to rate the degree to which they followed their plan over the previous two weeks by selecting either 'fully,' 'partially,' or 'not at all.'

  4. Achievement (Follow-Up 2)

    Time frame: 4-Week Follow-Up Period

    The Achievement outcome asks the participant to rate the degree to which they followed their plan over the previous two weeks by selecting either 'fully,' 'partially,' or 'not at all.'

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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