Health BehaviorNCT05033184
Effectiveness of a Brief Internet-delivered Behaviour Change Intervention Among Healthy Middle-aged Adults
A study testing Brief Action Planning Exercise and Goal Setting Exercise in people with Health Behavior, run by University of Regina at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Brief Action Planning Exercise and Goal Setting Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Brief Internet-delivered Behaviour Change Intervention Among Healthy Middle-aged Adults: A Randomized Controlled Trial
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.
- Conditions
- Health Behavior
- Being tested
- Brief Action Planning Exercise, Goal Setting Exercise
- Keywords
- Physical Activity, Control Beliefs, Emotion Regulation, Resilience, Social Support
- Medical subject headings
- Health Behavior, Motor Activity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Action Planning ExerciseBehavioural
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Action Planning Exercise | Experimental | Not described Receives: Behavioral: Brief Action Planning Exercise |
| Goal Setting Exercise | Active comparator | Not described Receives: Behavioral: Goal Setting Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (Baseline)
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.
Measured: Baseline Period
International Physical Activity Questionnaire (Follow-Up 1)
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.
Measured: 2-Week Follow-Up Period
International Physical Activity Questionnaire (Follow-Up 2)
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.
Measured: 4-Week Follow-Up Period
Secondary outcomes (4)
Confidence (Baseline)
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.
Measured: Baseline Period
Confidence (Follow-Up)
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.
Measured: 2-Week Follow-Up Period
Achievement (Follow-Up 1)
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.'
Measured: 2-Week Fellow-Up Period
Achievement (Follow-Up 2)
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.'
Measured: 4-Week Follow-Up Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Oct 2021
- Primary completion30 Apr 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natasha L Gallant, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033184
- Sponsor's protocol ID
- 2021-074
- Status last verified
- Nov 2022
- First submitted
- 24 Aug 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study's principal investigator, supervisor, and project investigators will be the only persons with access to the data.
Publications
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Warburton DER, Jamnik VK, Bredin SSD, Gledhill N on behalf of the PAR-Q+ Collaboration. The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and Electronic Physical Activity Readiness Medical Examination (ePARmed-X+). Health & Fitness Journal of Canada. 2011; 4(2): 3-23.
Infurna FJ, Gerstorf D, Lachman ME. Midlife in the 2020s: Opportunities and challenges. Am Psychol. 2020 May-Jun;75(4):470-485. doi: 10.1037/amp0000591.
PubMed 32378943Lachman ME, Teshale S, Agrigoroaei S. Midlife as a Pivotal Period in the Life Course: Balancing Growth and Decline at the Crossroads of Youth and Old Age. Int J Behav Dev. 2015 Jan 1;39(1):20-31. doi: 10.1177/0165025414533223.
PubMed 25580043Gutnick D, Reims K, Davis C, Gainforth H, Jay M, Cole S. Brief action planning to facilitate behavior change and support patient self-management. Journal of Clinical Outcomes Management. 2014; (21)1: 17-29.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief Internet-delivered Behaviour Change Intervention Among Healthy Middle-aged Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05033184
- Acronym / sponsor ID
- 2021-074
- Conditions
- Health Behavior
- Keywords
- Physical Activity, Control Beliefs, Emotion Regulation, Resilience, Social Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Action Planning Exercise | Experimental | Behavioral: Brief Action Planning Exercise |
| Goal Setting Exercise | Active comparator | Behavioral: Goal Setting Exercise |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Action Planning ExerciseThe 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. | Behavioural | Brief Action Planning Exercise |
| Goal Setting ExerciseThe 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. | Behavioural | Goal Setting Exercise |
Primary outcome
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.
4 secondary outcomes
Confidence (Baseline)
Time frame: Baseline Period
Confidence (Follow-Up)
Time frame: 2-Week Follow-Up Period
Achievement (Follow-Up 1)
Time frame: 2-Week Fellow-Up Period
Achievement (Follow-Up 2)
Time frame: 4-Week Follow-Up Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- BackgroundWarburton DER, Jamnik VK, Bredin SSD, Gledhill N on behalf of the PAR-Q+ Collaboration. The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and Electronic Physical Activity Readiness Medical Examination (ePARmed-X+). Health & Fitness Journal of Canada. 2011; 4(2): 3-23.
- Background: PubMed 32378943Infurna FJ, Gerstorf D, Lachman ME. Midlife in the 2020s: Opportunities and challenges. Am Psychol. 2020 May-Jun;75(4):470-485. doi: 10.1037/amp0000591.
- Background: PubMed 25580043Lachman ME, Teshale S, Agrigoroaei S. Midlife as a Pivotal Period in the Life Course: Balancing Growth and Decline at the Crossroads of Youth and Old Age. Int J Behav Dev. 2015 Jan 1;39(1):20-31. doi: 10.1177/0165025414533223.
- BackgroundGutnick D, Reims K, Davis C, Gainforth H, Jay M, Cole S. Brief action planning to facilitate behavior change and support patient self-management. Journal of Clinical Outcomes Management. 2014; (21)1: 17-29.
- Individual participant dataSharing planned: No. The study's principal investigator, supervisor, and project investigators will be the only persons with access to the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha L Gallant, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Action Planning Exercise and Goal Setting Exercise in people with Health Behavior, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (Baseline) (time frame: Baseline Period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05033184, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.