Inactivity/Low Levels of ExerciseProActNCT06070038
A Collaborative Theory-based Intervention to Promote Physical Activity Among Sedentary Parents and Their Children
A study testing Integrated Behaviour Change Based Intervention Materials in people with Inactivity/Low Levels of Exercise and Inactivity, Physical, run by University of Jyvaskyla at 1 site in Finland.
Trial summary
Insufficient physical activity in children and adults is linked to increased risk of physical and mental health conditions. Parents have an important influence on their children's activity, and preliminary aimed at promoting physical activity suggest the family unit as a potentially efficacious means of delivery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inactivity/Low Levels of Exercise, Inactivity, Physical
- What is being tested?
- Integrated Behaviour Change Based Intervention Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteFinland
- Study dates
- 20 Sep 2023to Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent does not undertake at least 150 minutes of moderate-intensity (or 75 minutes of vigorous-intensity) physical activity each week.
- Child does not undertake at least 60 minutes of moderate-intensity or vigorous-intensity physical activity each day.
- Child is aged between 8 and 12 years old
Who cannot join
- Parent reports that either they or their child is currently meeting physical activity guidelines at screening.
- Parent states that they or their child has some physical condition that prohibits them from safely participating in physical activity.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
The Faculty of Sport and Health Sciences
Jyväskylä, Central Finland, 40014
Keegan Knittle, +358504698252, keegan.p.knittle@jyu.fi
About this study
Insufficient physical activity in children and adults is linked to increased risk of physical and mental health conditions. Parents have an important influence on their children's activity, and preliminary aimed at promoting physical activity suggest the family unit as a potentially efficacious means of delivery. However, there is relatively little research examining the efficacy of family interventions aimed at promoting both parents' and children's physical activity. In addition, many family-based interventions are not guided by behavioral theory known to enhance intervention efficacy and reduce variability, and do not target low-active families. This project will therefore develop and test the efficacy of a theory-based behavioral intervention to increase physical activity engagement in low-active children and their parents. The intervention will adopt a randomized waitlist-controlled design with parents and their children allocated to an intervention group that receives theory-based content targeting changes in key behavioral determinants or to a waitlist control group that receives measurement only. The intervention will be delivered to parent-child dyads in a series of four online meetings with a trained facilitator, accompanied by web-based supporting materials, and a moderated social support online chat group. The primary dependent variable will be parents' and children's leisure time physical activity, and secondary outcomes will be device measured physical activity (intervention group only) and measures of key theory-based determinants of physical activity, including autonomous motivation, attitudes, subjective norms, self-efficacy, intentions, and perceived autonomy support. These outcomes will be measured at baseline and at 3, 6, and 12 months post-baseline. Parents and children allocated to the intervention group are expected to exhibit higher levels of physical activity and behavioral determinants. Intervention effects on physical activity change are expected to be mediated by the theory-based determinants, consistent with psychological theory. The project will contribute to research by testing the efficacy of a unique intervention based on behavioral theory expected to be effective in promoting physical activity in low-active parents and their children, and providing guidelines and materials that practitioners in health promotion and public health can use in campaigns and national strategies to promote physical activity in this population.
Read the detailed description
Low levels of physical activity in adult and youth populations are associated with an increased risk of physical and mental health conditions and reduced quality of life. Conversely, regular activity participation is associated with reduced chronic disease risk and better psychological health and well-being. However, studies indicate that most young people and adults do not achieve recommended levels of physical activity. Physical activity participation also tends to decrease throughout childhood, with steep declines observed during adolescence. Consequently, effective means to promote physical activity participation in child and adult populations are needed. While family-based interventions represent a potentially useful environment for delivering behavioural interventions to promote physical activity in both parents and children, few interventions have been applied in this context. Those that have, tend not to have a strong basis in behavioural theory, often focus on short-term change, and are seldom evaluated systematically.
Within this project, we aim to develop an intervention to promote physical activity in low-active parents and their children. Based on previous research, an integrated model based on multiple theories from behavioural science, particularly social psychology, will guide the development of the intervention in the current project. Specifically, the model draws its predictions from two key behavioural theories: self-determination theory (SDT) and the theory of planned behaviour (TPB), two pre-eminent theoretical approaches that have been applied extensively to predict behaviour and guide interventions in health behaviour contexts.
Evidence suggests that a key approach to family-based behavioural interventions aimed at promoting physical activity in young people and their parents should focus on parent-child dyads, as they provide an efficient means to increase physical activity in both parties. Few studies have systematically evaluated the efficacy of behaviour change methods focused specifically on these kinds of dyad in changing physical activity in family-based interventions and further high-quality evidence is needed. Although the proposed integrated model has generally been used as a basis for interventions in individual contexts, it has not hitherto been adopted as a basis for family-based behaviour change interventions focused on dyads, yet is well placed to be adapted to inform such interventions. The model can also be modified to encompass dyad-focused versions of key determinants identified in the model. For example, the model can be modified to include dyad-based self-efficacy perceptions, a family-based revision of the self-efficacy construct in the model, which reflects perceived confidence in performing the target behaviour together with other dyad members and joint appraisal of goal progress.
- Being tested
- Integrated Behaviour Change Based Intervention Materials
- Keywords
- Theory of planned behavior, integrated behavior change model, social cognition, physical activity, sedentarism, self-determination theory
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Behaviour Change Based Intervention MaterialsBehavioural
The intervention will be delivered over a three-month period as a series of four zoom hosted workshops, online content, and a moderated social support group. Zoom workshops will last 45 minutes and will target key constructs from the integrated behavior change model. Main topics of the workshops are autonomy Supportive parenting (Week 1), goal setting and outcome beliefs (Week 3), physical activity norms (Week 5), and encouraging self-efficacy and maintenance (Week 8). Following each workshop, participants will receive links to online content that builds on workshop themes, such as messages, worksheets, and reflection tasks. Throughout the trial, participants will be able to participate in social support chat groups to discuss their progress with other members of the intervention group and intervention facilitators.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention Group | Experimental | Immediate intervention group. Participants assigned to the immediate intervention group will be delivered materials over a three-month period as a series of four zoom hosted workshops, online content, and a social support group. Receives: Behavioral: Integrated Behaviour Change Based Intervention Materials |
| Waitlist Control Group | Other | Wait-List Control Group. Participants in the follow-up group will be delivered intervention materials following the third data collection timepoint. Receives: Behavioral: Integrated Behaviour Change Based Intervention Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Godin Leisure time physical activity questionnaire
Self-reported leisure time physical activity as assessed by the Godin Leisure time physical activity questionnaire in all participants. Score range from 0 upwards, with higher scores indicating more leisure time physical activity.
Measured: Assessed at pre-intervention, 3 months (i.e., immediately post intervention), 6 months, and 12 months.
Secondary outcomes (9)
Theory of Planned Behavior - Semantic Differential Attitude Scale
Online questionnaires will be administered to all participants assessing their attitudes towards engaging in leisure time physical activity. Attitude will be assessed using semantic differential scale items scored between 1 and 5, where higher scores are indicative of a more positive attitude towards engaging in physical activity. Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
Measured: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Theory of Planned Behavior - Subjective Norms Likert Scale
Online questionnaires will be administered to all participants assessing their subjective norms around engaging in leisure time physical activity. Subjective norm will be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of a belief that others would want them to engage in physical activity. Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
Measured: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Theory of Planned Behavior - Percieved Behavioral Control Likert Scale
Online questionnaires will be administered to all participants assessing their percieved behavioral control around engaging in leisure time physical activity. Percieved behavioral control will be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of a belief that the participant is able to engage in physical activity if they so wished. Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
Measured: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Theory of Planned Behavior - Intention Likert Scale
Online questionnaires will be administered to all participants assessing their intentions to engage in leisure time physical activity. Intentions will be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of participants intentions and willingness to engage in leisure time physical activity in future. Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
Measured: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Self-Determination Theory - Autonomous Motivation Likert Scale
Online questionnaires will be administered to all participants assessing their level of autonomous motivation to engage in leisure time physical activity. Autonomous motivationwill be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of participants desire to engage in physical activity as they are personally motivated to do so. Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
Measured: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Self-Determination Theory - Percieved Autonomy Support Likert Scale
Online questionnaires will be administered to all participants assessing their level of percieved autonomy support for engaging in leisure time physical activity. Percieved autonomy support will be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of participants belief that they are provided with an enviroment allowing for choice and self-determination for physical activity. Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
Measured: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Triaxial Accelerometer Recordings
For participants assigned to the immediate intervention group, device measured physical activity will be assessed alongside self-reported activity levels using triaxial accelerometer such as the Hooke AM13 or similar. Triaxial accelerometer data will be used to catagorise the amount of time spend engaged in sedentary behaviors, and light, moderate, and vigerous physical activity. Scores for each sedentary behavior, light physical activity, moderate physical activity, and vigerous physical activity time will be recorded as the average number of minutes each day in which each participant spent engaged in that catagory of activity.
Measured: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Focus Group Intervention Evaluation Data - Qualitiative Interview
For participants in the immediate intervention group, the post-intervention (3-months) online questionnaire will include an option for participants to express their interest in attending a 45-minute exit interview on the intervention process. The interviews will be held via Zoom, and audio recorded to accommodate qualitative thematic analysis.
Measured: Assessed at 3 months, immediately post intervention.
Resource Use Data
For participants in the immediate intervention group, their utilisation of intervention recources will be recorded in the form of the number of sessions attended, number of online materials accessed, and the number of messages or reactions sent to the whataspp group.
Measured: Assessed at 3 months, for the time period covering the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start20 Sep 2023
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inactivity/Low Levels of ExerciseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will consist of a wait list control trial, with one group assigned to receive the intervention immediately, and one group assigned to act as a control group before receiving the intervention after data collection is completed. The model also includes a stopping rule, such that 12-month follow-up data will not be collected if there is no significant effect of the intervention on the primary outcome (i.e. leisure time PA) at the 3-month follow-up.
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Hagger, Principal investigator, University of JyvaskylaKeegan Knittle, Principal investigator, University of Jyvaskyla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070038
- Sponsor's protocol ID
- 806/13.00.04.00/2023
- Acronym
- ProAct
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All research components including protocols, materials, de-identified data, and analysis protocols and output, will be publicly shared on a permanent open-access repository (OSF.io).
Publications
Phipps D, Green WT, Aho R, Kettunen E, Biddle S, Hamilton K, Laukkanen A, Aunola K, Chan DK, Hankonen N, Hassandra M, Karkkainen T, Kykyri VL, Polet J, Rhodes R, Ruiz MC, Saakslahti A, Schneider J, Toivonen HM, Lintunen T, Hagger M, Knittle K. A Web-Based Physical Activity Promotion Intervention for Inactive Parent-Child Dyads: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 21;13:e55960. doi: 10.2196/55960.
PubMed 38512336
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Theory-based Intervention to Promote Physical Activity Among Sedentary Parents and Their Children
- ClinicalTrials.gov ID
- NCT06070038
- Acronym / sponsor ID
- ProAct / 806/13.00.04.00/2023
- Keywords
- Theory of planned behavior, integrated behavior change model, social cognition, physical activity, sedentarism, self-determination theory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Oct 2023 (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.
Insufficient physical activity in children and adults is linked to increased risk of physical and mental health conditions. Parents have an important influence on their children's activity, and preliminary aimed at promoting physical activity suggest the family unit as a potentially efficacious means of delivery. However, there is relatively little research examining the efficacy of family interventions aimed at promoting both parents' and children's physical activity. In addition, many family-based interventions are not guided by behavioral theory known to enhance intervention efficacy and reduce variability, and do not target low-active families. This project will therefore develop and test the efficacy of a theory-based behavioral intervention to increase physical activity engagement in low-active children and their parents. The intervention will adopt a randomized waitlist-controlled design with parents and their children allocated to an intervention group that receives theory-based content targeting changes in key behavioral determinants or to a waitlist control group that receives measurement only. The intervention will be delivered to parent-child dyads in a series of four online meetings with a trained facilitator, accompanied by web-based supporting materials, and a moderated social support online chat group. The primary dependent variable will be parents' and children's leisure time physical activity, and secondary outcomes will be device measured physical activity (intervention group only) and measures of key theory-based determinants of physical activity, including autonomous motivation, attitudes, subjective norms, self-efficacy, intentions, and perceived autonomy support. These outcomes will be measured at baseline and at 3, 6, and 12 months post-baseline. Parents and children allocated to the intervention group are expected to exhibit higher levels of physical activity and behavioral determinants. Intervention effects on physical activity change are expected to be mediated by the theory-based determinants, consistent with psychological theory. The project will contribute to research by testing the efficacy of a unique intervention based on behavioral theory expected to be effective in promoting physical activity in low-active parents and their children, and providing guidelines and materials that practitioners in health promotion and public health can use in campaigns and national strategies to promote physical activity in this population.
Detailed description
Low levels of physical activity in adult and youth populations are associated with an increased risk of physical and mental health conditions and reduced quality of life. Conversely, regular activity participation is associated with reduced chronic disease risk and better psychological health and well-being. However, studies indicate that most young people and adults do not achieve recommended levels of physical activity. Physical activity participation also tends to decrease throughout childhood, with steep declines observed during adolescence. Consequently, effective means to promote physical activity participation in child and adult populations are needed. While family-based interventions represent a potentially useful environment for delivering behavioural interventions to promote physical activity in both parents and children, few interventions have been applied in this context. Those that have, tend not to have a strong basis in behavioural theory, often focus on short-term change, and are seldom evaluated systematically.
Within this project, we aim to develop an intervention to promote physical activity in low-active parents and their children. Based on previous research, an integrated model based on multiple theories from behavioural science, particularly social psychology, will guide the development of the intervention in the current project. Specifically, the model draws its predictions from two key behavioural theories: self-determination theory (SDT) and the theory of planned behaviour (TPB), two pre-eminent theoretical approaches that have been applied extensively to predict behaviour and guide interventions in health behaviour contexts.
Evidence suggests that a key approach to family-based behavioural interventions aimed at promoting physical activity in young people and their parents should focus on parent-child dyads, as they provide an efficient means to increase physical activity in both parties. Few studies have systematically evaluated the efficacy of behaviour change methods focused specifically on these kinds of dyad in changing physical activity in family-based interventions and further high-quality evidence is needed. Although the proposed integrated model has generally been used as a basis for interventions in individual contexts, it has not hitherto been adopted as a basis for family-based behaviour change interventions focused on dyads, yet is well placed to be adapted to inform such interventions. The model can also be modified to encompass dyad-focused versions of key determinants identified in the model. For example, the model can be modified to include dyad-based self-efficacy perceptions, a family-based revision of the self-efficacy construct in the model, which reflects perceived confidence in performing the target behaviour together with other dyad members and joint appraisal of goal progress.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will consist of a wait list control trial, with one group assigned to receive the intervention immediately, and one group assigned to act as a control group before receiving the intervention after data collection is completed. The model also includes a stopping rule, such that 12-month follow-up data will not be collected if there is no significant effect of the intervention on the primary outcome (i.e. leisure time PA) at the 3-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Behavioral: Integrated Behaviour Change Based Intervention MaterialsImmediate intervention group. Participants assigned to the immediate intervention group will be delivered materials over a three-month period as a series of four zoom hosted workshops, online content, and a social support group. |
| Waitlist Control Group | Other | Behavioral: Integrated Behaviour Change Based Intervention MaterialsWait-List Control Group. Participants in the follow-up group will be delivered intervention materials following the third data collection timepoint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent does not undertake at least 150 minutes of moderate-intensity (or 75 minutes of vigorous-intensity) physical activity each week.
- Child does not undertake at least 60 minutes of moderate-intensity or vigorous-intensity physical activity each day.
- Child is aged between 8 and 12 years old
Key exclusion criteria (2 listed)
- Parent reports that either they or their child is currently meeting physical activity guidelines at screening.
- Parent states that they or their child has some physical condition that prohibits them from safely participating in physical activity.
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 |
|---|---|---|
| Integrated Behaviour Change Based Intervention MaterialsThe intervention will be delivered over a three-month period as a series of four zoom hosted workshops, online content, and a moderated social support group. Zoom workshops will last 45 minutes and will target key constructs from the integrated behavior change model. Main topics of the workshops are autonomy Supportive parenting (Week 1), goal setting and outcome beliefs (Week 3), physical activity norms (Week 5), and encouraging self-efficacy and maintenance (Week 8). Following each workshop, participants will receive links to online content that builds on workshop themes, such as messages, worksheets, and reflection tasks. Throughout the trial, participants will be able to participate in social support chat groups to discuss their progress with other members of the intervention group and intervention facilitators. | Behavioural | Immediate Intervention Group, Waitlist Control Group |
Primary outcome
Godin Leisure time physical activity questionnaire
Time frame: Assessed at pre-intervention, 3 months (i.e., immediately post intervention), 6 months, and 12 months.
Self-reported leisure time physical activity as assessed by the Godin Leisure time physical activity questionnaire in all participants. Score range from 0 upwards, with higher scores indicating more leisure time physical activity.
9 secondary outcomes
Theory of Planned Behavior - Semantic Differential Attitude Scale
Time frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Theory of Planned Behavior - Subjective Norms Likert Scale
Time frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Theory of Planned Behavior - Percieved Behavioral Control Likert Scale
Time frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Theory of Planned Behavior - Intention Likert Scale
Time frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Self-Determination Theory - Autonomous Motivation Likert Scale
Time frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Self-Determination Theory - Percieved Autonomy Support Likert Scale
Time frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Triaxial Accelerometer Recordings
Time frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
Focus Group Intervention Evaluation Data - Qualitiative Interview
Time frame: Assessed at 3 months, immediately post intervention.
Resource Use Data
Time frame: Assessed at 3 months, for the time period covering the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 38512336Phipps D, Green WT, Aho R, Kettunen E, Biddle S, Hamilton K, Laukkanen A, Aunola K, Chan DK, Hankonen N, Hassandra M, Karkkainen T, Kykyri VL, Polet J, Rhodes R, Ruiz MC, Saakslahti A, Schneider J, Toivonen HM, Lintunen T, Hagger M, Knittle K. A Web-Based Physical Activity Promotion Intervention for Inactive Parent-Child Dyads: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 21;13:e55960. doi: 10.2196/55960.
- Individual participant dataSharing planned: Yes. All research components including protocols, materials, de-identified data, and analysis protocols and output, will be publicly shared on a permanent open-access repository (OSF.io).
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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.
Martin Hagger principal investigator
University of Jyvaskyla
Keegan Knittle principal investigator
University of Jyvaskyla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Behaviour Change Based Intervention Materials in people with Inactivity/Low Levels of Exercise and Inactivity, Physical, run by University of Jyvaskyla at 1 site in Finland.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Oct 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keegan Knittle (+358504698252, keegan.p.knittle@jyu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Godin Leisure time physical activity questionnaire (time frame: Assessed at pre-intervention, 3 months (i.e., immediately post intervention), 6 months, and 12 months.). 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 NCT06070038, which also lists 1 linked publication.
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 6 Oct 2023.