CancerNCT04457128
Real-time Behavioral Interventions
A study testing Just-in-Time Adaptive Intervention in people with Cancer and Aging, run by University of Alabama, Tuscaloosa.
Trial summary
The goal of this study is to adapt an evidence-based sedentary behavior reduction intervention for men and women living in Alabama and determine its feasibility, acceptance, and limited efficacy. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Aging, Comorbidities and Coexisting Conditions
- What is being tested?
- Just-in-Time Adaptive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Aug 2021
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 50 to 75 years old at study enrollment;
- Currently living in Alabama;
- Community-dwelling (i.e., not living in an assisted living facility or nursing home);
- Having access to the internet and a smart phone;
- Able to perform light-intensity physical activity (i.e., walking);
- English speaking;
- Willing to consent to study procedure.
Who cannot join
- Reporting more than 60 minutes of purposeful physical activity per week;
- Have an unstable mental condition that prevention study activities. Determined by the Physician Health questionnaire.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Just-in-Time Adaptive Intervention to Reduce Sedentary Behavior
The goal of this study is to adapt an evidence-based sedentary behavior reduction intervention for men and women living in Alabama and determine its feasibility, acceptance, and limited efficacy.
Read the detailed description
The goal of this study is to adapt an evidence-based sedentary behavior reduction intervention for men and women living in Alabama and determine its feasibility, acceptance, and limited efficacy. Community-based Participatory Research methods will be used to adapt an evidence-based curriculum. The adapted curriculum will be delivered via print-based materials and a mobile phone app developed by an external collaborator.
- Conditions
- Cancer, Aging, Comorbidities and Coexisting Conditions
- Being tested
- Just-in-Time Adaptive Intervention
- Keywords
- physical activity, ecological momentary assessment, health-related quality of life, Just-in-time adaptive intervention
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just-in-Time Adaptive InterventionBehavioural
Randomized factorial design
| Study group | Role | What they receive |
|---|---|---|
| Secular Image | Experimental | Secular Image Receives: Behavioral: Just-in-Time Adaptive Intervention |
| Non-secular image | Experimental | non-secular images Receives: Behavioral: Just-in-Time Adaptive Intervention |
| Secular message | Experimental | secular messages Receives: Behavioral: Just-in-Time Adaptive Intervention |
| Non-secular message | Experimental | non-secular messages Receives: Behavioral: Just-in-Time Adaptive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage
To percentage of time participants were complying with the study protocol
Measured: 16 weeks
The Usage, Satisfaction, Ease of use Questionnaire
Questionnaire that assesses usage, satisfaction, and ease of use of technology. Each subscale has a maximum score of 20, with higher scores indicating a better outcome.
Measured: 16 weeks
Secondary outcomes (2)
Change in sedentary time
Accelerometer determined breaks in inactivity during waking hours
Measured: Week 0 and Week 16
Change in light-intensity physical activity
Accelerometer determined activity
Measured: Week 0 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jan 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Factorial
- Model description
- Micro-randomized trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Raheem Paxton, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457128
- Sponsor's protocol ID
- 20-03-3472
- Status last verified
- Jul 2020
- First submitted
- 3 Apr 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No at this time
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just-in-Time Adaptive Intervention to Reduce Sedentary Behavior
- ClinicalTrials.gov ID
- NCT04457128
- Acronym / sponsor ID
- 20-03-3472
- Conditions
- Cancer, Aging, Comorbidities and Coexisting Conditions
- Keywords
- physical activity, ecological momentary assessment, health-related quality of life, Just-in-time adaptive intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 7 Jul 2020 (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.
The goal of this study is to adapt an evidence-based sedentary behavior reduction intervention for men and women living in Alabama and determine its feasibility, acceptance, and limited efficacy.
Detailed description
The goal of this study is to adapt an evidence-based sedentary behavior reduction intervention for men and women living in Alabama and determine its feasibility, acceptance, and limited efficacy. Community-based Participatory Research methods will be used to adapt an evidence-based curriculum. The adapted curriculum will be delivered via print-based materials and a mobile phone app developed by an external collaborator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Micro-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Secular Image | Experimental | Behavioral: Just-in-Time Adaptive InterventionSecular Image |
| Non-secular image | Experimental | Behavioral: Just-in-Time Adaptive Interventionnon-secular images |
| Secular message | Experimental | Behavioral: Just-in-Time Adaptive Interventionsecular messages |
| Non-secular message | Experimental | Behavioral: Just-in-Time Adaptive Interventionnon-secular messages |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • 50 to 75 years old at study enrollment;
Key exclusion criteria (2 listed)
- Reporting more than 60 minutes of purposeful physical activity per week;
- Have an unstable mental condition that prevention study activities. Determined by the Physician Health questionnaire.
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 |
|---|---|---|
| Just-in-Time Adaptive InterventionRandomized factorial design | Behavioural | Non-secular image, Non-secular message, Secular Image, Secular message |
Primary outcome
Usage
Time frame: 16 weeks
To percentage of time participants were complying with the study protocol
The Usage, Satisfaction, Ease of use Questionnaire
Time frame: 16 weeks
Questionnaire that assesses usage, satisfaction, and ease of use of technology. Each subscale has a maximum score of 20, with higher scores indicating a better outcome.
2 secondary outcomes
Change in sedentary time
Time frame: Week 0 and Week 16
Change in light-intensity physical activity
Time frame: Week 0 and Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: No. No at this time
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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.
Raheem Paxton, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Just-in-Time Adaptive Intervention in people with Cancer and Aging, run by University of Alabama, Tuscaloosa.
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 7 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Raheem Paxton, PhD (205-348-6857, rpaxton@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.