ExerciseNCT04711512
Responses to Physical Activity Messages Among Midlife Adults
An observational study of Exercise and Sedentary Behavior, run by Rowan University at 1 site in United States.
Trial summary
The purpose of this study is to test the short-term effects of physical activity promotion messages designed for midlife adults. These messages are designed to provide information and motivation for physical activity by engaging key social processes, such as social comparison (i.e., self-evaluations relative to… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Sedentary Behavior, Motivation
- What is being tested?
- Encouragement/Support and Social Comparison
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 31 Jan 2022
- Phase
- Observational
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults in midlife with elevated risk for cardiovascular disease (as defined by one or more of the following: smoking, diagnoses of obesity. prediabetes/type 2 diabetes, prehypertension/ hypertension, high cholesterol, or metabolic syndrome)
Who may be able to join
- Adult age 40-60 years old
- Sedentary (<150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity a week)
- One or more cardiovascular risk conditions (i.e., smoking, diagnoses of obesity. prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, metabolic syndrome)
- English language fluency
- Own a personal smartphone
- Have no medical or psychiatric contraindications to changing their physical activity (e.g., current injury, substance use disorder)
Who cannot join
- Not an adult age 40-60 years
- Not sedentary (≥150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity a week)
- No health conditions listed above (smoking, diagnoses of obesity, prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, metabolic syndrome)
- No English language fluency
- Does not own a personal smartphone
- Has medical or psychiatric contraindications to changing their physical activity (e.g., current injury, substance use disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Tailored Digital Intervention to Promote PA and Reduce CVD Risk Among Women in Midlife
The purpose of this study is to test the short-term effects of physical activity promotion messages designed for midlife adults. These messages are designed to provide information and motivation for physical activity by engaging key social processes, such as social comparison (i.e., self-evaluations relative to others).
Read the detailed description
This study will employ an intensive assessment procedure, in which participants are asked to complete several brief surveys per day via mobile device. On some days, as described below, survey content will be assigned with an embedded experimental design, administered via "micro-randomization" (i.e., randomization to receive one of multiple types of content at each momentary report). These methods allow for insight into the immediate effects of different types of content and their accumulated effects over the study period, as participants go about their normal activities.
Participants will complete an initial survey to assess their global and recent experiences (e.g., demographic information, social media use). Participants then will be asked to engage in 7 days of ambulatory data collection (i.e., as they go about their normal daily activities). This includes wearing pedometers to capture PA behavior (steps per day and aerobic-intensity PA) and completing 4 surveys per day via their smartphone.
- For the first 3 days, surveys will assess each participant's preferences and responses to potential message content as they naturally occur. Content has been pre-tested in preliminary work. This will establish participants' baseline behaviors.
- For the following 2 days, participants will be randomized at each survey to either: 1) make an upward PA comparison (to someone engaging in a lot of activity), 2) make a downward PA comparison (to someone engaging in very little activity), or 3) assess a different experience (e.g., received social support).
- For the final 2 days, participants will be randomized at each survey to either: 1) informational messages about ways to increase activity, 2) encouragement to increase their activity in healthy ways, or 3) reminders about their activity goals.
Phases B and C will be counterbalanced, such that half of participants will receive prompts described in Phase B before Phase C, and half will receive prompts described in Phase C before Phase B.
- Conditions
- Exercise, Sedentary Behavior, Motivation
- Being tested
- Encouragement/Support, Social Comparison
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encouragement/SupportBehavioural
Messages that focus on improving self-efficacy and motivation for physical activity
Social ComparisonBehavioural
Messages that provide exposure to another person's physical activity engagement data (for comparison)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm (All Participants) | Within this arm, participants are randomized to one of the interventions described below at each of 4 times per day. Receives: Behavioral: Encouragement/Support; Behavioral: Social Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps
Assessed via pedometer
Measured: up to 24 weeks
Number of minutes in moderate-to-vigorous activity
Assessed via pedometer
Measured: up to 24 weeks
Number of minutes spent sedentary
Assessed via pedometer
Measured: up to 24 weeks
Secondary outcomes (1)
Motivation for physical activity
Assessed via single self-report item
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start8 Apr 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Arigo, Principal investigator, Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711512
- Sponsor's protocol ID
- PRO-2020-146
- Status last verified
- Apr 2022
- First submitted
- 7 Jan 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arigo D, Schumacher LM, Baga K, Mogle JA. Digital, Social Micro-Interventions to Promote Physical Activity Among Midlife Adults With Elevated Cardiovascular Risk: An Ambulatory Feasibility Study With Momentary Randomization. Ann Behav Med. 2024 Nov 16;58(12):845-856. doi: 10.1093/abm/kaae058.
PubMed 39454044
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Tailored Digital Intervention to Promote PA and Reduce CVD Risk Among Women in Midlife
- ClinicalTrials.gov ID
- NCT04711512
- Acronym / sponsor ID
- PRO-2020-146
- Conditions
- Exercise, Sedentary Behavior, Motivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 15 Jan 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.
The purpose of this study is to test the short-term effects of physical activity promotion messages designed for midlife adults. These messages are designed to provide information and motivation for physical activity by engaging key social processes, such as social comparison (i.e., self-evaluations relative to others).
Detailed description
This study will employ an intensive assessment procedure, in which participants are asked to complete several brief surveys per day via mobile device. On some days, as described below, survey content will be assigned with an embedded experimental design, administered via "micro-randomization" (i.e., randomization to receive one of multiple types of content at each momentary report). These methods allow for insight into the immediate effects of different types of content and their accumulated effects over the study period, as participants go about their normal activities.
Participants will complete an initial survey to assess their global and recent experiences (e.g., demographic information, social media use). Participants then will be asked to engage in 7 days of ambulatory data collection (i.e., as they go about their normal daily activities). This includes wearing pedometers to capture PA behavior (steps per day and aerobic-intensity PA) and completing 4 surveys per day via their smartphone.
- For the first 3 days, surveys will assess each participant's preferences and responses to potential message content as they naturally occur. Content has been pre-tested in preliminary work. This will establish participants' baseline behaviors.
- For the following 2 days, participants will be randomized at each survey to either: 1) make an upward PA comparison (to someone engaging in a lot of activity), 2) make a downward PA comparison (to someone engaging in very little activity), or 3) assess a different experience (e.g., received social support).
- For the final 2 days, participants will be randomized at each survey to either: 1) informational messages about ways to increase activity, 2) encouragement to increase their activity in healthy ways, or 3) reminders about their activity goals.
Phases B and C will be counterbalanced, such that half of participants will receive prompts described in Phase B before Phase C, and half will receive prompts described in Phase C before Phase B.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm (All Participants) | – | Behavioral: Encouragement/Support, Behavioral: Social ComparisonWithin this arm, participants are randomized to one of the interventions described below at each of 4 times per day. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults in midlife with elevated risk for cardiovascular disease (as defined by one or more of the following: smoking, diagnoses of obesity. prediabetes/type 2 diabetes, prehypertension/ hypertension, high cholesterol, or metabolic syndrome)
Key inclusion criteria (6 listed)
- Adult age 40-60 years old
- Sedentary (<150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity a week)
- One or more cardiovascular risk conditions (i.e., smoking, diagnoses of obesity. prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, metabolic syndrome)
- English language fluency
- Own a personal smartphone
Key exclusion criteria (6 listed)
- Not an adult age 40-60 years
- Not sedentary (≥150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity a week)
- No health conditions listed above (smoking, diagnoses of obesity, prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, metabolic syndrome)
- No English language fluency
- Does not own a personal smartphone
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 |
|---|---|---|
| Encouragement/SupportMessages that focus on improving self-efficacy and motivation for physical activity | Behavioural | Single Arm (All Participants) |
| Social ComparisonMessages that provide exposure to another person's physical activity engagement data (for comparison) | Behavioural | Single Arm (All Participants) |
Primary outcome
Number of steps
Time frame: up to 24 weeks
Assessed via pedometer
Number of minutes in moderate-to-vigorous activity
Time frame: up to 24 weeks
Assessed via pedometer
Number of minutes spent sedentary
Time frame: up to 24 weeks
Assessed via pedometer
1 secondary outcome
Motivation for physical activity
Time frame: up to 24 weeks
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 28 Apr 2022.
- Derived from this study: PubMed 39454044Arigo D, Schumacher LM, Baga K, Mogle JA. Digital, Social Micro-Interventions to Promote Physical Activity Among Midlife Adults With Elevated Cardiovascular Risk: An Ambulatory Feasibility Study With Momentary Randomization. Ann Behav Med. 2024 Nov 16;58(12):845-856. doi: 10.1093/abm/kaae058.
- Individual participant dataSharing planned: No
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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.
Danielle Arigo principal investigator
Rowan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise and Sedentary Behavior, run by Rowan University at 1 site in United States.
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 6 inclusion and 6 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 28 Apr 2022. 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 United States. 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?
Number of steps (time frame: up to 24 weeks). 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 NCT04711512, 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 28 Apr 2022.