Responses to Physical Activity Messages Among Midlife Adults

April 27, 2022 updated by: Rowan University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

A. 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.

B. 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).

C. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Glassboro, New Jersey, United States, 08028
        • Rowan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Single Arm (All Participants)
Within this arm, participants are randomized to one of the interventions described below at each of 4 times per day.
Behavioral: Encouragement/Support
Messages that focus on improving self-efficacy and motivation for physical activity
Behavioral: Social Comparison
Messages that provide exposure to another person's physical activity engagement data (for comparison)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of steps
Time Frame: up to 24 weeks
Assessed via pedometer
up to 24 weeks
Number of minutes in moderate-to-vigorous activity
Time Frame: up to 24 weeks
Assessed via pedometer
up to 24 weeks
Number of minutes spent sedentary
Time Frame: up to 24 weeks
Assessed via pedometer
up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Motivation for physical activity
Time Frame: up to 24 weeks
Assessed via single self-report item
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rowan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danielle Arigo, Rowan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-2020-146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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