Real-time Behavioral Interventions

November 5, 2020 updated by: University of Alabama, Tuscaloosa

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

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

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

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • 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.

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Secular Image
Behavioral: Just-in-Time Adaptive Intervention
Randomized factorial design
EXPERIMENTAL: Non-secular image
non-secular images
Behavioral: Just-in-Time Adaptive Intervention
Randomized factorial design
EXPERIMENTAL: Secular message
secular messages
Behavioral: Just-in-Time Adaptive Intervention
Randomized factorial design
EXPERIMENTAL: Non-secular message
non-secular messages
Behavioral: Just-in-Time Adaptive Intervention
Randomized factorial design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage
Time Frame: 16 weeks
To percentage of time participants were complying with the study protocol
16 weeks
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sedentary time
Time Frame: Week 0 and Week 16
Accelerometer determined breaks in inactivity during waking hours
Week 0 and Week 16
Change in light-intensity physical activity
Time Frame: Week 0 and Week 16
Accelerometer determined activity
Week 0 and Week 16

Collaborators and Investigators

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

Sponsor

University of Alabama, Tuscaloosa

Collaborators

University of Alabama at Birmingham

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 (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

August 31, 2021

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (ACTUAL)

July 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-03-3472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No at this time

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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