Real-time Behavioral Interventions

Cancer Clinical Trial

Official title:

Just-in-Time Adaptive Intervention to Reduce Sedentary Behavior

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04457128
• Other study ID #: 20-03-3472
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: July 2020
• Source: University of Alabama, Tuscaloosa
• Contact: Raheem Paxton, PhD
• Phone: 205-348-6857
• Email: rpaxton[@]ua.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cancer
• Comorbidities and Coexisting Conditions

Intervention

Behavioral:
• Just-in-Time Adaptive Intervention
Randomized factorial design

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage	To percentage of time participants were complying with the study protocol	16 weeks
Primary	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.	16 weeks
Secondary	Change in sedentary time	Accelerometer determined breaks in inactivity during waking hours	Week 0 and Week 16
Secondary	Change in light-intensity physical activity	Accelerometer determined activity	Week 0 and Week 16