Real-time Behavioral Interventions

Not Applicable

• Conditions: Comorbidities and Coexisting Conditions; Aging; Cancer
• Interventions: Behavioral: Just-in-Time Adaptive Intervention

• Registration Number: NCT04457128
• Lead Sponsor: University of Alabama, Tuscaloosa

Brief 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.

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 Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-06-29
• Status Verified: 2020-07
• Study First Posted: 2020-07-07
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09
• Study Start: 2021-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Secular Image	Just-in-Time Adaptive Intervention	Secular Image
Secular message	Just-in-Time Adaptive Intervention	secular messages
Non-secular image	Just-in-Time Adaptive Intervention	non-secular images
Non-secular message	Just-in-Time Adaptive Intervention	non-secular messages

Primary Outcome Measures

Name	Time	Method
Usage	16 weeks	To percentage of time participants were complying with the study protocol
The Usage, Satisfaction, Ease of use Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Change in light-intensity physical activity	Week 0 and Week 16	Accelerometer determined activity
Change in sedentary time	Week 0 and Week 16	Accelerometer determined breaks in inactivity during waking hours