Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt

Not Applicable

Completed

• Conditions: Physical Activity

• Registration Number: NCT03903874
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This protocol involves a randomized controlled trial (N=240) to test the efficacy of the Deep south Active Lifestyle (DIAL intervention) telephone-based physical activity counseling intervention vs. a wait list condition. Assessments of MVPA and psychosocial variables will occur at baseline, 6, 12, and 18 months.

Primary aim. Test the efficacy of DIAL intervention vs. wait list control. Hypotheses are that the participants receiving DIAL intervention will report significantly greater increases in MVPA (based on 7-Day Physical Activity Recalls, accelerometers) from baseline to 6 and 12 months than the wait list control arm.

Exploratory Aims. Examine 1) Intervention effects on physical performance and psychosocial variables (anxiety, depression, fatigue, sleep disturbance; corroborate self report sleep improvements from pilot with accelerometry); 2) Changes in MVPA from 12-18 months to assess long term (6 months post-intervention) maintenance in the intervention arm and ascertain replicability of intervention effects in wait list control arm; 3) Intervention costs; 4) Potential mediators (social support from family, friends, CHAs, theoretical constructs directly targeted by the intervention) and moderators (education, neighborhood/environmental features) of treatment efficacy; 5) Potential barriers/ facilitators to widespread implementation of DIAL intervention in rural Black belt counties by Deep South Network for Cancer Control.

This proposal tests an intervention which acts on multiple levels of the socio-ecological model and uses IVR technology to enhance the potential for scaling and sustainability for broad use in populations at high risk for sedentary behavior (residents of rural Black counties in the Deep South).

Detailed Description

This protocol involves a randomized controlled trial (N=240) to test the efficacy of the Deep south Active Lifestyle (DIAL intervention) telephone-based physical activity counseling intervention vs. a wait list condition. Assessments of MVPA and psychosocial variables will occur at baseline, 6, 12, and 18 months.

Primary aim. Test the efficacy of DIAL intervention vs. wait list control. Hypotheses are that the participants receiving DIAL intervention will report significantly greater increases in MVPA (based on 7-Day Physical Activity Recalls, accelerometers) from baseline to 6 and 12 months than the wait list control arm.

Exploratory Aims. Examine 1) Intervention effects on physical performance and psychosocial variables (anxiety, depression, fatigue, sleep disturbance; corroborate self report sleep improvements from pilot with accelerometry); 2) Changes in MVPA from 12-18 months to assess long term (6 months post-intervention) maintenance in the intervention arm and ascertain replicability of intervention effects in wait list control arm; 3) Intervention costs; 4) Potential mediators (social support from family, friends, CHAs, theoretical constructs directly targeted by the intervention) and moderators (education, neighborhood/environmental features) of treatment efficacy; 5) Potential barriers/ facilitators to widespread implementation of DIAL intervention in rural Black belt counties by Deep South Network for Cancer Control.

This proposal tests an intervention which acts on multiple levels of the socio-ecological model and uses IVR technology to enhance the potential for scaling and sustainability for broad use in populations at high risk for sedentary behavior (residents of rural Black counties in the Deep South).

Study Timeline

• Study First Submitted: 2019-03-31
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Study Start: 2020-09-09
• Status Verified: 2024-11
• Primary Completion: 2024-11-26
• Study Completion: 2024-11-26
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Insufficiently active (engaging in MVPA < 60 minutes per week)
• Residents of participating rural Black Belt counties (Dallas, Marengo, Choctaw, Sumter, Hale, Greene)
• BMI 18.5-45
• Able to speak and read English
• Willing to be randomized to either study arm and adhere to study protocol
• Able to regularly access a telephone (own a cell phone or work/home landline) to complete IVR calls

Exclusion Criteria

• Serious medical conditions that would make physical activity unsafe (history of heart disease, myocardial infarction, angina, stroke, orthopedic conditions which limit mobility),
• Planning to move from the area within the next 18 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
changes in physical activity (as measured by 7-Day Physical Activity Recall interview)	baseline, 6 months, 12 months, 18 months	This interviewer-administered instrument estimates min/week of physical activity

Trial Locations

Locations (1)

University of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States