N/A
Completed N=245
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
Physical Activity
Source: ClinicalTrials.gov NCT03903874 ↗
Enrolled (actual)
245
Serious AEs
2.9%
Results posted
Oct 2025
Primary outcomePrimary: Changes in Moderate-vigorous Intensity Physical Activity — 67.35; 4.09 min/week of physical activity
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Moderate-vigorous Intensity Physical Activity |
67.35; 4.09 | — |
Eligibility Criteria
Inclusion Criteria
- Insufficiently active (engaging in MVPA < 60 minutes per week)
- Residents of participating rural Black Belt counties (Dallas, Marengo, Choctaw, Sumter, Hale, Greene)
- 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.
Data sourced from ClinicalTrials.gov (NCT03903874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.