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

NCT03903874 | Completed Results

• 2 other identifiers: IRB-300003238R01CA233550
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

• Changes in Moderate-vigorous Intensity Physical Activity

  Changes in min/week of moderate-vigorous intensity physical activity from baseline to 6 months, based on 7-Day Physical Activity Recall interviews

  baseline, 6 months, 12 months, 18 months

Study Arms (2)

DIAL intervention

EXPERIMENTAL

Deep south Interactive voice response system Active Lifestyle (DIAL) intervention. Participants will receive 12 months of automated physical activity phone counseling. Participants will report their physical activity to the IVR system each day for 3 months, twice/week in months 3-6, and once/week in months 6-12 and receive progress feedback via IVR system, along with community health worker support.

Behavioral: Deep south Interactive voice response system supported Active Lifestyle (DIAL)

Wait List Control

NO INTERVENTION

The wait list control participants will be instructed to maintain their normal routine until completion of the 6-month assessments and then receive the same 12-month DIAL intervention. To maintain engagement, these participants will be involved in monthly lunch and learns, focus groups, etc on cancer topics other than PA (e.g., screening) during the wait period.

Interventions

Deep south Interactive voice response system supported Active Lifestyle (DIAL) BEHAVIORAL

12 months of automated telephone physical activity counseling with community health worker support

DIAL intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama At Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Brown NI, Powell MA, Baskin M, Oster R, Demark-Wahnefried W, Hardy C, Pisu M, Thirumalai M, Townsend S, Neal WN, Rogers LQ, Pekmezi D. Design and Rationale for the Deep South Interactive Voice Response System-Supported Active Lifestyle Study: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 May 25;10(5):e29245. doi: 10.2196/29245.

  PMID: 34032575 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Dori Pekmezi
• Organization: University of Alabama at Birmingham

dpekmezi@uab.edu

205-975-8061

Study Officials

• Dorothy Pekmezi, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessment staff will be blind to condition
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 4, 2019
• Study Start: September 9, 2020
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: April 21, 2026
• Results First Posted: October 29, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)