Physical ActivityDIALNCT03903874
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
A study testing Deep south Interactive voice response system supported Active Lifestyle (DIAL) in people with Physical Activity, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Deep south Interactive voice response system supported Active Lifestyle (DIAL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 26 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama At Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Deep south Interactive voice response system supported Active Lifestyle (DIAL)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep south Interactive voice response system supported Active Lifestyle (DIAL)Behavioural
12 months of automated telephone physical activity counseling with community health worker support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start9 Sep 2020
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Dorothy Pekmezi, PhD, University of Alabama at Birmingham
- Investigators
- Dorothy Pekmezi, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903874
- Sponsor's protocol ID
- IRB-300003238
- Other IDs
- R01CA233550
- Acronym
- DIAL
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2019
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pekmezi D, Thirumalai M, Brown NI, Oster RA, Bowman T, Baskin M, Niranjan S, Pisu M, MacCarthy S, Cole WW, Parrish K, Demark-Wahnefried W. The Deep South Interactive Voice Response (IVR) System-Supported Active Lifestyle (DIAL) Intervention Shows Efficacy in Rural Alabama: An RCT. Am J Prev Med. 2026 May 27;71(6):108440. doi: 10.1016/j.amepre.2026.108440. Online ahead of print.
PubMed 42208699Brown 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.
PubMed 34032575
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
- ClinicalTrials.gov ID
- NCT03903874
- Acronym / sponsor ID
- DIAL / IRB-300003238
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIAL intervention | Experimental | Behavioral: Deep south Interactive voice response system supported Active Lifestyle (DIAL)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep south Interactive voice response system supported Active Lifestyle (DIAL)12 months of automated telephone physical activity counseling with community health worker support | Behavioural | DIAL intervention |
Primary outcome
Changes in Moderate-vigorous Intensity Physical Activity
Time frame: baseline, 6 months, 12 months, 18 months
Changes in min/week of moderate-vigorous intensity physical activity from baseline to 6 months, based on 7-Day Physical Activity Recall interviews
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42208699Pekmezi D, Thirumalai M, Brown NI, Oster RA, Bowman T, Baskin M, Niranjan S, Pisu M, MacCarthy S, Cole WW, Parrish K, Demark-Wahnefried W. The Deep South Interactive Voice Response (IVR) System-Supported Active Lifestyle (DIAL) Intervention Shows Efficacy in Rural Alabama: An RCT. Am J Prev Med. 2026 May 27;71(6):108440. doi: 10.1016/j.amepre.2026.108440. Online ahead of print.
- Derived from this study: PubMed 34032575Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothy Pekmezi, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep south Interactive voice response system supported Active Lifestyle (DIAL) in people with Physical Activity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Moderate-vigorous Intensity Physical Activity (time frame: baseline, 6 months, 12 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903874, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.