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The Deep South IVR-based Active Lifestyle Study

The Deep South IVR-based Active Lifestyle (DIAL) Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02627235
Acronym
DIAL
Enrollment
62
Registered
2015-12-10
Start date
2015-07-31
Completion date
2019-12-31
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

Physical Activity, Cancer Prevention

Brief summary

This pilot study represents an initial foray into delivering an Individual Voice Response-based (IVR) physical activity intervention for cancer risk among sedentary adults in the Deep South.

Detailed description

60 participants will receive the DIAL intervention or Wait List Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected and measured at baselines and 12-weeks. DIAL Intervention: The physical activity intervention is based on Social Cognitive Theory and emphasizes behavioral strategies for increasing activity levels (i.e., goal setting, self-monitoring, problem solving barriers, increasing social support, rewarding oneself for meeting physical activity goals) and includes daily activity reporting via an Individual Voice Response (IVR) system that allows computer-assisted interaction with participants by telephone. Computer expert system feedback on physical activity progress will be based on participants' reported daily step counts and \>moderate intensity PA . In addition to IVR system feedback, participants will receive monthly graphic-based feedback letters delivered by mail. Messages will encourage incremental increases until national PA guidelines are reached and provide specific information on cancer risk reduction (In the past 7 days, you called the DIAL study line all 7 days and reported engaging in 80 minutes of moderate intensity PA. The national guidelines call for \>150 min/week of moderate intensity PA so you are well on your way. Keep up the good work. Make small increases in PA each week until you reach that goal. Remember: 30-60 min/day of moderate-vigorous intensity PA may significantly lower your risk of breast and colon cancer). To improve self-efficacy, social support, outcome expectations, and perceived enjoyment, we will assess these variables at baseline, 30, 60, and 90 days. Responses will be used to select appropriate tailored feedback modules (for low self-efficacy score, You do not seem confident about your ability to exercise. Often trying to fit in some PA on top of the demands of work and family can be a challenge. Try making time for a 10 minute walk 1-2 days this week. It will help build confidence about your ability to fit PA into your lifestyle.) Finally, participants will receive access to problem solving modules, addressing PA barriers identified by the community during formative research (lack of time, negative outcome expectations, enjoyment, social support, see table below). Module options will be rotated and constantly updated to keep participants engaged. Wait List Control Condition: Will receive the intervention after 12 weeks following baseline assessments.

Interventions

BEHAVIORALDIAL

The physical activity intervention is based on Social Cognitive Theory and includes feedback on physical activity progress via IVR system and monthly graphic-based feedback letters delivered in the mail. Messages will encourage incremental increases until national PA guidelines are reached and provide specific information on cancer risk reduction.

Access to DIAL intervention 12 weeks following baseline assessment.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 21 years or older * Underactive (\<60 min/week moderate PA) * Able to speak/read English * Willing to be assigned to either condition * Access to a telephone * Not planning to move from the area in the next 4 months * Healthy (BMI 18.5-45; No history of heart disease, myocardial infarction, angina, stroke, or orthopedic conditions which limit mobility, or any serious medical condition that would make physical activity unsafe; no psychiatric hospitalization in past 3 years).

Design outcomes

Primary

MeasureTime frameDescription
Consumer Satisfaction Survey3 monthsSatisfaction with IVR-based system intervention

Secondary

MeasureTime frameDescription
6 Minute Walk TestBaseline and 3 monthsmeters walked in 6 minutes
body mass indexBaseline and 3 monthskg/m\^2
waist circumferenceBaseline and 3 monthscm
body impedance analysesBaseline and 3 months% body fat
7 Day Physical Activity RecallBaseline and 3 monthsminutes/week of moderate intensity or greater physical activity
Outcome expectations scaleBaseline, 1 month, 2 months, and 3 monthsrange= 1-5, with higher scores representing more outcome expectations
Physical Activity Enjoyment scaleBaseline, 1 month, 2 months, and 3 monthsrange=18-126, with higher scores indicating more enjoyment
Self -Efficacy for Exercise MeasureBaseline, 1 month, 2 months, and 3 monthsrange= 1-5, with higher scores representing more self-efficacy
AccelerometersBaseline and 3 monthsminutes/week of moderate intensity or greater physical activity
Social Support for exercise scaleBaseline, 1 month, 2 months, and 3 monthsrange=0-65 for both friends and family subscales, with higher scores indicating more social support

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026