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Completed

NCT Number: NCT02627235

The Deep South IVR-based Active Lifestyle Study

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DIAL

Behavioral

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.

Wait list control

Behavioral

Access to DIAL intervention 12 weeks following baseline assessment.

Primary outcomes

  1. Consumer Satisfaction Survey

    Time frame: 3 months

    Satisfaction with IVR-based system intervention

Secondary outcomes

  1. 7 Day Physical Activity Recall

    Time frame: Baseline and 3 months

    minutes/week of moderate intensity or greater physical activity

  2. 6 Minute Walk Test

    Time frame: Baseline and 3 months

    meters walked in 6 minutes

  3. body mass index

    Time frame: Baseline and 3 months

    kg/m^2

  4. waist circumference

    Time frame: Baseline and 3 months

    cm

  5. body impedance analyses

    Time frame: Baseline and 3 months

    % body fat

  6. Social Support for exercise scale

    Time frame: Baseline, 1 month, 2 months, and 3 months

    range=0-65 for both friends and family subscales, with higher scores indicating more social support

  7. Outcome expectations scale

    Time frame: Baseline, 1 month, 2 months, and 3 months

    range= 1-5, with higher scores representing more outcome expectations

  8. Physical Activity Enjoyment scale

    Time frame: Baseline, 1 month, 2 months, and 3 months

    range=18-126, with higher scores indicating more enjoyment

  9. Self -Efficacy for Exercise Measure

    Time frame: Baseline, 1 month, 2 months, and 3 months

    range= 1-5, with higher scores representing more self-efficacy

  10. Accelerometers

    Time frame: Baseline and 3 months

    minutes/week of moderate intensity or greater physical activity

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: DIAL

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Dec 10, 2015
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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