University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT02627235
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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Notify Me21 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: 3 months
Satisfaction with IVR-based system intervention
Time frame: Baseline and 3 months
minutes/week of moderate intensity or greater physical activity
Time frame: Baseline and 3 months
meters walked in 6 minutes
Time frame: Baseline and 3 months
kg/m^2
Time frame: Baseline and 3 months
cm
Time frame: Baseline and 3 months
% body fat
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
Time frame: Baseline, 1 month, 2 months, and 3 months
range= 1-5, with higher scores representing more outcome expectations
Time frame: Baseline, 1 month, 2 months, and 3 months
range=18-126, with higher scores indicating more enjoyment
Time frame: Baseline, 1 month, 2 months, and 3 months
range= 1-5, with higher scores representing more self-efficacy
Time frame: Baseline and 3 months
minutes/week of moderate intensity or greater physical activity
University of Alabama at Birmingham
Other
The Deep South IVR-based Active Lifestyle (DIAL) Study
Acronym: DIAL
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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