- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02627235
The Deep South IVR-based Active Lifestyle Study (DIAL)
The Deep South IVR-based Active Lifestyle (DIAL) Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: DIAL Intervention
The physical activity intervention 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 IVR-system call feedback and monthly graphic-based feedback delivered in the mail.
In addition, social support, outcome expectations and perceived physical activity enjoyment variables will be assessed at baseline, 30, 60, and 90 days.
Responses will be used to select appropriate tailored feedback modules.
|
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.
|
Aktiv komparator: Wait List Control
Access to the intervention 12 weeks following baseline assessment.
|
Access to DIAL intervention 12 weeks following baseline assessment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Consumer Satisfaction Survey
Tidsramme: 3 months
|
Satisfaction with IVR-based system intervention
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
7 Day Physical Activity Recall
Tidsramme: Baseline and 3 months
|
minutes/week of moderate intensity or greater physical activity
|
Baseline and 3 months
|
6 Minute Walk Test
Tidsramme: Baseline and 3 months
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meters walked in 6 minutes
|
Baseline and 3 months
|
body mass index
Tidsramme: Baseline and 3 months
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kg/m^2
|
Baseline and 3 months
|
waist circumference
Tidsramme: Baseline and 3 months
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cm
|
Baseline and 3 months
|
body impedance analyses
Tidsramme: Baseline and 3 months
|
% body fat
|
Baseline and 3 months
|
Social Support for exercise scale
Tidsramme: Baseline, 1 month, 2 months, and 3 months
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range=0-65 for both friends and family subscales, with higher scores indicating more social support
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Baseline, 1 month, 2 months, and 3 months
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Outcome expectations scale
Tidsramme: Baseline, 1 month, 2 months, and 3 months
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range= 1-5, with higher scores representing more outcome expectations
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Baseline, 1 month, 2 months, and 3 months
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Physical Activity Enjoyment scale
Tidsramme: Baseline, 1 month, 2 months, and 3 months
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range=18-126, with higher scores indicating more enjoyment
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Baseline, 1 month, 2 months, and 3 months
|
Self -Efficacy for Exercise Measure
Tidsramme: Baseline, 1 month, 2 months, and 3 months
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range= 1-5, with higher scores representing more self-efficacy
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Baseline, 1 month, 2 months, and 3 months
|
Accelerometers
Tidsramme: Baseline and 3 months
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minutes/week of moderate intensity or greater physical activity
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Baseline and 3 months
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dori Pekmezi, PhD, University of Alabama at Birmingham
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- X131203002
- 1R03CA177538 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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