- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02627235
The Deep South IVR-based Active Lifestyle Study (DIAL)
The Deep South IVR-based Active Lifestyle (DIAL) Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- University of Alabama at Birmingham
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Comparatore attivo: Wait List Control
Access to the intervention 12 weeks following baseline assessment.
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Access to DIAL intervention 12 weeks following baseline assessment.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Consumer Satisfaction Survey
Lasso di tempo: 3 months
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Satisfaction with IVR-based system intervention
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3 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
7 Day Physical Activity Recall
Lasso di tempo: 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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6 Minute Walk Test
Lasso di tempo: Baseline and 3 months
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meters walked in 6 minutes
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Baseline and 3 months
|
body mass index
Lasso di tempo: Baseline and 3 months
|
kg/m^2
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Baseline and 3 months
|
waist circumference
Lasso di tempo: Baseline and 3 months
|
cm
|
Baseline and 3 months
|
body impedance analyses
Lasso di tempo: Baseline and 3 months
|
% body fat
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Baseline and 3 months
|
Social Support for exercise scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Self -Efficacy for Exercise Measure
Lasso di tempo: 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
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Accelerometers
Lasso di tempo: Baseline and 3 months
|
minutes/week of moderate intensity or greater physical activity
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Baseline and 3 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Dori Pekmezi, PhD, University of Alabama at Birmingham
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- X131203002
- 1R03CA177538 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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