Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

30. december 2019 opdateret af: Dorothy Pekmezi, PhD, University of Alabama at Birmingham

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

Studieoversigt

Status

Afsluttet

Betingelser

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

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
meters walked in 6 minutes
Baseline and 3 months
body mass index
Tidsramme: Baseline and 3 months
kg/m^2
Baseline and 3 months
waist circumference
Tidsramme: Baseline and 3 months
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
range=0-65 for both friends and family subscales, with higher scores indicating more social support
Baseline, 1 month, 2 months, and 3 months
Outcome expectations scale
Tidsramme: Baseline, 1 month, 2 months, and 3 months
range= 1-5, with higher scores representing more outcome expectations
Baseline, 1 month, 2 months, and 3 months
Physical Activity Enjoyment scale
Tidsramme: Baseline, 1 month, 2 months, and 3 months
range=18-126, with higher scores indicating more enjoyment
Baseline, 1 month, 2 months, and 3 months
Self -Efficacy for Exercise Measure
Tidsramme: Baseline, 1 month, 2 months, and 3 months
range= 1-5, with higher scores representing more self-efficacy
Baseline, 1 month, 2 months, and 3 months
Accelerometers
Tidsramme: Baseline and 3 months
minutes/week of moderate intensity or greater physical activity
Baseline and 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Dori Pekmezi, PhD, University of Alabama at Birmingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2015

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. december 2019

Datoer for studieregistrering

Først indsendt

8. december 2015

Først indsendt, der opfyldte QC-kriterier

8. december 2015

Først opslået (Skøn)

10. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • X131203002
  • 1R03CA177538 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fysisk aktivitet

Kliniske forsøg med DIAL

3
Abonner