The Study of Automated Telephone Programs for the Maintenance of Dietary Change
1. juli 2015 opdateret af: Robert H. Friedman
Trial of 2 TeleComputer Diet Change Maintenance Programs
The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes.
This study will deliver a health program using an automated telephone system.
The programs will be designed to help individuals maintain a healthy diet change for a lifetime.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
RCT is completed.
However, the eligibility was 18 y/o or greater and living in Greater Boston area.
The participants used an evidenced based dietary intervention for 3 months and then were randomized to 1 of 3 arms.
Those in the experimental arm received a 6 mo intervention based on social cognitive theory or goal systems theory.
The intervention was designed to help the participants maintain previously achieved changes in the their diet, e.g., fruits and vegetables.
The outcome measures are fruit and vegetable consumption as measured by servings on multiple dietary measures as well as a 24 hr dietary recall.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1049
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Consume fewer than 5 fruits and vegetables per day.
- Understand conversational English
- Have the ability to use a telephone without assistance
Exclusion Criteria:
- Under 18 years of age
- Diagnosis of a health condition for which dietary recommendations in the would be contraindicated,
- Have cognitive impairment
- Have a terminal illness, recent myocardial infarction, current or former diagnosis of an eating disorder, pregnancy
- Consume > 5 servings of fruit and vegetable per day, or
- Plan to move away from the Boston area in less than 30 months.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: social cognitive theory
This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption.
The intervention components were based on social cognitive theory and delivered by an automated telephone system.
|
6 mo dietary intervention.
This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption.
The intervention components were based on social cognitive theory.
Andre navne:
|
|
Eksperimentel: Goal Systems Theory
This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption.
The intervention components were based on goal systems theory.
|
This arm received a 6 mo diet intervention designed to maintain changes in fruit and vegetable consumption.
The intervention components were based on goal systems theory and delivered by an automated telephone system.
Andre navne:
|
|
Ingen indgriben: Comparison group
comparison group
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption.
Tidsramme: July 2006-July 2009
|
July 2006-July 2009
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.
Tidsramme: July 2006-July 2009
|
July 2006-July 2009
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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 2006
Primær færdiggørelse (Faktiske)
1. august 2010
Studieafslutning (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først indsendt
6. september 2005
Først indsendt, der opfyldte QC-kriterier
6. september 2005
Først opslået (Skøn)
8. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2015
Sidst verificeret
1. juni 2011
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- R01CA105832-02 (U.S. NIH-bevilling/kontrakt)
- National Cancer Institute (Anden identifikator: National Cancer Institute)
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 .