Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet
16. februar 2017 oppdatert av: Kaiser Permanente
Helping Women Adopt a Cancer Prevention Diet
RATIONALE: Eating a diet high in fruits and vegetables and low in fat may lower the risk of some types of cancer. Dietary counseling may be effective in helping women change to a healthy diet.
PURPOSE: This randomized clinical trial is studying how well individual counseling and/or computer-based counseling work in helping healthy women adopt a cancer prevention diet.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
OBJECTIVES:
- Compare 3-, 12-, and 18-month changes in self-reported daily servings of fruits and vegetables and percent of energy from fat in healthy women undergoing dietary modification intervention comprising in-person individualized counseling vs automated computer-based counseling vs both dietary modification interventions vs automated computer-based physical activity counseling (control).
- Compare the efficacy and long-term effects of these interventions in these participants.
- Compare participant acceptance of these interventions, in terms of the proportion and characteristics (e.g., age and race) of participants who accept the intervention and participate in intervention activities.
- Compare initial dietary change, in terms of dietary habits, socio-demographics, and self-efficacy, in participants undergoing these interventions.
- Compare the maintenance of dietary change, in terms of demographics, self efficacy, and perceived community environmental support, in participants undergoing these interventions.
- Compare the cost of delivering these interventions to these participants.
- Compare the cost of these interventions when used in routine practice.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 4 arms.
- Arm I (in-person individualized dietary modification counseling): Participants undergo in-person individualized counseling in weeks 0 and 3 and receive a phone call by a counselor in weeks 1, 6, and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reducing fat intake to no more than 25% of energy.
- Arm II (automated computer-based dietary modification counseling): Participants undergo automated computer-based counseling in weeks 0 and 3 and receive an automated phone call in weeks 1, 6, and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reducing fat intake to no more than 25% of energy.
- Arm III (in-person individualized and automated computer-based dietary modification counseling): Participants undergo in-person individualized counseling and automated computer-based counseling in weeks 0 and 3 and receive a phone call by a counselor in week 6 and an automated phone call in weeks 1 and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reduce fat intake to no more than 25% of energy.
- Arm IV (automated computer-based physical activity counseling [control]): Participants undergo automated computer-based counseling in weeks 0 and 3 and receive an automated phone call in weeks 1, 6, and 9 about increasing daily physical activity to a moderate amount (20-30 minutes per day).
After study completion, patients are followed at 3, 12, and 18 months.
PROJECTED ACCRUAL: A total of 600 participants (150 per arm) will be accrued for this study within 2 years.
Studietype
Intervensjonell
Registrering (Faktiske)
621
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80014
- Kaiser Permanente - Aurora
-
-
Oregon
-
Eugene, Oregon, Forente stater, 97403
- Oregon Research Institute
-
Portland, Oregon, Forente stater, 97227
- Kaiser Permanente Center for Health Research
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
DISEASE CHARACTERISTICS:
Healthy participant
- Not undergoing care for cancer
- Kaiser Permanente health plan member for at least 2 years
- No current dietary goals
- No diet comprising an average consumption of > 4 combined servings of fruits and vegetables per day and/or fat consumption below 30% of total energy
- No physician-prescribed diets
PATIENT CHARACTERISTICS:
Age
- 30 to 70
Sex
- Female
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Computer Only
Dietary Counseling delivered by interactive computer program, without the addition of individual counseling provided by a health counselor.
This arm tested a completely automated counseling program that did not include personalized behavioral counseling provided by a study staff member.
|
An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
|
Eksperimentell: Counseling only
In this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program.
|
A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
|
Eksperimentell: Combined
In this arm, participants received dietary counseling delivered using both the automated computer program and additional counseling by a study nutritionist.
That is, this arm combined the intervention programs delivered in the other two active intervention arms.
|
An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
|
Aktiv komparator: Physical Activity-computer
Participants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only.
|
An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
Tidsramme: Baseline and 3 months
|
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption.
This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
|
Baseline and 3 months
|
|
Change in Percentage of Fat Consumed
Tidsramme: Baseline and 3 months
|
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption.
This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
|
Baseline and 3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Victor J. Stevens, PhD, Kaiser Permanente
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2005
Primær fullføring (Faktiske)
1. september 2008
Studiet fullført (Faktiske)
1. september 2008
Datoer for studieregistrering
Først innsendt
20. september 2005
Først innsendt som oppfylte QC-kriteriene
20. september 2005
Først lagt ut (Anslag)
22. september 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. februar 2017
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CDR0000441203
- R01CA098496 (U.S. NIH-stipend/kontrakt)
- KAISER-R01-CA098496
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