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Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet

16 februari 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

621

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80014
        • Kaiser Permanente - Aurora
    • Oregon
      • Eugene, Oregon, Verenigde Staten, 97403
        • Oregon Research Institute
      • Portland, Oregon, Verenigde Staten, 97227
        • Kaiser Permanente Center for Health Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: dietary counseling via computer
An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
Experimenteel: Counseling only
In this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program.
Gedragsmatig: dietary counseling via nutritionist
A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
Experimenteel: 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.
Gedragsmatig: combined computer and nutritionist
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
Actieve vergelijker: Physical Activity-computer
Participants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only.
Ander: physical activity counseling via computer
An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Kaiser Permanente

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Victor J. Stevens, PhD, Kaiser Permanente

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2005

Primaire voltooiing (Werkelijk)

1 september 2008

Studie voltooiing (Werkelijk)

1 september 2008

Studieregistratiedata

Eerst ingediend

20 september 2005

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2005

Eerst geplaatst (Schatting)

22 september 2005

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 april 2017

Laatste update ingediend die voldeed aan QC-criteria

16 februari 2017

Laatst geverifieerd

1 februari 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • CDR0000441203
  • R01CA098496 (Subsidie/contract van de Amerikaanse NIH)
  • KAISER-R01-CA098496

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