Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet
16. Februar 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
621
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80014
- Kaiser Permanente - Aurora
-
-
Oregon
-
Eugene, Oregon, Vereinigte Staaten, 97403
- Oregon Research Institute
-
Portland, Oregon, Vereinigte Staaten, 97227
- Kaiser Permanente Center for Health Research
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
30 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Aktiver 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Victor J. Stevens, PhD, Kaiser Permanente
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2005
Primärer Abschluss (Tatsächlich)
1. September 2008
Studienabschluss (Tatsächlich)
1. September 2008
Studienanmeldedaten
Zuerst eingereicht
20. September 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. September 2005
Zuerst gepostet (Schätzen)
22. September 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. April 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Februar 2017
Zuletzt verifiziert
1. Februar 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- CDR0000441203
- R01CA098496 (US NIH Stipendium/Vertrag)
- KAISER-R01-CA098496
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .