- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528615
Testing the Effectiveness of Coping With Cancer in the Kitchen (CCK)
August 24, 2020 updated by: American Institute for Cancer Research
A Randomized Controlled Trial to Test the Effectiveness of Coping With Cancer in the Kitchen, a Nutrition Education Program From Diagnosis and Beyond
The study was a two-arm, randomized controlled trial in which cancer survivors were evenly assigned to either receive the 8-week CCK in-person nutrition intervention immediately or to become the control group that received a selection of CCK printed materials.
The aim was to test the effectiveness of CCK for implementing a healthy plant-based diet and improving quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Cancer Support Community Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
-
Exclusion Criteria:
- Need to have ever been diagnosed with cancer to be eligible
- Need to have not participated in a Living Plate cooking program
- Need to be able to attend at least seven of the eight sessions of the series with mandatory first and last sessions
- Need to have completed active cancer treatment (not including hormonal or other similar agents, e.g., tamoxifen)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CCK In-Person Sessions
This group received the in-person CCK intervention.
|
This group attended eight weeks of nutrition education-focused experiential learning.
|
Active Comparator: CCK Printed Materials
This group received select printed CCK materials.
|
This group did not attend any in-person sessions and was only provided with select CCK written materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge about the role of a plant-based diet in cancer risk reduction
Time Frame: 9 weeks
|
Change from baseline in knowledge about role of consuming a predominantly plant-based diet and cancer risk.
Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with six custom items developed by the research team, e.g., "I understand the benefits of consuming whole grains versus processed grains".
A composite score was calculated as the average of the 6 ratings (range 1-5; Cronbach's alpha=.80).
|
9 weeks
|
Knowledge about the role of a plant-based diet in cancer risk reduction
Time Frame: 15 weeks
|
Change from baseline in knowledge about role of consuming a predominantly plant-based diet and cancer risk.
Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with six custom items developed by the research team, e.g., "I understand the benefits of consuming whole grains versus processed grains".
A composite score was calculated as the average of the 6 ratings (range 1-5; Cronbach's alpha=.80).
|
15 weeks
|
Confidence preparing a variety of plant-based foods
Time Frame: 9 weeks
|
Change from baseline in confidence to prepare a variety of plant-based foods.
Participants indicated "How sure are you that you could prepare the foods listed below in a tasty way?" (1 = Very unsure; 5 = Very sure).
The 14-item scale included: 4 whole grains; 4 beans, seeds and legumes; 3 green leafy vegetables; and 3 mixed foods, e.g.
healthy one-pot meals.
A composite score was calculated as the average of the 14 items (range 1-5; Cronbach's alpha=.75).
|
9 weeks
|
Confidence preparing a variety of plant-based foods
Time Frame: 15 weeks
|
Change from baseline in confidence to prepare a variety of plant-based foods.
Participants indicated "How sure are you that you could prepare the foods listed below in a tasty way?" (1 = Very unsure; 5 = Very sure).
The 14-item scale included: 4 whole grains; 4 beans, seeds and legumes; 3 green leafy vegetables; and 3 mixed foods, e.g.
healthy one-pot meals.
A composite score was calculated as the average of the 14 items (range 1-5; Cronbach's alpha=.75).
|
15 weeks
|
Skills to practice a plant-based diet
Time Frame: 9 weeks
|
Change from baseline in skills to practice a plant-based diet.
Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with five custom items developed by the research team, e.g., "I am confident that I can create a kitchen environment that makes it easier to store, prepare, and consume fruits, vegetables, whole grains, and beans."; the average of the five ratings was calculated to create a skills composite score (range 1-5; Cronbach's alpha=.88).
|
9 weeks
|
Skills to practice a plant-based diet
Time Frame: 15 weeks
|
Change from baseline in skills to practice a plant-based diet.
Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with five custom items developed by the research team, e.g., "I am confident that I can create a kitchen environment that makes it easier to store, prepare, and consume fruits, vegetables, whole grains, and beans."; the average of the five ratings was calculated to create a skills composite score (range 1-5; Cronbach's alpha=.88).
|
15 weeks
|
Barriers to eating more fruits and vegetables and whole grains
Time Frame: 9 weeks
|
Change from baseline in barriers to eating more fruits and vegetables and whole grains.
We adapted items from an existing barriers instrument to measure perceived barriers to eating more fruits and vegetables (F&V) (average score of 15 items; Cronbach's alpha = .89)
and whole grains (average score of 14 items; Cronbach's alpha = .83).
Participants were asked the general question, "Listed below are some common reasons why people don't eat more servings of vegetables and fruits each day.
Indicate whether or not this is a reason for you by marking how much you agree or disagree."
(1 = Strongly disagree; 5 = Strongly agree).
In addition, using the same list of possible reasons (excluding spoil too quickly), participants indicated whether it was a common reason they didn't eat more servings of whole grains.
Example reasons included: take too much time to prepare; my family doesn't like them; hard to find a variety of good ones.
|
9 weeks
|
Barriers to eating more fruits and vegetables and whole grains
Time Frame: 15 weeks
|
Change from baseline in barriers to eating more fruits and vegetables.
We adapted items from an existing barriers instrument to measure perceived barriers to eating more fruits and vegetables (F&V) (average score of 15 items; Cronbach's alpha = .89)
and whole grains (average score of 14 items; Cronbach's alpha = .83).
Participants were asked the general question, "Listed below are some common reasons why people don't eat more servings of vegetables and fruits each day.
Indicate whether or not this is a reason for you by marking how much you agree or disagree."
(1 = Strongly disagree; 5 = Strongly agree).
In addition, using the same list of possible reasons (excluding spoil too quickly), participants indicated whether it was a common reason they didn't eat more servings of whole grains.
Example reasons included: take too much time to prepare; my family doesn't like them; hard to find a variety of good ones.
|
15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Melissa Miller, PhD, American Institute for Cancer Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2019
Primary Completion (Actual)
August 12, 2019
Study Completion (Actual)
October 8, 2019
Study Registration Dates
First Submitted
August 17, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (Actual)
August 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 27, 2020
Last Update Submitted That Met QC Criteria
August 24, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 19048-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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