- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04961827
A Self-efficacy Based Dietary Intervention
Eat Well After Cancer: a Randomized Controlled Trial of a Self-efficacy Based Dietary Intervention Among Chinese Cancer Survivors
Study Overview
Status
Conditions
Detailed Description
Healthy eating is linked to improved survival and quality of life among cancer survivors. However, previous studies showed that most cancer survivors were not adhering to dietary recommendations despite having made changes post-diagnosis.
Conventional nutrition counseling interventions are often used in this population. However, they are labor and cost intensive and involved multiple sessions with participants. Written materials have often been used to facilitate improvements of dietary quality beyond nutrition counseling sessions but are outdated. Therefore, we propose to develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging. Methods to increase self-efficacy include performance accomplishment, persuasion, modelling and peer-modelling.
A prospective, randomized controlled trial design will be used to test the effectiveness of the intervention. A total of 168 adult Chinese cancer survivors, diagnosed with non-metastatic cancer (Stages 0-III), and have completed all active treatments, including surgery and adjuvant treatments such as chemotherapy and radiation therapy will be recruited.
Participants will be randomly assigned into one of two groups at a 1:1 ratio, using computer-generated block randomization sequences. The first group will be an active control group. Participants in this group will receive knowledge-based dietary information through an instant messaging applications biweekly for 6 times. The second group will be the intervention group. Participants will receive biweekly self-efficacy enhancing materials for 6 times. Materials will provide information about behavior-health link, provide information on consequences, provide instruction, and provide opportunities for social comparison. For example, the materials will provide recipe ideas and meal planning samples from fellow cancer survivors. All materials will be developed by a registered dietitian and will be consistent with published dietary guidelines for cancer survivors.
Participants will have follow-up appointments at 3 months. Their dietary quality and skin carotenoid status will be monitored. It is hypothesized that dietary quality will be better and skin carotenoid status will be higher for participants in the intervention group compared to participants in the active control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong
- JCICC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 or above
- Diagnosed with cancer, non-metastatic (Stages 0-III)
- Ability to read Chinese and speak Cantonese or Putonghua/Mandarin
- Completed all active treatments, including surgery and adjuvant treatments such as chemotherapy and radiation therapy
- Attending clinic with nutrition counseling at study site
Exclusion Criteria:
- Ethnicity other than Chinese
- Diagnosed with mental, hearing, speech, or cognitive disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention: Self-efficacy based images
Intervention group with self-efficacy based images sent through instant messaging biweekly for 6 times.
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A total of 6 images will be sent to participants via instant messaging.
Images will utilize concepts in the Theory of self-efficacy to increase dietary self-efficacy among participants and hence improve dietary quality beyond that of conventional nutrition counseling.
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|
Active Comparator: Active control: knowledge based images
Active control group with knowledge based images sent through instant messaging biweekly for 6 times.
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A total of 6 images will be sent to participants via instant messaging.
Images will consist of information covered in nutrition counseling sessions, such as those related to serving sizes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in mean dietary quality
Time Frame: Baseline and 3 months
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Servings of fruit and vegetables per day, number of red meat servings per week and ratio of whole to refined grains measured by a 3-day dietary record self-completed by participants before baseline and 3-months follow-up
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Baseline and 3 months
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Changes from baseline in mean skin carotenoid reading
Time Frame: Baseline and 3 months
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Skin carotenoid status reading measured by a reflective spectroscopy machine
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Baseline and 3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in mean self-efficacy score
Time Frame: Baseline and 3 months
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Dietary related self-efficacy measured by a 15-item scale (DIET-SE), consisted of 10 scenario based questions and 5 general questions.
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Baseline and 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wendy Lam, School of Public Health, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UW20-622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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