CancerNCT04961827
A Self-efficacy Based Dietary Intervention
A study testing Self-efficacy based images through instant messaging and Knowledge based images through instant messaging in people with Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
To develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Self-efficacy based images through instant messaging and Knowledge based images through instant messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Jul 2021to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ethnicity other than Chinese
- Diagnosed with mental, hearing, speech, or cognitive disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eat Well After Cancer: a Randomized Controlled Trial of a Self-efficacy Based Dietary Intervention Among Chinese Cancer Survivors
To develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging.
Read the 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.
- Conditions
- Cancer
- Being tested
- Self-efficacy based images through instant messaging, Knowledge based images through instant messaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-efficacy based images through instant messagingBehavioural
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.
Knowledge based images through instant messagingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Self-efficacy based images | Experimental | Intervention group with self-efficacy based images sent through instant messaging biweekly for 6 times. Receives: Behavioral: Self-efficacy based images through instant messaging |
| Active control: knowledge based images | Active comparator | Active control group with knowledge based images sent through instant messaging biweekly for 6 times. Receives: Behavioral: Knowledge based images through instant messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in mean dietary quality
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
Measured: Baseline and 3 months
Changes from baseline in mean skin carotenoid reading
Skin carotenoid status reading measured by a reflective spectroscopy machine
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start29 Jul 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Why it stopped: Due to a lack of manpower
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Wing Tak Lam, The University of Hong Kong
- Investigators
- Wendy Lam, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961827
- Sponsor's protocol ID
- UW20-622
- Status last verified
- May 2024
- First submitted
- 9 Jul 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eat Well After Cancer: a Randomized Controlled Trial of a Self-efficacy Based Dietary Intervention Among Chinese Cancer Survivors
- ClinicalTrials.gov ID
- NCT04961827
- Acronym / sponsor ID
- UW20-622
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a lack of manpower
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Self-efficacy based images | Experimental | Behavioral: Self-efficacy based images through instant messagingIntervention group with self-efficacy based images sent through instant messaging biweekly for 6 times. |
| Active control: knowledge based images | Active comparator | Behavioral: Knowledge based images through instant messagingActive control group with knowledge based images sent through instant messaging biweekly for 6 times. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Ethnicity other than Chinese
- Diagnosed with mental, hearing, speech, or cognitive disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-efficacy based images through instant messagingA 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. | Behavioural | Intervention: Self-efficacy based images |
| Knowledge based images through instant messagingA 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. | Behavioural | Active control: knowledge based images |
Primary outcome
Changes from baseline in mean dietary quality
Time frame: Baseline and 3 months
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
Changes from baseline in mean skin carotenoid reading
Time frame: Baseline and 3 months
Skin carotenoid status reading measured by a reflective spectroscopy machine
Results and safety
The study was stopped early (reason given: Due to a lack of manpower). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Lam principal investigator
School of Public Health, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-efficacy based images through instant messaging and Knowledge based images through instant messaging in people with Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to a lack of manpower). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in mean dietary quality (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.