Cholesterol; LipidosisNCT04833595
Can Mindful Eating Improve Cholesterol and Glucose Level
A study testing Mindfulness practice in people with Cholesterol; Lipidosis, run by Monash University Malaysia at 1 site in Malaysia.
Trial summary
This study aims to explore the effectiveness of mindful eating and its effect on cholesterol and glucose level. The participants will be required to get tested for their fasting total cholesterol and blood glucose level for two times. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholesterol; Lipidosis
- What is being tested?
- Mindfulness practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 29 Mar 2021to 31 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Total fasting cholesterol of at least 5.2mmol/L
Who cannot join
- Familial hypercholesterolaemia or Pregnant women.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Monash University Malaysia
Subang Jaya, Selangor, 47500
Siew Li Teoh, MPharm, PhD, (+603) 5515-9646, teoh.siew.li@monash.edu
About this study
Official title: Can Mindful Eating Improve Cholesterol and Glucose Level: A Tele-Health Pilot-Randomised Controlled Trial
This study aims to explore the effectiveness of mindful eating and its effect on cholesterol and glucose level. The participants will be required to get tested for their fasting total cholesterol and blood glucose level for two times. At the first visit, they will be required to complete the survey given and be tested for their fasting total cholesterol and blood glucose level. A recommendation on healthy food intake will be sent to participants. At the end of each week, participants will be required 1) to submit THREE photos of the meals that they are most satisfied with in terms of healthiness and 2) using the photos to answer a questionnaire about their diet. The photos and completed questionnaire must be submitted to the research investigator each week for a total of 8 weeks. After 8 weeks, participants will be required to get tested for their fasting total cholesterol and blood glucose level in the appointed pharmacy for the second time. It is estimated to require 15-30 minutes of their time weekly.
Read the detailed description
Consistently high cholesterol or/and glucose level pose harmful threat to the body that may cause lethal health conditions (e.g. stroke, cardiovascular diseases). In addition, 3.6 million Malaysians are suffering from diabetes, the highest rate of incidence in Asia and one of the highest in the world. There is crucial need to find ways to improve the situation. Tele-health interventions and mindful eating behaviours are proposed to be effective in improving the levels of cholesterol and glucose. To investigate and explore the intervention, a small-scale randomised controlled trial will be conducted by comparing the effectiveness of mindful eating and the effect on cholesterol and glucose level. Students will collect and analyse both quantitative and qualitative data.
A small-scale randomised controlled trial will be conducted to compare the effectiveness of mindful eating and the effect on lipid level. Subjects will be randomly assigned to intervention or control group. For intervention group, subjects will be required to snap picture of every meal that they consume. At the end of the day, they are required to actively recall and reflect on how healthy they consider their meals to be. The reflection will be submitted to the research team daily together with the taken pictures of meal. As for the control group, subjects will only snap and submit the picture of their meals but without active recall and reflection.
Subjects are required to return to the community pharmacy after two months to follow-up on their glucose and lipid levels post intervention.
- Conditions
- Cholesterol; Lipidosis
- Being tested
- Mindfulness practice
- Medical subject headings
- Lipidoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness practiceBehavioural
Mindfulness is hypothesised to include reflective practice. Therefore, reflective questions are asked in the questionnaire for intervention group but not for control group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Arm | Experimental | A recommendation on healthy food intake will be sent to participants. At the end of each week, participants will be required 1) to submit THREE photos of the meals that they are most satisfied with in terms of healthiness and 2) using the photos to answer a questionnaire about their diet. The photos and completed questionnaire must be submitted to the research investigator each week for a total of 8 weeks. After 8 weeks, participants will be required to get tested for your fasting total cholesterol and blood glucose level in the appointed pharmacy for the second time. It is estimated to require 15-30 minutes of their time weekly.
The questionnaire used for experimental group contains reflective questions as part of the mindfulness intervention. Receives: Behavioral: Mindfulness practice |
| Non-mindfulness Arm | Active comparator | Everything is similar to the experimental arm. However, the questionnaire used for control group does not contain reflective questions to serve as control group. Receives: Behavioral: Mindfulness practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting total cholesterol
Total cholesterol taken after at least 8 hours fasting
Measured: 8 weeks
Secondary outcomes (1)
Fasting glucose
Blood glucose taken after at least 8 hours fasting
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start29 Mar 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol; LipidosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teoh Siew Li, Monash University Malaysia
- Investigators
- Phaik Eong Poh, PhD, Study director, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833595
- Sponsor's protocol ID
- 27779
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data will be shared upon request to investigator.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Mindful Eating Improve Cholesterol and Glucose Level: A Tele-Health Pilot-Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04833595
- Acronym / sponsor ID
- 27779
- Conditions
- Cholesterol; Lipidosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Monash University MalaysiaUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Apr 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.
This study aims to explore the effectiveness of mindful eating and its effect on cholesterol and glucose level. The participants will be required to get tested for their fasting total cholesterol and blood glucose level for two times. At the first visit, they will be required to complete the survey given and be tested for their fasting total cholesterol and blood glucose level. A recommendation on healthy food intake will be sent to participants. At the end of each week, participants will be required 1) to submit THREE photos of the meals that they are most satisfied with in terms of healthiness and 2) using the photos to answer a questionnaire about their diet. The photos and completed questionnaire must be submitted to the research investigator each week for a total of 8 weeks. After 8 weeks, participants will be required to get tested for their fasting total cholesterol and blood glucose level in the appointed pharmacy for the second time. It is estimated to require 15-30 minutes of their time weekly.
Detailed description
Consistently high cholesterol or/and glucose level pose harmful threat to the body that may cause lethal health conditions (e.g. stroke, cardiovascular diseases). In addition, 3.6 million Malaysians are suffering from diabetes, the highest rate of incidence in Asia and one of the highest in the world. There is crucial need to find ways to improve the situation. Tele-health interventions and mindful eating behaviours are proposed to be effective in improving the levels of cholesterol and glucose. To investigate and explore the intervention, a small-scale randomised controlled trial will be conducted by comparing the effectiveness of mindful eating and the effect on cholesterol and glucose level. Students will collect and analyse both quantitative and qualitative data.
A small-scale randomised controlled trial will be conducted to compare the effectiveness of mindful eating and the effect on lipid level. Subjects will be randomly assigned to intervention or control group. For intervention group, subjects will be required to snap picture of every meal that they consume. At the end of the day, they are required to actively recall and reflect on how healthy they consider their meals to be. The reflection will be submitted to the research team daily together with the taken pictures of meal. As for the control group, subjects will only snap and submit the picture of their meals but without active recall and reflection.
Subjects are required to return to the community pharmacy after two months to follow-up on their glucose and lipid levels post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Arm | Experimental | Behavioral: Mindfulness practiceA recommendation on healthy food intake will be sent to participants. At the end of each week, participants will be required 1) to submit THREE photos of the meals that they are most satisfied with in terms of healthiness and 2) using the photos to answer a questionnaire about their diet. The photos and completed questionnaire must be submitted to the research investigator each week for a total of 8 weeks. After 8 weeks, participants will be required to get tested for your fasting total cholesterol and blood glucose level in the appointed pharmacy for the second time. It is estimated to require 15-30 minutes of their time weekly. The questionnaire used for experimental group contains reflective questions as part of the mindfulness intervention. |
| Non-mindfulness Arm | Active comparator | Behavioral: Mindfulness practiceEverything is similar to the experimental arm. However, the questionnaire used for control group does not contain reflective questions to serve as control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total fasting cholesterol of at least 5.2mmol/L
Key exclusion criteria (1 listed)
- Familial hypercholesterolaemia or Pregnant women.
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 |
|---|---|---|
| Mindfulness practiceMindfulness is hypothesised to include reflective practice. Therefore, reflective questions are asked in the questionnaire for intervention group but not for control group. | Behavioural | Mindfulness Arm, Non-mindfulness Arm |
Primary outcome
Fasting total cholesterol
Time frame: 8 weeks
Total cholesterol taken after at least 8 hours fasting
1 secondary outcome
Fasting glucose
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No. Only aggregated data will be shared upon request to investigator.
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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.
Phaik Eong Poh, PhD study director
Monash University Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness practice in people with Cholesterol; Lipidosis, run by Monash University Malaysia at 1 site in Malaysia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phaik Eong Poh, PhD (+603 5514 6272, poh.phaik.eong@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting total cholesterol (time frame: 8 weeks). 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 8 Apr 2021.