Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04833595 |
| Other study ID # |
27779 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 29, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Monash University Malaysia |
| Contact |
Phaik Eong Poh, PhD |
| Phone |
+603 5514 6272 |
| Email |
poh.phaik.eong[@]monash.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
