Can Mindful Eating Improve Cholesterol and Glucose Level

Sponsor
Monash University Malaysia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04833595
Collaborator
(none)
60
1
2
9.1
6.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness practice
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Can Mindful Eating Improve Cholesterol and Glucose Level: A Tele-Health Pilot-Randomised Controlled Trial
Actual Study Start Date :
Mar 29, 2021
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness Arm

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.

Behavioral: Mindfulness practice
Mindfulness is hypothesised to include reflective practice. Therefore, reflective questions are asked in the questionnaire for intervention group but not for control group.

Active Comparator: Non-mindfulness Arm

Everything is similar to the experimental arm. However, the questionnaire used for control group does not contain reflective questions to serve as control group.

Behavioral: Mindfulness practice
Mindfulness is hypothesised to include reflective practice. Therefore, reflective questions are asked in the questionnaire for intervention group but not for control group.

Outcome Measures

Primary Outcome Measures

  1. Fasting total cholesterol [8 weeks]

    Total cholesterol taken after at least 8 hours fasting

Secondary Outcome Measures

  1. Fasting glucose [8 weeks]

    Blood glucose taken after at least 8 hours fasting

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Total fasting cholesterol of at least 5.2mmol/L
Exclusion Criteria:
  • Familial hypercholesterolaemia or Pregnant women.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Monash University Malaysia Subang Jaya Selangor Malaysia 47500

Sponsors and Collaborators

  • Monash University Malaysia

Investigators

  • Study Director: Phaik Eong Poh, PhD, Monash University Malaysia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Teoh Siew Li, Lecturer, Monash University Malaysia
ClinicalTrials.gov Identifier:
NCT04833595
Other Study ID Numbers:
  • 27779
First Posted:
Apr 6, 2021
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2021