Can Mindful Eating Improve Cholesterol and Glucose Level

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.

Study Overview

• Status: Recruiting
• Conditions: Cholesterol; Lipidosis
• Intervention / Treatment: Behavioral: Mindfulness practice

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phaik Eong Poh, PhD; Phone Number: +603 5514 6272; Email: poh.phaik.eong@monash.edu

Study Locations

• Malaysia
  • Selangor
    • Subang Jaya, Selangor, Malaysia, 47500
      • Recruiting
      • Monash University Malaysia
      • Contact: Siew Li Teoh, MPharm, PhD; Phone Number: (+603) 5515-9646; Email: teoh.siew.li@monash.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Total fasting cholesterol of at least 5.2mmol/L

Exclusion Criteria:

• Familial hypercholesterolaemia or Pregnant women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting total cholesterol	Total cholesterol taken after at least 8 hours fasting	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Blood glucose taken after at least 8 hours fasting	8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Lipidoses
• Other Study ID Numbers: 27779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregated data will be shared upon request to investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No