Can Mindful Eating Improve Cholesterol and Glucose Level

NCT ID: NCT04833595

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2021-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness practice

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Mindfulness practice

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Total fasting cholesterol of at least 5.2mmol/L

Exclusion Criteria

• Familial hypercholesterolaemia or Pregnant women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Monash University Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Teoh Siew Li

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phaik Eong Poh, PhD

Role: STUDY_DIRECTOR

Monash University Malaysia

Locations

Monash University Malaysia

Subang Jaya, Selangor, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Phaik Eong Poh, PhD

Role: CONTACT

poh.phaik.eong@monash.edu

+603 5514 6272

Facility Contacts

Siew Li Teoh, MPharm, PhD

Role: primary

teoh.siew.li@monash.edu

(+603) 5515-9646

Other Identifiers

27779

Identifier Type: -

Identifier Source: org_study_id