NCT04833595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 2, 2021

Last Update Submit

April 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fasting total cholesterol

    Total cholesterol taken after at least 8 hours fasting

    8 weeks

Secondary Outcomes (1)

  • Fasting glucose

    8 weeks

Study Arms (2)

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.

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.

Behavioral: Mindfulness practice

Interventions

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

Mindfulness ArmNon-mindfulness Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total fasting cholesterol of at least 5.2mmol/L

You may not qualify if:

  • Familial hypercholesterolaemia or Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University Malaysia

Subang Jaya, Selangor, 47500, Malaysia

RECRUITING

MeSH Terms

Conditions

Lipidoses

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Phaik Eong Poh, PhD

    Monash University Malaysia

    STUDY DIRECTOR

Central Study Contacts

Phaik Eong Poh, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 6, 2021

Study Start

March 29, 2021

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Only aggregated data will be shared upon request to investigator.

Locations