NCT05034653

Brief Summary

This study was a quasi-experimental study established to determine the cardio-metabolic, anthropometric, dietary intake and quality of life changes following combined Intermittent Fasting Healthy Plate and Healthy Plate interventions among overweight and obese civil servants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

August 23, 2021

Last Update Submit

September 2, 2021

Conditions

Intermittent FastingObesity

Keywords

Intermittent FastingObesityOverweightHealthy Plate

Outcome Measures

Primary Outcomes (32)

  • Body weight changes

    Body weight changes measured in kilogram

    Change from Baseline Body Weight at week 12

  • Body weight changes

    Body weight changes measured in kilogram

    Change from Baseline Body Weight at week 24

  • Body mass index (BMI) changes

    Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)

    Change from Baseline BMI at week 12

  • Body mass index (BMI) changes

    Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)

    Change from Baseline BMI at week 24

  • Waist-Hip Ratio (WHR) changes

    WHR changes measured in centimeters (waist and hip circumference in centimeters)

    Change from Baseline WHR at week 12

  • Waist-Hip Ratio (WHR) changes

    WHR changes measured in centimeters (waist and hip circumference in centimeters)

    Change from Baseline WHR at week 24

  • Body Fat Percentage changes

    Body Fat Percentage changes measured in percentage

    Change from Baseline Body Fat Percentage at week 12

  • Body Fat Percentage changes

    Body Fat Percentage changes measured in percentage

    Change from Baseline Body Fat Percentage at week 24

  • Body Fat Mass changes

    Body Fat Mass changes measured in kilograms

    Change from Baseline Body Fat Mass at week 12

  • Body Fat Mass changes

    Body Fat Mass changes measured in kilograms

    Change from Baseline Body Fat Mass at week 24

  • Fat Free Mass changes

    Fat Free Mass changes measured in kilograms

    Change from Baseline Body Fat Mass at week 12

  • Fat Free Mass changes

    Fat Free Mass changes measured in kilograms

    Change from Baseline Body Fat Mass at week 24

  • Systolic Blood Pressure changes

    Systolic Blood Pressure changes measured in mmHg

    Change from Baseline Systolic Blood Pressure at week 12

  • Systolic Blood Pressure changes

    Systolic Blood Pressure changes measured in mmHg

    Change from Baseline Systolic Blood Pressure at week 24

  • Diastolic Blood Pressure changes

    Diastolic Blood Pressure changes measured in mmHg

    Change from Baseline Diastolic Blood Pressure at week 12

  • Diastolic Blood Pressure changes

    Diastolic Blood Pressure changes measured in mmHg

    Change from Baseline Diastolic Blood Pressure at week 24

  • Fasting Blood Glucose changes

    Fasting Blood Glucose changes measured in mmol/L

    Change from Baseline Fasting Blood Glucose at week 12

  • Fasting Blood Glucose changes

    Fasting Blood Glucose changes measured in mmol/L

    Change from Baseline Fasting Blood Glucose at week 24

  • 2-hour Post Prandial Blood Glucose changes

    2-hour Post Prandial changes measured in mmol/L

    Change from Baseline 2-hour Post Prandial at week 12

  • 2-hour Post Prandial Blood Glucose changes

    2-hour Post Prandial changes measured in mmol/L

    Change from Baseline 2-hour Post Prandial at week 24

  • HbA1c changes

    HbA1c changes measured in percentage

    Change from Baseline HbA1c at week 12

  • HbA1c changes

    HbA1c changes measured in percentage

    Change from Baseline HbA1c at week 24

  • Fasting Total Cholesterol changes

    Fasting Total Cholesterol changes measured in mmol/L

    Change from Baseline Fasting Total Cholesterol at week 12

  • Fasting Total Cholesterol changes

    Fasting Total Cholesterol changes measured in mmol/L

    Change from Baseline Fasting Total Cholesterol at week 24

  • Fasting Triglyceride changes

    Fasting Triglyceride changes measured in mmol/L

    Change from Baseline Fasting Triglyceride at week 12

  • Fasting Triglyceride changes

    Fasting Triglyceride changes measured in mmol/L

    Change from Baseline Fasting Triglyceride at week 24

  • Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes

    Fasting HDL-C measured in mmol/L

    Change from Baseline Fasting HDL-C at week 12

  • Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes

    Fasting HDL-C measured in mmol/L

    Change from Baseline Fasting HDL-C at week 24

  • Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes

    Fasting LDL-C measured in mmol/L

    Change from Baseline Fasting LDL-C at week 12

  • Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes

    Fasting LDL-C measured in mmol/L

    Change from Baseline Fasting LDL-C at week 24

  • Fasting Insulin changes

    Fasting Insulin measured in uU/ml

    Change from Baseline Fasting Insulin at week 12

  • Fasting Insulin changes

    Fasting Insulin measured in uU/ml

    Change from Baseline Fasting Insulin at week 24

Secondary Outcomes (2)

  • Quality of Life changes

    At baseline, week 12 and week 24

  • Dietary Intake changes

    At baseline, week 12 and week 24

Study Arms (2)

Intermittent Fasting Healthy Plate (IFHP)

EXPERIMENTAL

Dry fasting from dawn to dusk for two days a week (Monday and Thursday) and Healthy Plate for the rest of the week. Female participants were discouraged from fasting during their menstruation period.

Other: Intermittent FastingOther: Healthy Plate

Healthy Plate

ACTIVE COMPARATOR

Practice the Healthy Plate concept in at least one meal every day

Other: Healthy Plate

Interventions

Intermittent FastingOTHER

During fasting day, no food or drink allowed from dawn to dusk

Also known as: Dry Intermittent Fasting
Intermittent Fasting Healthy Plate (IFHP)
Healthy PlateOTHER

Quarter-quarter-half meal concept

Also known as: Malaysian Healthy Plate
Healthy PlateIntermittent Fasting Healthy Plate (IFHP)

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 19-59 years
  • BMI of ≥ 23 kg/m2 (overweight or obese)
  • who is ready to participate in the intervention (was assessed through readiness to participate screening)
  • who can provide informed consent.

You may not qualify if:

  • has recent involvement in weight loss program/activity (intermittent fasting/diet changes/physical activity changes or any activities that are performed constantly to reduce weight)
  • suffering from any eating disorder
  • was diagnosed with diabetes and hypertension (on medication) or other metabolic health disturbances such as thyroid disease, chronic kidney disease, malignancy and polycystic ovarian syndrome (PCOS)
  • taking any medication or supplements that can affect study outcome
  • pregnant
  • has lack of capacity/language skills to independently follow the protocol were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Institute of Health

Shah Alam, Selangor, 40170, Malaysia

Location

Institut Latihan Kementerian Kesihatan Malaysia

Kuala Lumpur, 51000, Malaysia

Location

Institute for Medical Research

Kuala Lumpur, 51000, Malaysia

Location

Related Publications (1)

  • Abdullah SR, Azizul NH, Wan Mohd Zin RM, Sulaiman NS, Mustafa Khalid N, Mohd Salim Mullahi Jahn RJ, Khalil MKN, Abu Seman N, Zainal Abidin NA, Ali A, Tan YZ, Omar A, Johari MZ, Abdul Aziz NS, Baharudin A, Seman Z, Ibrahim Wong N, Md Rasip ML, Yusof HM, Md Noh MF. Cardiometabolic and Anthropometric Outcomes of Intermittent Fasting Among Civil Servants With Overweight and Obesity: Study Protocol for a Nonrandomized Controlled Trial. JMIR Res Protoc. 2022 Aug 5;11(8):e33801. doi: 10.2196/33801.

    PMID: 35930331DERIVED

MeSH Terms

Conditions

Intermittent FastingObesityOverweight

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study applying mixed study method that consists of two parts: quantitative and qualitative. The quantitative part involved allocating participants into two intervention arms; combined Intermittent Fasting and Healthy Plate (IFHP) group and Healthy Plate (HP) group, and measuring the outcomes at baseline, 3-month and 6-month. On the other hand, the qualitative part aimed to explore the facilitators and barriers that enable or admonish the success of weight loss in the IFHP group through Focused Group Discussion that was conducted at month 6.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 5, 2021

Study Start

June 1, 2020

Primary Completion

April 7, 2021

Study Completion

May 5, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

MY(3)