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OpenTrials
Completed

NCT Number: NCT07804329

Adherence and Quality of Life Across Three Different Intermittent Fasting Protocols in Obese Working Women

In these recent years, Intermittent Fasting (IF) has become popular among the public and health fraternities not only because it produced evidence-based results as an alternative dietary approach in weight loss strategy, but also putative for its practical implementation to link with daily routine. IF is defined as a range of dietary regimens involving fasting for an extended time period (16-48hrs) with little to no energy intake on fast day. However, there are many types of IF regiments with different methodological approaches, and results are inconsistent and debatable. Therefore, it has raised a question on which IF regimen design will possibly maximise the health benefit. Thus, the aim of this study is to identify IF regimens that are most feasible and acceptable to working women. The purpose of this study was to examine which type of IF regiment is more feasible for weight loss intervention programmes by prescribing three different types of IF to participants

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Key information

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports and Exercise Science

Kuala Lumpur, 50603, Malaysia

About this study

The order in which participants get the interventions was randomized. Body composition were measured before and after intervention by using inBody machine and a quality of life survey was conducted at the end of the intervention by using the Short Form (SF-12) Health Survey form. Adherence to the IF protocol were monitored througout the intervention period of 4 weeks. The procedure of 3 different types of IF regiment: Time restricted eating (TRE), Periodic Fasting 2days/week (PF5:2) and Modified Alternate Day Fasting (MADF). Participants were assigned to one of these three IF groups. Participation in this study was completely voluntary.

Benefit of Study: This study provided education on food selection during IF implementation, food intake monitoring/record strategy, and established support system that motivated participants to continue healthy dietary intake and make it a lifestyle.

Risk of study: Participation in this study was at minimal risk. However, participants were informed that if they ever feel uncomfortable during the study, they may decide to stop at any time and notify us through support group that was developed and accessible by all participants.

Confidentiality: All of the data collected were held confidential. In anything we write or present, participants name remained anonymous. All the data collected were stored in a device protected with password which is accessible by researchers only. Hardcopy documents with participants details, i.e name, address and other personal information were kept in a dedicated drawer located at nutrition lab at Faculty of Sport and Exercise Sciences and accessible to researchers only.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a body mass index (BMI) of 27.5-32.4 kg/m² (obesity class I), low physical activity levels (<150 minutes/week), and no prior participation in health or diet-related programs.

Exclusion criteria

  • Women who were pregnant, had cardiovascular disease or a history of eating disorders were excluded

Treatment and study plan

Adherence to the IF Protocol

Other

Adherence Percentage

Other names: Adherence Percentage

Quality of life

Other

Survey of PCS and MCS Score

Primary outcomes

  1. Adherence Percentage

    Time frame: Daly throughout 4 weeks of intervention. From Day 1 until Day 28

    Number of days adhered to daily energy requirement divided by total of intervention days. Adherence Percentage = (No. of days adhered to daily energy requirement/No. of intervention days)*100

Secondary outcomes

  1. Anthropometry and Body Composition

    Time frame: Pre and post-measurement. Measured at baseline (Day 1), and post-intervention (Day 28)

    Anthropometry and Body Composition as exploratory measures. Body weight was measured in kilograms (kg), and height was measured in centimetres and then converted to metres. Both body weight and height were used to measure body mass index (BMI) in kg/m². Fat mass, skeletal muscle mass and fat-free mass were measured in both percentage and kilograms by using InBody Machine.

Other outcomes

  1. Health-related Quality of Life (HQoL)

    Time frame: Measured at post-intervention only, at the end of 4 week of intervention, on day 28.

    The measurement was done through Short Form-12 (SF-12). It is a 12-question survey used to measure a person's Health-Related Quality of Life (HQoL). The survey result was devided into Physical Component Score (PCS) and Mental Component Score (MCS). The score for each component ranged from 0-100. The higher the score, the better the component measured.

Sponsors and collaborators

Lead sponsor

Suriana Md Akir

Other

Registry information

Official study title

Adherence and Quality of Life Across Three Different Intermittent Fasting Protocols in Obese Working Women: A Randomised Controlled Trial. This

Acronym: IF

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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