Obese AdultsIFNCT07804329
Adherence and Quality of Life Across Three Different Intermittent Fasting Protocols in Obese Working Women
A study testing Adherence to the IF Protocol and Quality of Life in people with Obese Adults, run by Suriana Md Akir at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Obese Adults
- What is being tested?
- Adherence to the IF Protocol and Quality of Life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Women who were pregnant, had cardiovascular disease or a history of eating disorders were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence and Quality of Life Across Three Different Intermittent Fasting Protocols in Obese Working Women: A Randomised Controlled Trial. This
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
Read the detailed description
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.
- Conditions
- Obese Adults
- Being tested
- Adherence to the IF Protocol, Quality of Life
- Keywords
- Intermittent Fasting, Time Restricted Eating, Modified Alternate Day Fasting, Periodic Fasting, Adherence, Quality of Life
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence to the IF ProtocolOther
Also called Adherence Percentage
Adherence Percentage
Quality of LifeOther
Survey of PCS and MCS Score
| Study group | Role | What they receive |
|---|---|---|
| MADF | Experimental | Different types of intermittent fasting protocol Receives: Other: Adherence to the IF Protocol; Other: Quality of Life |
| TRE | Experimental | Type of IF Receives: Other: Adherence to the IF Protocol; Other: Quality of Life |
| PF5:2 | Experimental | Typr of IF Receives: Other: Adherence to the IF Protocol; Other: Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Percentage
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
Measured: Daly throughout 4 weeks of intervention. From Day 1 until Day 28
Secondary outcomes (1)
Anthropometry and Body Composition
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.
Measured: Pre and post-measurement. Measured at baseline (Day 1), and post-intervention (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Apr 2023
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obese AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomised control trials. participant is randomised sigle blinded to one of the intermittent fasting protocols (TRE, MADF or PF5:2)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suriana Md Akir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suriana Md Akir, University of Malaya
- Investigators
- Sareena Hanim Hamzah, Associate Proffesor, Principal investigator, Faculty of Sports and Exercise Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804329
- Sponsor's protocol ID
- UMREC_2245
- Other IDs
- FP010-2023
- Acronym
- IF
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study was conducted in Apr 2023
Publications
Varady KA, Cienfuegos S, Ezpeleta M, Gabel K. Clinical application of intermittent fasting for weight loss: progress and future directions. Nat Rev Endocrinol. 2022 May;18(5):309-321. doi: 10.1038/s41574-022-00638-x. Epub 2022 Feb 22.
PubMed 35194176Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717Antoni R, Johnston KL, Collins AL, Robertson MD. Intermittent v. continuous energy restriction: differential effects on postprandial glucose and lipid metabolism following matched weight loss in overweight/obese participants. Br J Nutr. 2018 Mar;119(5):507-516. doi: 10.1017/S0007114517003890.
PubMed 29508693Welton S, Minty R, O'Driscoll T, Willms H, Poirier D, Madden S, Kelly L. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020 Feb;66(2):117-125.
PubMed 32060194Zang BY, He LX, Xue L. Intermittent Fasting: Potential Bridge of Obesity and Diabetes to Health? Nutrients. 2022 Feb 25;14(5):981. doi: 10.3390/nu14050981.
PubMed 352679591. Lean MEJ. Management of obesity and overweight. Medicine (Baltimore). 2019;47(3):175-183. https://doi.org/10.1016/j.mpmed.2018.12.008
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and Quality of Life Across Three Different Intermittent Fasting Protocols in Obese Working Women: A Randomised Controlled Trial. This
- ClinicalTrials.gov ID
- NCT07804329
- Acronym / sponsor ID
- IF / UMREC_2245
- Conditions
- Obese Adults
- Keywords
- Intermittent Fasting, Time Restricted Eating, Modified Alternate Day Fasting, Periodic Fasting, Adherence, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Suriana Md AkirUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomised control trials. participant is randomised sigle blinded to one of the intermittent fasting protocols (TRE, MADF or PF5:2)
| Arm | Type | Receives |
|---|---|---|
| MADF | Experimental | Other: Adherence to the IF Protocol, Other: Quality of LifeDifferent types of intermittent fasting protocol |
| TRE | Experimental | Other: Adherence to the IF Protocol, Other: Quality of LifeType of IF |
| PF5:2 | Experimental | Other: Adherence to the IF Protocol, Other: Quality of LifeTypr of IF |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who were pregnant, had cardiovascular disease or a history of eating disorders were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence to the IF ProtocolAlso: Adherence PercentageAdherence Percentage | Other | MADF, PF5:2, TRE |
| Quality of LifeSurvey of PCS and MCS Score | Other | MADF, PF5:2, TRE |
Primary outcome
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
1 secondary outcome
Anthropometry and Body Composition
Time frame: Pre and post-measurement. Measured at baseline (Day 1), and post-intervention (Day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 35194176Varady KA, Cienfuegos S, Ezpeleta M, Gabel K. Clinical application of intermittent fasting for weight loss: progress and future directions. Nat Rev Endocrinol. 2022 May;18(5):309-321. doi: 10.1038/s41574-022-00638-x. Epub 2022 Feb 22.
- Background: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Background: PubMed 29508693Antoni R, Johnston KL, Collins AL, Robertson MD. Intermittent v. continuous energy restriction: differential effects on postprandial glucose and lipid metabolism following matched weight loss in overweight/obese participants. Br J Nutr. 2018 Mar;119(5):507-516. doi: 10.1017/S0007114517003890.
- Background: PubMed 32060194Welton S, Minty R, O'Driscoll T, Willms H, Poirier D, Madden S, Kelly L. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020 Feb;66(2):117-125.
- Background: PubMed 35267959Zang BY, He LX, Xue L. Intermittent Fasting: Potential Bridge of Obesity and Diabetes to Health? Nutrients. 2022 Feb 25;14(5):981. doi: 10.3390/nu14050981.
- Background1. Lean MEJ. Management of obesity and overweight. Medicine (Baltimore). 2019;47(3):175-183. https://doi.org/10.1016/j.mpmed.2018.12.008
- National Health and Morbidity Survey (NHMS) 2023Link provided by the sponsor.
- Individual participant dataSharing planned: No. This study was conducted in Apr 2023
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sareena Hanim Hamzah, Associate Proffesor principal investigator
Faculty of Sports and Exercise Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence to the IF Protocol and Quality of Life in people with Obese Adults, run by Suriana Md Akir at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Percentage (time frame: Daly throughout 4 weeks of intervention. From Day 1 until Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07804329, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.