PilatesNCT04880525
The Effect of a Weight-Loss Diet in Women Doing Reformer Pilates: A 12-Week Evaluation
A study testing Dietary intervention in people with Pilates and Diet, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine the effect of a weight-loss diet on body composition in women who practice reformer pilates for 12 weeks. It compares dietary habits and macro and micronutrient intakes in subjects with and without a weight-loss diet at the start and end of the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Mar 2020
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agree to participate in the study
- Being in the age range of 18-65
- Female
- Not a regular Pilates practitioner, and physically independent to perform basic daily activities
Who cannot join
- Refuse to participate in the study
- Being younger than 18 or over 65
- Male
- A regular Pilates practitioner
- Not being suitable for physical activity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University
Izmir, Cigli, 35620
About this study
The purpose of this study is to determine the effect of a weight-loss diet on body composition in women who practice reformer pilates for 12 weeks. It compares dietary habits and macro and micronutrient intakes in subjects with and without a weight-loss diet at the start and end of the study.
Read the detailed description
The effect of a weight-loss diet on body composition in women reformer pilates for 12 weeks was compared in this study. It compares dietary habits and macro and micronutrient intakes in subjects with and without a weight-loss diet at the start and end of the study.
A total of 49 women (18 years old) were randomly assigned to one of two groups: control (CG: reformer pilates; n=23) or study (SG: reformer pilates + weight-loss diet; n=26). Subjects in both groups did pilates for 45 minutes three times a week for a total of 12 weeks. At the start and end of the study, their body weight (kg), waist circumference (cm), hip circumference (cm), neck circumference (cm), mid-upper arm circumference (cm), and body composition [body fat (% ), body water (% ), body muscle (% )] were all measured. Their waist/height ratio and body mass index (kg/m2) were also measured at the start and end of the study. All subjects' dietary habits were questioned, their 24-hour retrospective food consumption was recorded, and their physical activity levels were assessed using the International Physical Activity Questionnaire (Short Form).
- Being tested
- Dietary intervention
- Keywords
- Pilates-based exercises, Weight Loss, Diet, Women, Body composition
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
In accordance with Turkey Dietary Guidelines, these diet plans were designed to provide 45-60% of energy from carbohydrates, 10-20% from protein, and 20-35 percent from fat.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The study group does reformer pilates for 45 minutes 3 days a week. The intensity of the workouts was gradually increased. Warm-up (10 minutes), main Pilates training activity (25 minutes), and cool-down (10 minutes) were the three parts of each session (10 minutes). In addition to pilates, the women in the SG followed a personalized weight loss diet. In accordance with Turkey Dietary Guidelines, these diet plans were designed to provide 45-60% of energy from carbohydrates, 10-20% from protein, and 20-35 percent from fat. Receives: Other: Dietary intervention |
| Control Group | No intervention | The control group does reformer pilates for 45 minutes 3 days a week. The intensity of the workouts was gradually increased. Warm-up (10 minutes), main Pilates training activity (25 minutes), and cool-down (10 minutes) were the three parts of each session (10 minutes). Individuals in the CG received no dietary or nutritional intervention. On any diet, the status of women in the CG was frequently questioned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anthropometric measurements
At the start and end of the study, their body weight (kg), waist circumference (cm), hip circumference (cm), neck circumference (cm) and mid-upper arm circumference (cm) were all measured. These measurements are expected to change according to the beginning of the study.
Measured: 12 weeks
Change in body composition
At the start and end of the study, their body fat (%), body water (%), body muscle (%) were all measured. Their waist-to-height ratio and body mass index (kg/m2) were also measured at the beginning and end of the study. These measurements are expected to change according to the beginning of the study.
Measured: 12 weeks
Food consumption
Their 24-hour retrospective food consumption were taken
Measured: 12 weeks
Physical activity levels
Their physical activity levels were evaluated through the International Physical Activity Questionnaire (IPAQ Short Form). This form had seven questions and asked about the amount of time spent sitting, walking, moderate, and vigorous activities. The total score accounted for the duration (minutes) and frequency (days) of the activities completed. Physical inactivity (600 MET -min/week), low physical activity (600-3000 MET -min/week), and adequate physical activity (with health benefits) (>3000 MET -min/week) were defined.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Sep 2019
- Primary completion31 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PilatesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For a period of 12 weeks, subjects in the Study Group (SG) and Control Group (CG) groups received three 45-minute sessions of Pilates exercises per week. Study Group: In addition to Pilates, she followed a three-month weight-loss diet based on Turkey Dietary Guidelines, as prescribed by the dietician. These diet plans were designed to ensure that carbohydrates provided 45-60% of the energy, protein provided 10-20%, and fat provided 20-35 percent. Control Group: The women in the control group did only reformer pilates for three months. They were followed up for not applying any diet.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla AYER, Izmir Katip Celebi University
- Investigators
- Çağla Ayer, M.D., Principal investigator, Izmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880525
- Sponsor's protocol ID
- 2020-629
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study's data is planned to be published and shared in a scientific paper
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Weight-Loss Diet in Women Doing Reformer Pilates: A 12-Week Evaluation
- ClinicalTrials.gov ID
- NCT04880525
- Acronym / sponsor ID
- 2020-629
- Keywords
- Pilates-based exercises, Weight Loss, Diet, Women, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 10 May 2021 (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.
The purpose of this study is to determine the effect of a weight-loss diet on body composition in women who practice reformer pilates for 12 weeks. It compares dietary habits and macro and micronutrient intakes in subjects with and without a weight-loss diet at the start and end of the study.
Detailed description
The effect of a weight-loss diet on body composition in women reformer pilates for 12 weeks was compared in this study. It compares dietary habits and macro and micronutrient intakes in subjects with and without a weight-loss diet at the start and end of the study.
A total of 49 women (18 years old) were randomly assigned to one of two groups: control (CG: reformer pilates; n=23) or study (SG: reformer pilates + weight-loss diet; n=26). Subjects in both groups did pilates for 45 minutes three times a week for a total of 12 weeks. At the start and end of the study, their body weight (kg), waist circumference (cm), hip circumference (cm), neck circumference (cm), mid-upper arm circumference (cm), and body composition [body fat (% ), body water (% ), body muscle (% )] were all measured. Their waist/height ratio and body mass index (kg/m2) were also measured at the start and end of the study. All subjects' dietary habits were questioned, their 24-hour retrospective food consumption was recorded, and their physical activity levels were assessed using the International Physical Activity Questionnaire (Short Form).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For a period of 12 weeks, subjects in the Study Group (SG) and Control Group (CG) groups received three 45-minute sessions of Pilates exercises per week. Study Group: In addition to Pilates, she followed a three-month weight-loss diet based on Turkey Dietary Guidelines, as prescribed by the dietician. These diet plans were designed to ensure that carbohydrates provided 45-60% of the energy, protein provided 10-20%, and fat provided 20-35 percent. Control Group: The women in the control group did only reformer pilates for three months. They were followed up for not applying any diet.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Dietary interventionThe study group does reformer pilates for 45 minutes 3 days a week. The intensity of the workouts was gradually increased. Warm-up (10 minutes), main Pilates training activity (25 minutes), and cool-down (10 minutes) were the three parts of each session (10 minutes). In addition to pilates, the women in the SG followed a personalized weight loss diet. In accordance with Turkey Dietary Guidelines, these diet plans were designed to provide 45-60% of energy from carbohydrates, 10-20% from protein, and 20-35 percent from fat. |
| Control Group | No intervention | –The control group does reformer pilates for 45 minutes 3 days a week. The intensity of the workouts was gradually increased. Warm-up (10 minutes), main Pilates training activity (25 minutes), and cool-down (10 minutes) were the three parts of each session (10 minutes). Individuals in the CG received no dietary or nutritional intervention. On any diet, the status of women in the CG was frequently questioned. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agree to participate in the study
- Being in the age range of 18-65
- Female
- Not a regular Pilates practitioner, and physically independent to perform basic daily activities
Key exclusion criteria (5 listed)
- Refuse to participate in the study
- Being younger than 18 or over 65
- Male
- A regular Pilates practitioner
- Not being suitable for physical activity
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 |
|---|---|---|
| Dietary interventionIn accordance with Turkey Dietary Guidelines, these diet plans were designed to provide 45-60% of energy from carbohydrates, 10-20% from protein, and 20-35 percent from fat. | Other | Study Group |
Primary outcome
Change in anthropometric measurements
Time frame: 12 weeks
At the start and end of the study, their body weight (kg), waist circumference (cm), hip circumference (cm), neck circumference (cm) and mid-upper arm circumference (cm) were all measured. These measurements are expected to change according to the beginning of the study.
Change in body composition
Time frame: 12 weeks
At the start and end of the study, their body fat (%), body water (%), body muscle (%) were all measured. Their waist-to-height ratio and body mass index (kg/m2) were also measured at the beginning and end of the study. These measurements are expected to change according to the beginning of the study.
Food consumption
Time frame: 12 weeks
Their 24-hour retrospective food consumption were taken
Physical activity levels
Time frame: 12 weeks
Their physical activity levels were evaluated through the International Physical Activity Questionnaire (IPAQ Short Form). This form had seven questions and asked about the amount of time spent sitting, walking, moderate, and vigorous activities. The total score accounted for the duration (minutes) and frequency (days) of the activities completed. Physical inactivity (600 MET -min/week), low physical activity (600-3000 MET -min/week), and adequate physical activity (with health benefits) (>3000 MET -min/week) were defined.
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 12 May 2021.
- Individual participant dataSharing planned: No. The study's data is planned to be published and shared in a scientific paper
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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.
Çağla Ayer, M.D. principal investigator
Izmir Katip Çelebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Pilates and Diet, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 12 May 2021. 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 Turkey (Türkiye). 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?
Change in anthropometric measurements (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2021.