- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04880525
The Effect of a Weight-Loss Diet in Women Doing Reformer Pilates: A 12-Week Evaluation
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cigli
-
Izmir, Cigli, Turkey, 35620
- Izmir Katip Celebi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refuse to participate in the study
- Being younger than 18 or over 65
- Male
- A regular Pilates practitioner
- Not being suitable for physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
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.
|
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.
|
|
No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
|
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.
|
12 weeks
|
|
Food consumption
Time Frame: 12 weeks
|
Their 24-hour retrospective food consumption were taken
|
12 weeks
|
|
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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Çağla Ayer, M.D., Izmir Katip Celebi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diet
-
University of ReadingCompletedDiet Modification | Diet, Healthy | Diet HabitUnited Kingdom
-
University of Rhode IslandCompletedDiet Modification | Diet HabitUnited States
-
National Cancer Institute (NCI)CompletedDiet | Diet SurveysUnited States
-
University of LeedsBritish Medical Research CouncilCompletedDiet Surveys | Diet RecordsUnited Kingdom
-
Washington State UniversityUnited States Department of Agriculture (USDA)CompletedHealth Behavior | Diet, Healthy | Diet HabitUnited States
-
Universidade do PortoCentro Hospitalar Universitário de São João, E.P.E.; Centro de Investigação... and other collaboratorsRecruitingNutritional Status | Diet, Vegetarian | Diet, Vegan | Metabolic ProfilePortugal
-
Instituto Nacional de Ciencias Medicas y Nutricion...Active, not recruitingDiet, Healthy | Diet Habit | Nutrition, Healthy | Dietary ExposureMexico
-
Luis María Béjar PradoRecruitingHealthy Eating Index | Mediterranean Diet | Diet HabitsSpain
-
San Raffaele Telematic UniversityCompletedPhysical Activity | Diet Therapy | Body Composition Changes | Mediterranean DietItaly
-
University of ReadingRoyal Berkshire NHS Foundation TrustCompletedDiet Modification | Diet Habit | Cardiac EventUnited Kingdom
Clinical Trials on Dietary intervention
-
University of ViennaCompletedEndotoxemia | Dietary HabitsAustria
-
Brown UniversityNational Cancer Institute (NCI)UnknownUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Brown UniversityNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Azienda Ospedaliero-Universitaria CareggiRecruiting
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
University Hospital, Strasbourg, FranceRecruitingDigestive Cancer | UndernourishedFrance
-
Josephine Ford Cancer CenterNational Cancer Institute (NCI)UnknownUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of South CarolinaAcademy of Nutrition and DieteticsCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Terminated