NCT04880525

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 5, 2021

Last Update Submit

May 8, 2021

Conditions

Keywords

Pilates-based exercisesWeight LossDietWomenBody composition

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    12 weeks

  • Food consumption

    Their 24-hour retrospective food consumption were taken

    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.

    12 weeks

Study Arms (2)

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.

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.

Interventions

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

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt became well-known in the twentieth century, particularly among women. Reformer pilates exercises are preferred by women for aesthetic reasons such as weight loss, slimming, staying in shape, muscle strengthening, muscle pain relief, and flexibility.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refuse to participate in the study
  • Being younger than 18 or over 65
  • Male
  • A regular Pilates practitioner
  • Not being suitable for physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmir, Cigli, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Çağla Ayer, M.D.

    Izmir Katip Çelebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There was no masking in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 10, 2021

Study Start

September 1, 2019

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

The study's data is planned to be published and shared in a scientific paper

Locations