Hybrid Exercise Training for Weight Loss (DoIT)

October 25, 2021 updated by: Ioannis G. Fatouros, University of Thessaly

The Effects of a Novel Hybrid Exercise Training Program on Body Composition, Body Weight and Energy Balance in Sedentary Overweight/Obese Women

In this study the investigators utilized a novel hybrid HIIT (high intensity interval training) exercise training approach, the Hybrid Interval Training (DoIT) workout that combines interval training, resistance exercise training and functional training in order to test the hypothesis that DoIT will be able to: i) reduce body mass, ii) improve body composition and iii) alter energy balance, of previously inactive, overweight/obese women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In a controlled randomized, two-group, repeated measures design, 65 healthy, sedentary, premenopausal overweight or obese women were randomly assigned to one of three groups: (a) a control group (C, N=21) that participated only in measurements, (b) a training group (TR, N=14) that participated in a supervised 40-week DoIT workout exercise training program and (c) a training-detraining group (TRD, N=14). During the first 20 weeks, TR and TRD followed exactly the same training protocol. At the end of this period, TR continued training for 20 more weeks whereas TRD terminated training for 20 weeks (detraining). Anthropometric, metabolic, daily nutritional intake, habitual physical activity and performance measurements were performed in all groups at baseline, at 20 weeks and 40 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Karies
      • Trikala, Karies, Greece, 42100
        • Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • (a) were sedentary (<7,500 steps/day; VO2max <30 ml/kg/min), b) premenopausal women aged 30-45 years, c) were overweight or obese class 1 (BMI=25-34.9 kg/m2), d) were non-smokers for ≥6 months before the study, e) not following a diet intervention or using nutritional supplements/medications before (≥6 months) and during the study, f) had no weight loss greater >10% of body mass ≤6 months before the study, g) participated in ≥80% of total exercise sessions, and h) had no symptoms of depression.

Exclusion Criteria:

  • a) a recent febrile illness, b) history of muscle lesion, c) lower limb trauma, d) signs, symptoms or diagnosis of serious health complications or physical disability or other medical condition compromising safe participation in exercise training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control
Participated only in measurements at baseline, at 20 weeks and at 40 weeks.
Behavioral: Control - No training
No training was performed during a 40-week period. Participation only in measurements.
Experimental: Training
Participated in a supervised 40-week DoIT workout exercise training program and in measurements at baseline, at 20 weeks and at 40 weeks.
Behavioral: DoIT workout
A hybrid small-group (5-10 women/session) training modality, that combines interval training, resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management. FFIT was performed 3 times/week with 48 hours recovery between sessions for 40 weeks.
Experimental: Training-Detraining
Participated in a supervised 20-week DoIT workout exercise training program and then entered a 20-week detraining period. They also participated in measurements at baseline, at 20 weeks and at 40 weeks.
Behavioral: DoIT workout - Detraining
A hybrid small-group (5-10 women/session) training modality, that combines interval training, resistance exercise and functional training, performed according to a periodized model of exercise prescription for a 20-week period (3 times/week). Immediately after a 20-week detraining period (no training was performed) was followed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in body mass
Time Frame: At baseline, at 20 weeks and at 40 weeks.
At baseline, at 20 weeks and at 40 weeks.
Change in body mass index
Time Frame: At baseline, at 20 weeks and at 40 weeks.
At baseline, at 20 weeks and at 40 weeks.
Change in waist circumference
Time Frame: At baseline, at 20 weeks and at 40 weeks.
At baseline, at 20 weeks and at 40 weeks.
Change in hip circumference
Time Frame: At baseline, at 20 weeks and at 40 weeks.
At baseline, at 20 weeks and at 40 weeks.
Change in waist-to-hip ratio
Time Frame: At baseline, at 20 weeks and at 40 weeks.
At baseline, at 20 weeks and at 40 weeks.
Change in body fat.
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Body fat assessed by whole-body dual-energy X-ray absorptiometry (DXA).
At baseline, at 20 weeks and at 40 weeks.
Change in fat mass
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Fat mass assessed by whole-body dual-energy X-ray absorptiometry (DXA).
At baseline, at 20 weeks and at 40 weeks.
Change in fat-free mass
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Fat-free mass assessed by whole-body dual-energy X-ray absorptiometry (DXA).
At baseline, at 20 weeks and at 40 weeks.
Change in resting metabolic rate
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Measured using a portable open-circuit indirect calorimeter with a ventilated hood system.
At baseline, at 20 weeks and at 40 weeks.
Change in exercise-induced caloric expenditure.
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Measured using a portable indirect calorimetry system
At baseline, at 20 weeks and at 40 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in maximal strength (1RM)
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Measured bilaterally on a horizontal leg press.
At baseline, at 20 weeks and at 40 weeks.
Change in maximal oxygen consumption (VO2max)
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Assessed by a portable open-circuit spirometry system.
At baseline, at 20 weeks and at 40 weeks.
Change in blood lactate concentration
Time Frame: Pre-exercise, during the exercise and post-exercise at baseline, at 20 weeks and at 40 weeks.
Pre-exercise, during the exercise and post-exercise at baseline, at 20 weeks and at 40 weeks.
Change in habitual physical activity
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Seven-day habitual physical activity was assessed by accelerometry
At baseline, at 20 weeks and at 40 weeks.
Change in dietary intake
Time Frame: At baseline, at 20 weeks and at 40 weeks.
Assessed using 7-day diet recalls
At baseline, at 20 weeks and at 40 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DoIT-UTH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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