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Completed

NCT Number: NCT03134781

Hybrid Exercise Training for Weight Loss

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.

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Key information

Conditions

Circuit-based High Intensity Interval Training Body Composition Habitual Physical Activity Performance Resting Metabolic Rate

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Trikala, Karies, 42100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DoIT workout

Behavioral

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.

DoIT workout - Detraining

Behavioral

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.

Control - No training

Behavioral

No training was performed during a 40-week period. Participation only in measurements.

Primary outcomes

  1. Change in body mass

    Time frame: At baseline, at 20 weeks and at 40 weeks.

  2. Change in body mass index

    Time frame: At baseline, at 20 weeks and at 40 weeks.

  3. Change in waist circumference

    Time frame: At baseline, at 20 weeks and at 40 weeks.

  4. Change in hip circumference

    Time frame: At baseline, at 20 weeks and at 40 weeks.

  5. Change in waist-to-hip ratio

    Time frame: At baseline, at 20 weeks and at 40 weeks.

  6. 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).

  7. 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).

  8. 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).

  9. 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.

  10. Change in exercise-induced caloric expenditure.

    Time frame: At baseline, at 20 weeks and at 40 weeks.

    Measured using a portable indirect calorimetry system

Secondary outcomes

  1. Change in maximal strength (1RM)

    Time frame: At baseline, at 20 weeks and at 40 weeks.

    Measured bilaterally on a horizontal leg press.

  2. 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.

  3. Change in blood lactate concentration

    Time frame: Pre-exercise, during the exercise and post-exercise at baseline, at 20 weeks and at 40 weeks.

  4. 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

  5. Change in dietary intake

    Time frame: At baseline, at 20 weeks and at 40 weeks.

    Assessed using 7-day diet recalls

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Acronym: DoIT

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 1, 2017
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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