Home Based or Traditional Class HIIT in Overweight Women.

March 12, 2021 updated by: João Luis Fernandes do Carmo, University of Évora

Home Based or Traditional Class HIIT in Overweight Women: Effects on Physical Activity, Body Composition and Cardio Respiratory Fitness. A 3-arm Randomized Control Trial.

The present protocol aims to evaluate the effect of two different 16-week High-intensity interval training (HIIT) programs on daily physical activity, body composition, cardiorespiratory fitness, eating behaviour, enjoyment and quality of life in overweight women. Methods: Ninety overweight women (25 - 50 years old) with a body mass index ≥ 25 kg/m2 will be randomly assigned to three groups of 30 participants: a remote home-based HIIT intervention group; a traditional HIIT intervention group; and a non-exercise control group. Both intervention groups will undergo a 16-week progressive HIIT program following the Tabata method. Participants will be assessed at baseline, 4th, 8th, and after 16-week for physical activity, body composition, cardiorespiratory fitness, eating behaviour, enjoyment and quality of life. The study will have a 16-week follow-up post intervention. Results: The participant's enrolment will begin in December 2021, and investigators will anticipate the study completion by the mid of 2022. Conclusions: The HIIT programs might have beneficial effects on daily physical activity, body composition, cardiorespiratory fitness and overall quality of life in overweight women. Moreover, it might be a more enjoyable form of exercise, once it is performed faster than other exercise forms. As a beneficial side effect, these healthy behaviours might have a favourable impact on women's eating behaviours. This study results are expected to add health and well-being professionals' evidence-based knowledge to create strategies and design home-based exercise interventions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Methods Trial design: The study will be a 3-arm Randomized Controlled Trial, in which a similar number of participants will be assigned to three groups: a supervised remote home-based HIIT intervention group (Home-HITT), or a presential a supervised traditional HIIT intervention group (Traditional-HIIT), and a non-exercise control group (CG). The study will have a 32-week duration and will be carried out in Portugal. This RCT will be "single-blind".

This study has been designed according to CONSORT statement for clinical trials. This RCT will apply the "intention-to-treat principle".

Dose rationale: The CG participants will maintain their usual physical and dietary activity. Nevertheless, after the 16-week intervention, participants selected to the CG will have the chance to receive the same 16-week HIIT program. Both interventions will consist of a 16-week exercise program with HIIT with a frequency of 3 days/week. The Home-HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application, while the Traditional-HIIT group participants will attend HIIT workout sessions supervised in person by the same instructor. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT training and 5 minutes' cool-down. The intervention will have a type of HIIT program called the Tabata method once it can be performed in home-based programs. Tabata training method has been defined as a HIIT with submaximal effort performed at 80-95% of maximal heart rate.

Tabata method uses eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. It seems that this method is demanding for ordinary adults so it will have four stages of physical adaptation.

Before each session, all participants in the intervention groups will receive a class reminder through a short message service (SMS). After each session, all participants will also receive an SMS with positive reinforcement about their exercise session participation. In order to compensate for possible absences, extra classes will be given. The 16 weeks intervention period was chosen because evidence shows that this period is sufficient to evidence changes in PA levels. Guidelines suggest the need to accumulate 75 min/week of vigorous-intensity PA. Despite the guidelines, this exercise protocol will be characterized by progression in both exercise intensity and volume because the investigators will be handling sedentary and overweight women.

The present study will have a follow-up period of 16 weeks. During this period, it is necessary to verify the study variables' evolution.

Selection and Withdrawal of Subjects: Participants in this study will be volunteers recruited through Health Centers Portimão, Lagoa and Lagos (Algarve, Portugal) and through promotional flyers placed in region´s local councils. All the participants will be informed of the procedures of the study before signing the informed consent form.

Subject Withdrawal: Individuals will be removed from the study when the following situations are verified: i) medical indication; ii) prolonged illness during the study or injury incapacitating to continue the study; iii) show willingness to leave the study. Participants may be replaced if the withdrawal happens before the intervention starts.

Discontinuation: The study should be interrupted if it is found that the application of the HIIT exercise program is at the origin of the participants physical and/or psychological problems. There will also be an interruption of the study if it is found that the participant initiated a physical exercise program parallel to the study.

Sample size Determination: To determine a priori the sample size, investigators used G*Power (version 3.1.9.7). The sample size was determined by the study's primary objective (effect of the intervention on PA, body composition and cardiovascular health). Based on a large effect size of 0.80 (Cohen's f), performing a sample size calculation for repeated measures analysis of variance with an expectable correlation of 0.50 between measurements, alfa of 0.05 and 85% of power, a total sample size of 60 women will be needed.

Once the investigators have two experimental groups, the aim is to have 90 women in this study.

Statistical Analysis SPSS (StatisticalPackage for the SocialSciences) software, version 27.0, IBM Windows will be used.

Regarding the procedures for sample distribution characterization's, the mean, standard deviation and amplitude of the distribution (min. value and max. value) will be determined. To determine data normality, the investigators will use the Kolmogorov-Smirnov analysis. Parametric statistics will be applied if data is normally distributed. One-way ANOVA will be used for comparisons of the three groups on all outcome's variables. To determine the relation between the independent measures, the investigators will use a two-way ANOVA. If there are significant differences between the different groups, the Bonferroni Post-hoc test will determine significance levels. In this study, the investigators will use a p-value of 0.05.

Randomization: In order to minimize selection bias, stratified randomization will be carried out when allocating individuals to the experimental and control groups, thus maintaining identical characteristics in both groups This stratification will be carried out based on age, sex and ethnicity.

Instruments: For the present study, participants will be evaluated before the intervention in the 4th ,8th and 16th week of the intervention. After that, participants will be evaluated in the 32nd week for follow-up to analyse the possible effect of detraining. Assessments will be performed through the following instruments:

  1. Sociodemographic questionnaire - Questionnaire made for the study with questions about age, sex;
  2. Anthropometry and Body Composition - Stature and weight will be evaluated to calculate body mass index. Weight and statures will be measured to the nearest 0.1Kg and 0.1cm correspondingly (calibrated weighing-machine and stadiometer). For the body mass index calculation, weight in kilo-grams will be divided by the height in squared meters. The criteria for defining excess weight and obesity proposed by World Health Organization. The waist circumference will be recorded using a non-elastic measuring tape, which is placed horizontally above the top of the iliac crest. This measurement should be performed with a tense tape without compressing the skin and at the end of exhalation. It will be assessed % fat mass, bone mass and muscle mass with a bioimpedance weighing-machine electric model Tanita BC601. Before the test, the participants will be told to lie down in a supination position to ensure good blood circulation;
  3. Blood Pressure (BP) - The BP will be assessed using electronic BP device OMRON M2 (13) according to validation protocols;
  4. PA Questionnaire - For measuring PA, by questionnaire it will be used International Physical Activity Questionnaire - Long Version (IPAQ);
  5. Daily PA - Objectively measured daily PA will be assessed through accelerometers, using the Model ActiGraph GT3X+ (Pensacola, USA), triaxial accelerometer, supported by the ActiLife Software. ActiGraf models have been widely used in research, and it is estimated that more than 50% of the research using accelerometry uses this brand. Participants will use the accelerometer for seven consecutive days, during the day and night (night sleep), except for activity involving water (e.g., swimming) or contact (e.g., combat sports). The devices will be placed in the hip because it seems to be more effective in classifying the intensity of PA and the movement patterns. The accelerometer will be programmed for 60 seconds epoch length. Each day will only be considered when recording at least 600 minutes of activity, i.e., 10 hours. The daily time spent in light, moderate and vigorous-intensity activities will be calculated;
  6. Exercise intensity - Investigators will monitor exercise intensity with the perceived exertion Borg Scale. This scale has been used in RCT with HIIT;
  7. Cardiorespiratory Fitness (CRF) - To assess VO2max the Chester Step Test will be used. This field test proved to be reliability to estimate CRF and has been used in controlled trials with the overweight population;
  8. Enjoyment - To measure the enjoyment, the investigators will use Portuguese version of the the Physical Activity Enjoyment Scale (PACES);
  9. Quality of life - To assess the quality of life it will be used the Portuguese version of the SF-36 Questionnaire. This questionnaire evaluates 8 dimensions: physical function, physical performance, physical pain, general health, mental health, emotional performance, social function and vitality;
  10. Eating Behaviour - The eating behaviour will be assessed through the Portuguese version of the Three-Factor Eating Questionnaire - R21 (TFEQ - R21) questionnaire, consisting of 21 items and three subscales: cognitive restraint, uncontrolled eating and emotional eating;
  11. Satisfaction with the study - A satisfaction Likert-scale questionnaire that the participants should fill out, aims to assess the satisfaction with the exercise classes. The Likert-scale questionnaire will be created for this purpose.

Timing: According to the inclusion/exclusion criteria mentioned, the participants will be assessed to be eligible to participate in the study. In December 2021, participants will be randomized and allocated in three different groups (CG, Home HIIT and Class HIIT). The intervention will begin in December 2021 and end in September 2022. The close-out of the study will be in September.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • 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 Contact

Study Contact Backup

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

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female individuals aged between 25 and 50 years old, at the time of selection;
  • have a BMI equal to or greater than 25kg/m2;
  • have the ZOOM application (San Jose, USA) and a 2x2m2 space at home for the practice of HIIT;
  • who present, in their own form, authorized consent to participate in the referred study. Only one person per household will be allowed to be included.

Exclusion Criteria:

  • having any health problem and/or condition that limit the implementation of an HIIT program;
  • taking medication that influences the variables to be studied;
  • being involved in any type of exercise intervention/program;
  • being in pre-menopause or menopause period.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention. The control group will maintain their normal physical and dietary activity.
Experimental: Homebased HIIT
16-week exercise program with HIIT with a frequency of 3 days/week. The Homebased HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application. This group will have 16 week follow-up.
Other: Home based HIIT

Intervention will consist in a 16-week exercise program with HIIT with a frequency of 3 days/week. The Home-HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT (stages of physical adaptation every 4 weeks) training and 5 minutes' cool-down. Tabata method will be used with eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. The intervention will have four stages of physical adaptation.

This group will have a follow-up period of 16 weeks.
Experimental: Traditional HIIT
16-week exercise program with HIIT with a frequency of 3 days/week. The Traditional-HIIT group participants will attend presential HIIT workout sessions supervised. This group will have 16 week follow-up.
Other: Traditional HIIT

Intervention will consist in a 16-week exercise program with HIIT with a frequency of 3 days/week. The Traditional HIIT group participants will attend a group HIIT workout sessions supervised by a specialised instructor in a sport facility. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT (stages of physical adaptation every 4 weeks) training and 5 minutes' cool-down. Tabata method will be used with eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. The intervention will have four stages of physical adaptation.

This group will have a follow-up period of 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline, between and within groups comparison, in Physical activity.
Time Frame: 0,4,8,16,32 weeks
Objectively measured daily physical activity will be assessed through accelerometers.
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in Cardiorespiratory fitness.
Time Frame: 0,4,8,16,32 weeks
To assess VO2max the Chester Step Test will be used.
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in percentage of fat mass.
Time Frame: 0,4,8,16,32 weeks
It will be assessed % fat mass with a bioimpedance weighing machine electric model Tanita BC601.
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in bone mass.
Time Frame: 0,4,8,16,32 weeks
It will be assessed bone mass with a bioimpedance weighing machine electric model Tanita BC601. The bone mass will be reported in kilograms.
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in muscle mass.
Time Frame: 0,4,8,16,32 weeks
It will be assessed muscle mass with a bioimpedance weighing machine electric model Tanita BC601. The muscle mass will be reported in kilograms.
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in body mass index (BMI).
Time Frame: 0,4,8,16,32 weeks
Weight and height will be measured to the nearest 0.1kg and 0.1cm correspondingly. For BMI, weight in kilograms will be divided by height in squared meters (kg/m2).
0,4,8,16,32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline, between and within groups comparison, in Quality of Life
Time Frame: 0,4,8,16,32 weeks
To assess the quality of life it will be used the Portuguese version of the SF-36 Questionnaire
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in Eating Behaviour
Time Frame: 0,4,8,16,32 weeks
The eating behaviour will be assessed through the Portuguese version of the Three-Factor Eating Questionnaire - R21
0,4,8,16,32 weeks
Change from Baseline, between and within groups comparison, in Enjoyment
Time Frame: 0,4,8,16,32 weeks
To measure the enjoyment it will use Portuguese version of the the PACES scale. This is a 8-item scale. Each item has a 7-point Likert scale (1= unpleasurable; 7= pleasurable).
0,4,8,16,32 weeks

Collaborators and Investigators

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

Sponsor

University of Évora

Collaborators

Raimundo, Armando, PhD
Bravo, Jorge, PhD
Mota, Jorge, PhD, University of Porto

Investigators

  • Study Director: Jorge Mota, PhD, Universidade do Porto
  • Study Director: Armando Raimundo, PhD, Universidade de Évora

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 (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21016 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Yes. We will publish the protocol and study results.

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)

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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