Healthy VolunteersNCT03852043
High-intensity Interval Training on the Self-esteem, Basal Metabolic Rate and Muscle Mass in Overweight Women.
A study testing High-intensity interval training and Moderate-intensity continuous training in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Overweight and obesity are a public health problem for society, reflected by an increase in its prevalence worldwide, being more frequent in women and related to low levels of self-esteem, accumulation of subcutaneous fat and internal organs, reduction of muscle mass (MM) and basal metabolic rate (BMR). Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- High-intensity interval training and Moderate-intensity continuous training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteColombia
- Study dates
- 26 Feb 2018to 5 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 to 44 years old, overweighted (BMI ≥ 25 kg / m2) who agree to participate by signing the informed consent, no more than 600 Met / physical activity min / wk (be quantified with the Global Physical Activity Questionnaire - GPAQ), and have less than 30 points on the self-esteem scale.
Who cannot join
- History of uncontrolled noncommunicable diseases (hypothyroidism, diabetes, asthma and high blood pressure, cardiac arrhythmias), motor disorders or sensitive to hinder the exercise, consumption of anticoagulants, medication altering heart rate (beta-blockers, calcium antagonists, bronchodilators), steroid use, abuse of psychoactive substances, personal history of surgical procedures in the last three months, depressive disorders; pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a HIIT Program Compared to MICT on the Self-esteem, Basal Metabolic Rate and Muscle Mass in Women 18 to 44 Years Old With Overweight or Obesity, Over a Period of 8 Weeks: a Randomized Control Trial.
Overweight and obesity are a public health problem for society, reflected by an increase in its prevalence worldwide, being more frequent in women and related to low levels of self-esteem, accumulation of subcutaneous fat and internal organs, reduction of muscle mass (MM) and basal metabolic rate (BMR). Women are more predisposed to present weight gain because they are metabolically less efficient, have greater food intake, greater physical inactivity, and genetic factors. The different methods of physical training used for weight control are continuous training (CT) and the high-intensity interval training (HIIT). Both CT and HIIT have shown benefits without finding superiority of any of these methods. Nevertheless, there is a trend to the use HIIT programs, since they are more time-efficient and supports their use to induce physiological and metabolic adaptations over time, since this is a barrier to adherence to exercise programs. Overweight and obesity causes individual alterations in body composition and exercise leads to increase in MM, increase in caloric expenditure during the training session and increase in BMR due to the onset of muscle growth, secondary to an increase in the activity of the mitochondrial enzymes (greater mitochondrial biogenesis in the muscle), adaptations that could depend on the type of exercise, its intensity and the volume of it, but it is not clear due to the lack of evidence regarding this.
The primary objective of this study is to demonstrate that a HIIT program of short duration in a real-world setting has a standardized mean difference (SMD) higher than 0.84 in the improvement of self-esteem when comparing with a moderate-intensity continuous training (MICT) in women 18 to 44 years with overweight and obesity and low self-esteem, during eight weeks.
The secondary objective is to demonstrate that a low-volume HIIT in a real-world setting improves MM in 2% compared with MICT during a period of eight weeks in women 18 to 44 years.
Read the detailed description
Fifty women with low self-esteem will be randomly assigned to one of two training programs (MICT or HIIT) in a real-world setting. Both groups will perform three times a week for eight-weeks on alternate days.
The women in each group will perform three workouts per week for a period of eight weeks. The moderate-intensity continuous training group will perform a training session of 40 min duration at an intensity between 65 and 75% of your HRmax. Women assigned to the group HIIT will perform a training session of 22 minutes of duration by performing intervals of high intensity between 90 and 95 % of the HRmax for 30 seconds in duration and with a recovery of one minute training at moderate intensity is between 50 and 60 % of the HRmax, doing 15 loads of 30 seconds at high intensity, with 60 seconds of recovery between loads at moderate intensity. At the beginning of each training session, both groups will complete strength exercises mainly including large muscle groups (hip, knees, and ankles) with Theraband® (blue color ) for 3 sets of 15 repetitions.
All participants will be evaluated before initiating interventions and upon completion of the training program, after eight weeks, self-esteem will be assessed using the Rosenberg self-esteem scale, determination of anthropometric variables such as weight, height, waist circumference, arterial pressure, body composition by bioimpedance and the basal metabolic rate.
- Conditions
- Healthy Volunteers
- Being tested
- High-intensity interval training, Moderate-intensity continuous training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
The intervals of high intensity are conducted between 90 and 95 % of heart rate maximum (HRmax) and resting between 50 and 60 % of the HRmax 15 loads of 30 seconds at high intensity, with 60 seconds of recovery at loads of moderate intensity.
Moderate-intensity continuous trainingBehavioural
The continuous training will be carried out at an intensity between 65 and 75% of the HRmax.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | Not described Receives: Behavioral: High-intensity interval training |
| Moderate-intensity continuous training | Active comparator | Not described Receives: Behavioral: Moderate-intensity continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-esteem
Self-esteem will be measured by applying the Rosenberg self-esteem scale and according to the scores obtained, the individual will be classified as low self-esteem (<30 points) or normal (> 30 points). The internal consistency of the scale shows a Cronbach's alpha with values ranging between 0.83 and 0.88, and the reliability shows a test-retest correlation of 0.84. Therefore, there is high internal consistency and adequate temporal reliability. Supporting the validity (of construct and known groups) of the instrument.
Measured: Change from baseline and after 8 weeks
Secondary outcomes (1)
Change in muscle mass
Muscle Mass will be quantified through an Omron® HBF510 bioelectrical impedance scale, which has a capacity of 0 to 150 kg, an accuracy of 100 gr for the calculation of weight.
Measured: Change from baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start26 Feb 2018
- Primary completion28 Jan 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Arboleda Serna, Universidad de Antioquia
- Investigators
- Elkin F Arango, MD. MsC, Study director, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852043
- Sponsor's protocol ID
- HIIT3_AFIS-UdeA
- Status last verified
- Jun 2019
- First submitted
- 12 Feb 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a HIIT Program Compared to MICT on the Self-esteem, Basal Metabolic Rate and Muscle Mass in Women 18 to 44 Years Old With Overweight or Obesity, Over a Period of 8 Weeks: a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT03852043
- Acronym / sponsor ID
- HIIT3_AFIS-UdeA
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overweight and obesity are a public health problem for society, reflected by an increase in its prevalence worldwide, being more frequent in women and related to low levels of self-esteem, accumulation of subcutaneous fat and internal organs, reduction of muscle mass (MM) and basal metabolic rate (BMR). Women are more predisposed to present weight gain because they are metabolically less efficient, have greater food intake, greater physical inactivity, and genetic factors. The different methods of physical training used for weight control are continuous training (CT) and the high-intensity interval training (HIIT). Both CT and HIIT have shown benefits without finding superiority of any of these methods. Nevertheless, there is a trend to the use HIIT programs, since they are more time-efficient and supports their use to induce physiological and metabolic adaptations over time, since this is a barrier to adherence to exercise programs. Overweight and obesity causes individual alterations in body composition and exercise leads to increase in MM, increase in caloric expenditure during the training session and increase in BMR due to the onset of muscle growth, secondary to an increase in the activity of the mitochondrial enzymes (greater mitochondrial biogenesis in the muscle), adaptations that could depend on the type of exercise, its intensity and the volume of it, but it is not clear due to the lack of evidence regarding this.
The primary objective of this study is to demonstrate that a HIIT program of short duration in a real-world setting has a standardized mean difference (SMD) higher than 0.84 in the improvement of self-esteem when comparing with a moderate-intensity continuous training (MICT) in women 18 to 44 years with overweight and obesity and low self-esteem, during eight weeks.
The secondary objective is to demonstrate that a low-volume HIIT in a real-world setting improves MM in 2% compared with MICT during a period of eight weeks in women 18 to 44 years.
Detailed description
Fifty women with low self-esteem will be randomly assigned to one of two training programs (MICT or HIIT) in a real-world setting. Both groups will perform three times a week for eight-weeks on alternate days.
The women in each group will perform three workouts per week for a period of eight weeks. The moderate-intensity continuous training group will perform a training session of 40 min duration at an intensity between 65 and 75% of your HRmax. Women assigned to the group HIIT will perform a training session of 22 minutes of duration by performing intervals of high intensity between 90 and 95 % of the HRmax for 30 seconds in duration and with a recovery of one minute training at moderate intensity is between 50 and 60 % of the HRmax, doing 15 loads of 30 seconds at high intensity, with 60 seconds of recovery between loads at moderate intensity. At the beginning of each training session, both groups will complete strength exercises mainly including large muscle groups (hip, knees, and ankles) with Theraband® (blue color ) for 3 sets of 15 repetitions.
All participants will be evaluated before initiating interventions and upon completion of the training program, after eight weeks, self-esteem will be assessed using the Rosenberg self-esteem scale, determination of anthropometric variables such as weight, height, waist circumference, arterial pressure, body composition by bioimpedance and the basal metabolic rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Behavioral: High-intensity interval training |
| Moderate-intensity continuous training | Active comparator | Behavioral: Moderate-intensity continuous training |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women 18 to 44 years old, overweighted (BMI ≥ 25 kg / m2) who agree to participate by signing the informed consent, no more than 600 Met / physical activity min / wk (be quantified with the Global Physical Activity Questionnaire - GPAQ), and have less than 30 points on the self-esteem scale.
Key exclusion criteria (1 listed)
- History of uncontrolled noncommunicable diseases (hypothyroidism, diabetes, asthma and high blood pressure, cardiac arrhythmias), motor disorders or sensitive to hinder the exercise, consumption of anticoagulants, medication altering heart rate (beta-blockers, calcium antagonists, bronchodilators), steroid use, abuse of psychoactive substances, personal history of surgical procedures in the last three months, depressive disorders; pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingThe intervals of high intensity are conducted between 90 and 95 % of heart rate maximum (HRmax) and resting between 50 and 60 % of the HRmax 15 loads of 30 seconds at high intensity, with 60 seconds of recovery at loads of moderate intensity. | Behavioural | High-intensity interval training |
| Moderate-intensity continuous trainingThe continuous training will be carried out at an intensity between 65 and 75% of the HRmax. | Behavioural | Moderate-intensity continuous training |
Primary outcome
Change in self-esteem
Time frame: Change from baseline and after 8 weeks
Self-esteem will be measured by applying the Rosenberg self-esteem scale and according to the scores obtained, the individual will be classified as low self-esteem (<30 points) or normal (> 30 points). The internal consistency of the scale shows a Cronbach's alpha with values ranging between 0.83 and 0.88, and the reliability shows a test-retest correlation of 0.84. Therefore, there is high internal consistency and adequate temporal reliability. Supporting the validity (of construct and known groups) of the instrument.
1 secondary outcome
Change in muscle mass
Time frame: Change from baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elkin F Arango, MD. MsC study director
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Moderate-intensity continuous training in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-esteem (time frame: Change from baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019; AzTrials last refreshed its copy on 1 Nov 2026.