High-intensity Interval Training on the Self-esteem, Basal Metabolic Rate and Muscle Mass in Overweight Women.
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.
1 other identifier
interventional
28
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started Feb 2018
Typical duration for not_applicable healthy-volunteers
1 active site
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
February 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2019
CompletedFirst Submitted
Initial submission to the registry
February 12, 2019
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2019
CompletedJune 10, 2019
June 1, 2019
11 months
February 12, 2019
June 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline and after 8 weeks
Secondary Outcomes (1)
Change in muscle mass
Change from baseline and after 8 weeks
Other Outcomes (1)
Change in basal metabolic rate
Change from baseline and after 8 weeks
Study Arms (2)
High-intensity interval training
EXPERIMENTALModerate-intensity continuous training
ACTIVE COMPARATORInterventions
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.
The continuous training will be carried out at an intensity between 65 and 75% of the HRmax.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad de Antioquia
Medellín, Antioquia, Colombia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elkin F Arango, MD. MsC
Universidad de Antioquia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 12, 2019
First Posted
February 22, 2019
Study Start
February 26, 2018
Primary Completion
January 28, 2019
Study Completion
April 5, 2019
Last Updated
June 10, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share