NCT03852043

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

February 12, 2019

Last Update Submit

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

EXPERIMENTAL
Behavioral: High-intensity interval training

Moderate-intensity continuous training

ACTIVE COMPARATOR
Behavioral: Moderate-intensity continuous training

Interventions

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.

High-intensity interval training

The continuous training will be carried out at an intensity between 65 and 75% of the HRmax.

Moderate-intensity continuous training

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elkin F Arango, MD. MsC

    Universidad de Antioquia

    STUDY DIRECTOR

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

Locations