Obesity &Amp; OverweightNCT07184177
Validation of Heart Rate Monitors in Overweight and Obese Young Adults
An observational study of Obesity &Amp; Overweight, run by Universidad Autonoma de Baja California.
Trial summary
Overweight and obesity are defined as an excessive accumulation of body fat that affects health. According to data from the World Health Organization (WHO), in 2022, there were 2.5 billion adults aged 18 years and older who were overweight, of whom 890 million were obese. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Obesity &Amp; Overweight
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2026to 4 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
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 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: Sedentary young adults aged between 18 and 35 years, all of whom will have a body mass index (BMI) ≥ 25 kg/m2. Participants will be recruited through snowball sampling.
Who may be able to join
- Body mass index ≥ 25 kg/m2
- Energy expenditure < 600 METs a week
- Acceptance of informed consent
Who cannot join
- ≥100 mL of alcohol consumption per week
- Have limitations to perform regular physical activity
- Have a chronic non-communicable disease
- Answer "yes" to any of the questions on the Physical Activity Readiness-Questionnaire for Everyone (PAR-Q+), which represents a health risk.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of the Accuracy of Heart Rate Monitors at Resting and Exercise at Maximal Fat Oxidation Rate in Overweight and Obese Young Adults
Overweight and obesity are defined as an excessive accumulation of body fat that affects health. According to data from the World Health Organization (WHO), in 2022, there were 2.5 billion adults aged 18 years and older who were overweight, of whom 890 million were obese. In other words, 43% of adults aged 18 years and older were overweight, and 16% of them were obese.
Overweight and obesity are key risk factors for various chronic diseases such as diabetes, hypertension, cardiovascular disease, and even some types of cancer. There is evidence that mortality from cardiovascular disease, and the incidence of cancer and diabetes, varies according to the amount of physical activity. In the context of high levels of sedentary time, higher levels of moderate to vigorous physical activity are recommended. There are various ways to treat overweight and obesity, the main ones usually being lifestyle changes, such as following a healthy diet and regular physical activity, as well as following pharmacological treatments. In this project, the focus will be on the fat metabolism generated during moderate physical activity.
Read more
There are physical activity interventions aimed at increasing fat metabolism that may potentially reduce the symptoms of metabolic diseases such as obesity and type 2 diabetes. For this purpose, it is important to understand the factors that increase or decrease fat oxidation. Factors such as exercise intensity and duration are important to understand when determining maximum fat oxidation (FatMax).
The aim is to develop comprehensive research that will generate knowledge and evidence on health issues with social impact through the evaluation of commercial technologies and innovative actions that promote the prevention, treatment, and resolution of national health problems such as obesity.
- Conditions
- Obesity &Amp; Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Validation group | Participants to validate 10 heart rate monitors against electrocardiogram at resting and exercise at a maximal fat oxidation rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate at maximal fat oxidation
Gas exchange and heart rate will be recorded throughout the exercise tests, while the rate of perceived exertion will be registered at the end of each stage using the modified Borg scale with a 0-10 rating. The average VO2 and VCO2 values of the last 2 min of each stage before RER ≥ 1.0 will be used to calculate fat and carbohydrate oxidation using the stoichiometric equations of Jeukendrup and Wallis. The maximum rate of fat oxidation and its corresponding intensity during exercise will be determined by mathematical modeling of fat oxidation kinetics, plotted against oxygen consumption (% VO2max). The symmetry, amplitude, and translation parameters of the curve will be calculated as well to represent the oxidative capacity of each subject.
Measured: 30 minutes
Resting heart rate
Resting heart rate of participants using 10 different heart rate monitors
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start19 Jan 2026 (estimated)
- Primary completion5 Jun 2026 (estimated)
- Study completion4 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity &Amp; OverweightStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Antonio Hernández Lepe, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184177
- Sponsor's protocol ID
- Validation Heart Rate Monitors
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of original article in an indexed journal with impact factor (JCR) over 2.0.
Publications
Chavez-Guevara IA, Amaro-Gahete FJ, Ramos-Jimenez A, Brun JF. Toward Exercise Guidelines for Optimizing Fat Oxidation During Exercise in Obesity: A Systematic Review and Meta-Regression. Sports Med. 2023 Dec;53(12):2399-2416. doi: 10.1007/s40279-023-01897-y. Epub 2023 Aug 16.
PubMed 37584843Hernandez-Lepe MA, Hernandez-Ontiveros DA, Chavez-Guevara IA, Ramos-Jimenez A, Hernandez-Torres RP, Lopez-Fregoso RJ, Ramos-Lopez O, Amaro-Gahete FJ, Muniz-Salazar R, Olivas-Aguirre FJ. Impact of Exercise Training at Maximal Fat Oxidation Intensity on Metabolic and Epigenetic Parameters in Patients with Overweight and Obesity: Study Protocol of a Randomized Controlled Trial. J Funct Morphol Kinesiol. 2024 Oct 31;9(4):214. doi: 10.3390/jfmk9040214.
PubMed 39584867Chavez-Guevara IA, Urquidez-Romero R, Perez-Leon JA, Gonzalez-Rodriguez E, Moreno-Brito V, Ramos-Jimenez A. Chronic Effect of Fatmax Training on Body Weight, Fat Mass, and Cardiorespiratory Fitness in Obese Subjects: A Meta-Analysis of Randomized Clinical Trials. Int J Environ Res Public Health. 2020 Oct 28;17(21):7888. doi: 10.3390/ijerph17217888.
PubMed 33126461