The Effect of Six Weeks of Sprint Exercise Snacks on Cardiometabolic Health and Cardiorespiratory Fitness in Inactive Overweight and Obese Female University Students: A Randomized Controlled Trial

The primary objective is to investigate the effect of six weeks of sprint exercise snacks on cardiometabolic health and cardiorespiratory fitness in inactive overweight and obese female university students.

A randomized controlled trial with a parallel two-arm design (intervention and control) on 44 inactive overweight and obese female students. Block randomization is performed using statistical software, with allocation concealment via sealed opaque envelopes. Outcome assessors and the data analyst are blinded.

At the Al-Zahra Female Dormitory of Farhangian University, Zanjan. Outcome assessors and the data analyst are blinded.

Inactive female university students aged 19–26 years, residing in the dormitory of Farhangian University of Zanjan, with BMI 24.9–34.9 and physical activity <600 MET-min/week, no medical contraindication for vigorous activity, no known cardiovascular, metabolic, or neuromuscular diseases, providing written informed consent. Exclusion criteria: pregnancy or lactation, active cardiovascular or musculoskeletal disease preventing vigorous activity, use of metabolism-affecting medications, smoking and alcohol consumption, regular exercise program within 3 months prior, and acute illness at screening.

Intervention group (n=22): A 6-week sprint exercise snack protocol, 3 non-consecutive days/week. Control group (n=22): Maintaining usual lifestyle.

Cardiorespiratory fitness; Body fat percentage Waist circumference; Waist-to-height ratio; Blood lipid profile; Systolic and diastolic blood pressure; Fasting blood glucose; Insulin resistance index

Participants are allocated to the intervention and control groups using block randomization. The unit of randomization in this study is individual. To achieve balance between groups regarding key variables such as age and baseline body mass index, stratified randomization is used based on these variables. The random sequence is generated using statistical software, whereby numbers 1 to 44 are randomly assigned to the two groups. For allocation concealment, group assignment is performed by a third party not involved in the screening or intervention process and is kept in sealed, opaque envelopes. These envelopes are opened only upon participant entry into the study and after final confirmation of eligibility criteria. Furthermore, outcome assessors are blinded to the group allocation of participants.

Due to the nature of the exercise intervention in this study, full blinding (double-blind or triple-blind) is not feasible. Participants are aware of their assigned group (intervention or control), and this awareness is fully and transparently disclosed in the informed consent form. The principal investigator is also aware of group allocation due to responsibility for coordinating the protocol and supervising exercise sessions. Healthcare personnel and exercise practitioners (those responsible for implementing the protocol) are also aware of participants' group status. However, blinding is applied at two levels as follows: First, outcome assessors (including those responsible for anthropometric measurements, blood sampling, physical fitness tests, and questionnaire administration) are blinded to participants' group allocation and receive data only with identification codes. Second, the data analyst is also blinded to group allocation and performs statistical analyses on coded data without knowledge of group names. No independent Data Safety and Monitoring Committee (DSMB) was established in this study. Additionally, individuals responsible for drafting the manuscript will be aware of group allocation, but interpretation of results will be based on blinded statistical analyses.

داده‌های فردی ناشناس‌شده شرکت‌کنندگان (IPD)، پروتکل مطالعه، نقشه آنالیز آماری، فرم رضایت‌نامه آگاهانه و دیکشنری داده‌ها. داده‌های فردی شامل اطلاعات جمعیت‌شناختی، شاخص‌های آنتروپومتریک، متغیرهای خونی، فشار خون و نتایج آزمون‌های آمادگی جسمانی خواهد بود که به طور کامل غیرقابل شناسایی خواهند شد

It will begin 6 months after publication of the primary results and will continue for 5 years.

Academic researchers and investigators affiliated with scientific and research institutions

Data will be used solely for scientific and research purposes (e.g., meta-analysis or secondary data analysis). Requestors must submit a brief research proposal and sign a confidentiality agreement. Commercial use of the data is prohibited.

Dr. Khalil ollah Monikh (Principal Investigator), Farhangian University of Zanjan. Email: kh.moonikh@cfu.ac.ir. Phone: +98 912 441 1878.

The applicant sends a request form to the principal investigator's email. The request is reviewed by the research team (within a maximum of 2 weeks). Upon approval, a Data Transfer Agreement (DTA) is signed, and de-identified data will be provided to the applicant via a secure link.