NCT07811596

Brief Summary

Obesity is a complex disease and a major risk factor for cardiovascular and metabolic disorders, particularly atherosclerosis, type II diabetes, and metabolic syndrome; it is also associated with an increased risk of mortality. In addition, obesity is a multifaceted health problem that can adversely affect psychological well-being over time. It may contribute to a sustained vicious cycle by reducing self-esteem, impairing sleep quality, and increasing perceived stress. Hormonal changes occurring during the aging process further emphasize the importance of early intervention for obesity. In this context, incorporating both diet and exercise into daily life represents a powerful strategy for combating obesity. Lack of time is considered one of the major barriers to regular participation in exercise programs. Today, factors such as sedentary lifestyles, demanding work schedules, inadequate stress-coping mechanisms, and impaired body image may reduce individuals' awareness of weight management and healthy living while making it more difficult to develop appropriate strategies. This situation has led researchers to focus on exercise methods that can be implemented effectively within a short period of time. Recent studies have particularly highlighted the High-Intensity Interval Training (HIIT) model, which offers time-efficient exercise. Scientific evidence suggests that HIIT is an effective and time-efficient exercise approach for combating obesity. The aim of this study is to investigate the effects of implementing a feasible HIIT training program through supervised online (individualized online training under physiotherapist supervision) and unsupervised (individual home-based exercise) approaches on changes in body mass index, waist-to-hip ratio, self-esteem, sleep quality, perceived exertion during exercise, physical activity levels, stress management, and motivation to engage in physical activity. Furthermore, the study aims to implement HIIT training without restrictive dietary support to promote the long-term sustainability of a healthy lifestyle. Our goal is to enhance the integration of exercise into daily life under feasible conditions and to achieve positive outcomes among participants.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2026Oct 2026

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Expected
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

September 3, 2026

Last Update Submit

September 9, 2026

Conditions

Keywords

overweighthigh-intensity interval training (HIIT)obesityweight management

Outcome Measures

Primary Outcomes (1)

  • International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire (IPAQ) is a standardized instrument developed by the International Consensus Group in 1997-1998 with the support of the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) to assess physical activity and sedentary behavior. The questionnaire can be administered to individuals aged 15-69 years. It assesses three main types of physical activity performed for at least 10 minutes during the previous seven days: walking, moderate-intensity activities, and vigorous-intensity activities, as well as the amount of time spent sedentary on an average day. A separate metabolic equivalent of task (MET) score is calculated for each activity category and then summed. The MET score is calculated by multiplying the MET value of the activity by the number of days and minutes performed. The results are categorized into three levels of physical activity: inactive, moderately active, and active. The questionnaire h

    Baseline and 6 weeks

Secondary Outcomes (6)

  • Waist-to-Hip Ratio (WHR)

    Baseline and 6 weeks

  • Skinfold Thickness Measurement for Body Fat Percentage and Circumference Measurements

    Baseline and 6 weeks

  • Pittsburgh Sleep Quality Index (PSQI)

    Baseline and 6 weeks

  • Perceived Stress Scale (PSS)

    Baseline and 6 weeks

  • Rosenberg Self-Esteem Scale (RSES)

    Baseline and 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Physiotherapist-Supervised Online Exercise Group (Supervised)

EXPERIMENTAL

The researchers will contact the participants assigned to this group and establish an exercise training schedule consisting of two sessions per week. The sessions will be conducted via the Zoom platform without recording. A standardized 7-minute warm-up and cool-down period will be included in each session. Throughout each session, the researcher will guide the participants to perform the exercises with correct posture and in accordance with biomechanical principles within the prescribed duration. In addition, participants' general health status will be monitored, and motivational support and guidance will be actively provided through WhatsApp groups and at the end of each session. Outcome assessments will be conducted face-to-face before the intervention and at the end of the six-week intervention period.

Other: High-Intensity Interval Training (HIIT)

Individual Home-Based Exercise Group (Unsupervised)

ACTIVE COMPARATOR

The physiotherapist-supervised online exercise program will first be explained to the participants in this group by the physiotherapist, followed by a single practical session conducted together. Subsequently, the program will be provided as a brochure for participants to perform as a home-based exercise program. Throughout the intervention period, participants will be contacted regarding the progress of the exercise training. Their general health status will be monitored, and motivational support and guidance will be actively provided through WhatsApp groups and online consultations. Outcome assessments will be conducted face-to-face before the intervention and at the end of the six-week intervention period.

Other: High-Intensity Interval Training (HIIT)

Interventions

High-Intensity Interval Training (HIIT) is a time-efficient exercise approach based on alternating short bouts of high-intensity exercise with low-intensity recovery intervals. HIIT protocols may vary in terms of exercise intensity, work-to-recovery duration, number of repetitions, and exercise frequency, and can be individualized according to an individual's physical capacity. Particularly among overweight and obese individuals, time constraints are considered a major barrier to regular participation in exercise; therefore, HIIT has emerged as an alternative to traditional moderate-intensity continuous exercise due to its ability to be implemented within a shorter period of time. Current scientific evidence indicates that HIIT can improve cardiorespiratory fitness and aerobic capacity, enhance exercise tolerance, and produce beneficial effects on certain metabolic parameters. However, HIIT is not consistently superior to moderate-intensity continuous exercise in terms of body weight a

Individual Home-Based Exercise Group (Unsupervised)Physiotherapist-Supervised Online Exercise Group (Supervised)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • Body Mass Index (BMI) between 25 and 39.9 kg/m²
  • Ability to use a mobile application for online exercise training
  • Literacy

You may not qualify if:

  • Individuals currently participating in any exercise and/or dietary program
  • Individuals diagnosed with a health condition that prevents them from exercising
  • Individuals with any systemic or orthopedic condition that contraindicates high-intensity exercise
  • Pregnancy
  • Individuals with cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Medipol University

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Moro T, Marcolin G, Bianco A, Bolzetta F, Berton L, Sergi G, Paoli A. Effects of 6 Weeks of Traditional Resistance Training or High Intensity Interval Resistance Training on Body Composition, Aerobic Power and Strength in Healthy Young Subjects: A Randomized Parallel Trial. Int J Environ Res Public Health. 2020 Jun 8;17(11):4093. doi: 10.3390/ijerph17114093.

    PMID: 32521745BACKGROUND
  • Chin EC, Yu AP, Lai CW, Fong DY, Chan DK, Wong SH, Sun F, Ngai HH, Yung PSH, Siu PM. Low-Frequency HIIT Improves Body Composition and Aerobic Capacity in Overweight Men. Med Sci Sports Exerc. 2020 Jan;52(1):56-66. doi: 10.1249/MSS.0000000000002097.

    PMID: 31343521BACKGROUND

MeSH Terms

Conditions

OverweightObesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 10, 2026

Study Start

March 1, 2026

Primary Completion

September 30, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The data will not be shared in order to ensure confidentiality and security.

Locations