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ObesityNCT06004427

Investigation of the Effectiveness of Resistance Exercise Program Given With Diet in Obese Individuals.

A study testing Diet program and Exercise training protocols in people with Obesity, run by Uskudar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to examine the effects of diet and combined resistance exercise training on physical activity and sleep patterns compared to diet program alone. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Diet program and Exercise training protocols
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2023to 20 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • be 18 years or older.
  • Having a Body Mass Index of 30 or higher.
  • To have accepted the voluntary consent form that requires participation in the study.

Who cannot join

  • Any neurological or psychological problems.
  • Do not accept the voluntary consent form.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Üsküdar Unıversıty

    Üsküdar, Istanbul

Other trials in Turkey (Türkiye)

About this study

The aim of this study is to examine the effects of diet and combined resistance exercise training on physical activity and sleep patterns compared to diet program alone.

Read the detailed description

The study was planned as a randomized controlled trial. The groups will be divided into two as control group and exercise group by simple randomization method.While the normal diet program will be applied to the obese individuals in the control group, the individuals in the exercise group will be given resistance exercise training together with the diet program.Before and after the treatment, fatigue severity scale pittsburgh sleep quality scale international physical activity index questionnaires will be applied to the participants.In addition, sociodemographic characteristics and waist circumference measurement will be recorded. After the 12-week diet program, the data of the participants will be compared by making statistical analysis.

Conditions
Obesity
Being tested
Diet program, Exercise training protocols
Keywords
resistant exercise, diet
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet programOther

    A diet program will be prepared with the help of a dietitian at the beginning of 12 weeks for all participants who agree to participate in the study, and this program will be controlled by a dietitian once a month and completed at the end of 12 weeks.

  • Exercise training protocolsOther

    calisthenic exercises exercises with lower and upper extremity theraband exercises with light dumbbells

Study groups in NCT06004427
Study groupRoleWhat they receive
control groupActive comparatorregular diet program
Receives: Other: Diet program
exercise groupExperimentalresistance exercise program
Receives: Other: Diet program; Other: Exercise training protocols

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Pittsburgh Sleep Quality Index (PSQI)

    The scale is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"

    Measured: 13 weeks

  2. Fatigue Severity Scale (FSS)

    There are 9 questions in the scale and each question consists of 7 points. The scale determines the fatigue status of individuals in the last 1 month. Questions are scored as Strongly disagree - Totally agree. The scale score is the average value of the questions. If the average score is 5 and above, it is considered as "fatigue".

    Measured: 13 weeks

  3. International Physical Activity Questionnaire - Short Form

    This questionnaire is a standardized tool for measuring physical activity, developed by researchers from various countries with the support of the World Health Organization (WHO) and Centers for Disease Control (CDC). Questionnaire, four areas of physical activity; It covers work, transportation, housework/gardening, and leisure activities, but also includes questions about time spent sitting as an indicator of inactivity. In each of the four areas, the energy expended in moderate and vigorous activities in the last 7 days, the number of days the activities were performed, and the number of activities performed during the day are recorded. The times are multiplied by the Metabolic Equivalent (MET) values per activity, and the results for all items are added to form the overall physical activity score. The question about sitting is not included in the physical activity score. Classification is made in three categories as physically inactive (3000 MET min/week).

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion30 Nov 2023
  4. Study completion20 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
resistance training (RT), (3 days/wk, 3 sets/day, 8-12 repetitions/set)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004427
Sponsor's protocol ID
Uskudar74
Status last verified
Dec 2023
First submitted
15 Aug 2023
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Waters DL, Aguirre L, Gurney B, Sinacore DR, Fowler K, Gregori G, Armamento-Villareal R, Qualls C, Villareal DT. Effect of Aerobic or Resistance Exercise, or Both, on Intermuscular and Visceral Fat and Physical and Metabolic Function in Older Adults With Obesity While Dieting. J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):131-139. doi: 10.1093/gerona/glab111.

    PubMed 33839788

  • Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Sweeney FC, Stewart C, Buchanan TA, Spicer D, Tripathy D, Bernstein L, Mortimer JE. Aerobic and resistance exercise improves physical fitness, bone health, and quality of life in overweight and obese breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2018 Oct 19;20(1):124. doi: 10.1186/s13058-018-1051-6.

    PubMed 30340503

  • Soriano-Maldonado A, Martinez-Forte S, Ferrer-Marquez M, Martinez-Rosales E, Hernandez-Martinez A, Carretero-Ruiz A, Villa-Gonzalez E, Barranco-Ruiz Y, Rodriguez-Perez MA, Torrente-Sanchez MJ, Carmona-Rodriguez L, Soriano-Maldonado P, Vargas-Hitos JA, Casimiro-Andujar AJ, Artero EG, Fernandez-Alonso AM. Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Mar;99(12):e19427. doi: 10.1097/MD.0000000000019427.

    PubMed 32195937

  • Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.

    PubMed 28514618

  • Willis LH, Slentz CA, Bateman LA, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Effects of aerobic and/or resistance training on body mass and fat mass in overweight or obese adults. J Appl Physiol (1985). 2012 Dec 15;113(12):1831-7. doi: 10.1152/japplphysiol.01370.2011. Epub 2012 Sep 27.

    PubMed 23019316

  • Bugday B, Celik AL, Safran EE, Sevgin O. Impact of resistance exercise and diet on physical activity, sleep, and fatigue in obese individuals: a randomized controlled trial. BMC Public Health. 2025 Jul 2;25(1):2282. doi: 10.1186/s12889-025-23549-8.

    PubMed 40604657

Questions about this trial

What is this clinical trial studying?

A study testing Diet program and Exercise training protocols in people with Obesity, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Pittsburgh Sleep Quality Index (PSQI) (time frame: 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06004427, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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