ObesityNCT06123273
The Effect of Exercise-Oriented Training on Physical Activity Level and Exercise Awareness in Overweight and Obese Women
A study testing Exercise-oriented training in people with Obesity and Overweight, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of an exercise-oriented training on physical activity level and exercise awareness in overweight and obese women. Participants will randomized into intervention group (IG) and control group (CG) and followed-up for three months. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obesity, Overweight, Physical Inactivity
- What is being tested?
- Exercise-oriented training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 1 Mar 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI 25-34.9 g/m2
- Female
- Turkish
Who cannot join
- Individuals with disabilities to exercise
- pregnant/breastfeeding women
- Individuals with Stage 2-3 obesity (BMI >35 kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise-Oriented Training on Physical Activity Level and Exercise Awareness in Overweight and Obese Women: A Randomized-Controlled Trial
This study aimed to investigate the effect of an exercise-oriented training on physical activity level and exercise awareness in overweight and obese women. Participants will randomized into intervention group (IG) and control group (CG) and followed-up for three months. The International Physical Activity Questionnaire Short Form (IPAQ) will be applied to both groups at the beginning and end of the study to determine the level of physical activity, and the Exercise Health Belief Model Scale (EHBM) will be applied to evaluate the exercise awareness level, and anthropometric measurements (weight, body mass index, waist circumference) will recorded. The CG will receive no other interventions other than routine recommendations. The IG will be given face-to-face training to increase exercise awareness along with routine recommendations after the first meeting, and they will be contacted by phone every two weeks for three months.
Read the detailed description
Obesity and insufficient physical activity are among the most important health problems of today. Both obesity and physical inactivity are risk factors for many chronic diseases. This study aimed to investigate the effect of an exercise-oriented training on physical activity level and exercise awareness in overweight and obese women. Participants (n=112) were randomized into intervention group (IG) and control group (CG) and followed-up for three months. The International Physical Activity Questionnaire Short Form (IPAQ) was applied to both groups at the beginning and end of the study to determine the level of physical activity, and the Exercise Health Belief Model Scale (EHBM) was applied to evaluate the exercise awareness level, and anthropometric measurements (weight, body mass index, waist circumference) were recorded. The CG received no other interventions other than routine recommendations. The IG was given face-to-face training to increase exercise awareness along with routine recommendations after the first meeting, and they were contacted by phone every two weeks for three months.
- Conditions
- Obesity, Overweight, Physical Inactivity
- Being tested
- Exercise-oriented training
- Medical subject headings
- Obesity, Overweight, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-oriented trainingBehavioural
Also called close follow-up
IG received an exercise-oriented training with a 20-minute presentation including graphics, in line with clinical guidelines, in addition to routine recommendations. The training included information about the benefits of exercise and the harms of a sedentary life, the relationship between exercise and chronic diseases, suggestions to have a more active lifestyle and on how to exercise, the duration and form of exercise necessary for a healthy life, and the things to be considered while exercising. During the three-month follow-up, the subjects in the IG were called every two weeks to ask about their weight measurements, their level of exercise, and how much they walked. The subjects' questions, if any, were answered, and the interview was completed by making exercise suggestions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group was given an exercise-oriented training Receives: Behavioral: Exercise-oriented training |
| Control group | No intervention | The control group was given only routine recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The International Physical Activity Questionnaire Short Form was used to determine the physical activity level at the beginning and end of the study
The International Physical Activity Questionnaire Short Form was used to determine the physical activity level at the beginning and end of the study. The minimum score is <600 Maximal Exercise Test (MET) -minute/week while the maximum score is >3000 MET-minute/week . High score means high exercise belief.
Measured: 3 months
Secondary outcomes (3)
Exercise Health Belief Model Scale
Exercise Health Belief Model Scale was used to evaluate the exercise awareness levels of all participants. The minimum score is 25 while the maximum score is 125. High score means high exercise belief.
Measured: 3 months
Anthropometric measure
Body Mass Index was used as an anthropometric measurement. All of the participants were recorded . It is measured as weight in kilograms divided by height in meters squared.
Measured: 3 months
Body fat
body fat percentage were recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Aug 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Cayir, Ataturk University
- Investigators
- Zehranur Kacar, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123273
- Sponsor's protocol ID
- TTU-2021-9585
- Status last verified
- Nov 2023
- First submitted
- 5 Sep 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise-Oriented Training on Physical Activity Level and Exercise Awareness in Overweight and Obese Women: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT06123273
- Acronym / sponsor ID
- TTU-2021-9585
- Conditions
- Obesity, Overweight, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to investigate the effect of an exercise-oriented training on physical activity level and exercise awareness in overweight and obese women. Participants will randomized into intervention group (IG) and control group (CG) and followed-up for three months. The International Physical Activity Questionnaire Short Form (IPAQ) will be applied to both groups at the beginning and end of the study to determine the level of physical activity, and the Exercise Health Belief Model Scale (EHBM) will be applied to evaluate the exercise awareness level, and anthropometric measurements (weight, body mass index, waist circumference) will recorded. The CG will receive no other interventions other than routine recommendations. The IG will be given face-to-face training to increase exercise awareness along with routine recommendations after the first meeting, and they will be contacted by phone every two weeks for three months.
Detailed description
Obesity and insufficient physical activity are among the most important health problems of today. Both obesity and physical inactivity are risk factors for many chronic diseases. This study aimed to investigate the effect of an exercise-oriented training on physical activity level and exercise awareness in overweight and obese women. Participants (n=112) were randomized into intervention group (IG) and control group (CG) and followed-up for three months. The International Physical Activity Questionnaire Short Form (IPAQ) was applied to both groups at the beginning and end of the study to determine the level of physical activity, and the Exercise Health Belief Model Scale (EHBM) was applied to evaluate the exercise awareness level, and anthropometric measurements (weight, body mass index, waist circumference) were recorded. The CG received no other interventions other than routine recommendations. The IG was given face-to-face training to increase exercise awareness along with routine recommendations after the first meeting, and they were contacted by phone every two weeks for three months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Exercise-oriented trainingThe intervention group was given an exercise-oriented training |
| Control group | No intervention | –The control group was given only routine recommendations |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 25-34.9 g/m2
- Female
- Turkish
Key exclusion criteria (3 listed)
- Individuals with disabilities to exercise
- pregnant/breastfeeding women
- Individuals with Stage 2-3 obesity (BMI >35 kg/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-oriented trainingAlso: close follow-upIG received an exercise-oriented training with a 20-minute presentation including graphics, in line with clinical guidelines, in addition to routine recommendations. The training included information about the benefits of exercise and the harms of a sedentary life, the relationship between exercise and chronic diseases, suggestions to have a more active lifestyle and on how to exercise, the duration and form of exercise necessary for a healthy life, and the things to be considered while exercising. During the three-month follow-up, the subjects in the IG were called every two weeks to ask about their weight measurements, their level of exercise, and how much they walked. The subjects' questions, if any, were answered, and the interview was completed by making exercise suggestions. | Behavioural | Intervention group |
Primary outcome
The International Physical Activity Questionnaire Short Form was used to determine the physical activity level at the beginning and end of the study
Time frame: 3 months
The International Physical Activity Questionnaire Short Form was used to determine the physical activity level at the beginning and end of the study. The minimum score is <600 Maximal Exercise Test (MET) -minute/week while the maximum score is >3000 MET-minute/week . High score means high exercise belief.
3 secondary outcomes
Exercise Health Belief Model Scale
Time frame: 3 months
Anthropometric measure
Time frame: 3 months
Body fat
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zehranur Kacar principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-oriented training in people with Obesity and Overweight, run by Ataturk 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 3 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 8 Nov 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 International Physical Activity Questionnaire Short Form was used to determine the physical activity level at the beginning and end of the study (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2023.