Obese WomenNCT05281822
The Stress Management Training Provided to Obese Women
A study testing The stress management training in people with Obese Women and Stress, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Obesity, which is an important public healthcare issue, can affect women's physical, mental, social health, stress level, and coping negatively. Aim: The present study was conducted to determine the effects of stress management training provided to obese women on eating attitudes, stress, and coping with… Read more about this study
- Who is it for?
- Ages 23 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese Women, Stress, Training
- What is being tested?
- The stress management training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Oct 2019
- 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 23 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who lived in the city center,
- Body Mass Index ≥30,
- Having no perception and communication problems and being able to answer questions,
- Women who volunteered to participate in the study
Who cannot join
- Being a man
- Non-obese women and those with a body mass index below 30
- Those with communication problems
- Those who do not live in the city center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sivas Cumhuriyet University, Faculty of Health Sciences
Introduction: Obesity, which is an important public healthcare issue, can affect women's physical, mental, social health, stress level, and coping negatively.
Aim: The present study was conducted to determine the effects of stress management training provided to obese women on eating attitudes, stress, and coping with stress.
Read the detailed description
Methods: The sampling of the randomized controlled experimental study based on the pre-test and post-test model consisted of 70 women (experimental = 35; control = 35) with a Body Mass Index ≥30, who applied to a Community Healthcare Center Obesity Unit in primary care in Turkey. The data were collected by using Personal Information Form, Perceived Stress Scale, Stress Coping Styles Scale, Dutch Eating Behavior Questionnaire, and height-weight measurements.
- Conditions
- Obese Women, Stress, Training
- Being tested
- The stress management training
- Keywords
- women, obesity, stress, stress management training, eating attitude
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The stress management trainingOther
The women in the experimental group were provided with stress management training to help cope with stress conditions how to use positive coping in conditions in case of stress and tension.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The BMI (kg/m2) was calculated by measuring the height and weight of the women in the experimental groups. Then, the women in the experimental group were provided with stress management training to help cope with stress conditions, how to use positive coping in conditions in case of stress and tension. In terms of the reliability of the training, each woman was interviewed face-to-face, which lasted for 30-40 minutes. Receives: Other: The stress management training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The scale consisted of 10 items, scored between 1-5 and the total score is calculated between 10-50. As the score increases, the stress level also increases.
Measured: 10 months
Styles of Coping with Stress Inventory
The scale, which consists of a total of 30 items, is scored between 0-3. The scores of each sub-dimension are calculated separately, the total score is not calculated.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Jan 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese WomenStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Ertekin Pinar, Cumhuriyet University
- Investigators
- Sukran Ertekin Pinar, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281822
- Sponsor's protocol ID
- TR SIVAS 01
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 16 Mar 2022
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sivas Cumhuriyet University, Faculty of Health Sciences
- ClinicalTrials.gov ID
- NCT05281822
- Acronym / sponsor ID
- TR SIVAS 01
- Conditions
- Obese Women, Stress, Training
- Keywords
- women, obesity, stress, stress management training, eating attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 16 Mar 2022 (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.
Introduction: Obesity, which is an important public healthcare issue, can affect women's physical, mental, social health, stress level, and coping negatively.
Aim: The present study was conducted to determine the effects of stress management training provided to obese women on eating attitudes, stress, and coping with stress.
Detailed description
Methods: The sampling of the randomized controlled experimental study based on the pre-test and post-test model consisted of 70 women (experimental = 35; control = 35) with a Body Mass Index ≥30, who applied to a Community Healthcare Center Obesity Unit in primary care in Turkey. The data were collected by using Personal Information Form, Perceived Stress Scale, Stress Coping Styles Scale, Dutch Eating Behavior Questionnaire, and height-weight measurements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: The stress management trainingThe BMI (kg/m2) was calculated by measuring the height and weight of the women in the experimental groups. Then, the women in the experimental group were provided with stress management training to help cope with stress conditions, how to use positive coping in conditions in case of stress and tension. In terms of the reliability of the training, each woman was interviewed face-to-face, which lasted for 30-40 minutes. |
Who may qualify
- Ages
- 23 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women who lived in the city center,
- Body Mass Index ≥30,
- Having no perception and communication problems and being able to answer questions,
- Women who volunteered to participate in the study
Key exclusion criteria (4 listed)
- Being a man
- Non-obese women and those with a body mass index below 30
- Those with communication problems
- Those who do not live in the city center
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 |
|---|---|---|
| The stress management trainingThe women in the experimental group were provided with stress management training to help cope with stress conditions how to use positive coping in conditions in case of stress and tension. | Other | Experimental group |
Primary outcome
Perceived Stress Scale
Time frame: 10 months
The scale consisted of 10 items, scored between 1-5 and the total score is calculated between 10-50. As the score increases, the stress level also increases.
Styles of Coping with Stress Inventory
Time frame: 10 months
The scale, which consists of a total of 30 items, is scored between 0-3. The scores of each sub-dimension are calculated separately, the total score is not calculated.
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 16 Mar 2022.
- 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.
Sukran Ertekin Pinar principal investigator
Cumhuriyet 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 The stress management training in people with Obese Women and Stress, run by Cumhuriyet 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 4 inclusion and 4 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 16 Mar 2022. 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?
Perceived Stress Scale (time frame: 10 months). The study lists 2 primary outcomes in all. 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 16 Mar 2022.