- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05281822
The Stress Management Training Provided to Obese Women
March 15, 2022 updated by: Sukran Ertekin Pinar, Cumhuriyet University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sivas, Turkey, 58140
- Sukran Ertekin Pinar
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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10 months
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Styles of Coping with Stress Inventory
Time Frame: 10 months
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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.
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10 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sukran Ertekin Pinar, Cumhuriyet University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
October 30, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
March 15, 2022
First Posted (Actual)
March 16, 2022
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- TR SIVAS 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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