Brief InterventionNCT05978323
The Effect of a Brief Intervention on Behavıoral Change, Anthropometric and Metabolic Variables
A study testing Brief intervention in people with Brief Intervention, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate the effect of a brief intervention on anthropometric and metabolic changes in overweight women with low health literacy. The total number of samples was determined as 88. It was decided to recruit a total of 124 people, 62 people in each group, with a 40% loss in the groups. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Brief Intervention
- What is being tested?
- Brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2023to 9 Oct 2024
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having heart disease, stroke, and chronic kidney failure diagnosed by a physician,
- Having diabetes that requires the use of insulin,
- Having hypothyroidism that prevents weight loss,
- Participating in a weight management program in the last 3 months,
- Being diagnosed with a disease that causes deterioration in cognitive processes such as Alzheimer's and dementia,
- Having a diagnosed physical or neurological problem that prevents him from doing physical activity,
- People who plan to become pregnant or become pregnant during the trial period (8 months after enrollment in the trial)
Who cannot join
- Between 12.09.2023 and 24.06.2024 two Primary healthcare organization applied,
- Volunteered to participate in the research,
- Women between the ages of 30-65,
- The level of health literacy is limited-restricted,
- 25≥ BMI < 30,
- Those who can read and understand Turkish will be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Brief Interventıon on Behavıoral Change, Anthropometrıc and Metabolıc Varıables In Overweıght Women wıth Low Health Lıteracy
This study will evaluate the effect of a brief intervention on anthropometric and metabolic changes in overweight women with low health literacy. The total number of samples was determined as 88. It was decided to recruit a total of 124 people, 62 people in each group, with a 40% loss in the groups. Brief intervention interviews will be conducted with the intervention group. Brief intervention interviews will take an average of 20-30 minutes and four times. The control group will not be intervened except for the first and last evaluations.
Read the detailed description
This study will evaluate the effect of a brief intervention on anthropometric and metabolic changes in overweight women with low health literacy. The total number of samples was determined as 88, 44 in each of the intervention and control groups. It was decided to recruit a total of 124 people, 62 people in each group, with a 40% loss in the groups. Randomization will be performed after obtaining consent from the participants who meet the eligibility and exclusion criteria. The sampled individuals will be assigned to the Intervention and Control groups according to the block randomization method. Brief intervention interviews will be conducted with the intervention group. It was determined as the first evaluation and the follow-ups on the 1st day, 15th day, 1st month, 3rd month, and the last evaluation (6th month). Brief interventions, 5A for those who are ready to change their behavior (Ask, Advise, Assess, Assist, Arrange); those who are not ready to change their behavior 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) model will be used. At the end of brief interventions applied to overweight women with low health literacy for 20-30 minutes, a total of four times; weight change, waist circumference change, blood pressure change, blood glucose change, blood lipid change, diet, and exercise behaviors will be evaluated. The control group will not be intervened except for the first and last evaluations.
- Conditions
- Brief Intervention
- Being tested
- Brief intervention
- Keywords
- Brief intervention, Overweight, Health literacy, Weight change, Metabolic variables
- Medical subject headings
- Overweight, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionBehavioural
Short face-to-face intervention interviews will be conducted with individuals in the intervention group. Interviews will be held in primary healthcare organizations' meeting rooms. Brief intervention interviews will be conducted with the intervention group. It was determined as the first evaluation and the follow-ups on the 1st day, 15th day, 1st month, 3rd month, and the last evaluation (6th month). Brief interventions, 5A for those who are ready to change their behavior (Ask, Advise, Assess, Assist, Arrange); Those who are not ready to change their behavior 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) model will be used. Brief intervention interviews will take an average of 20-30 minutes. The talks will include awareness of overweight and obesity, a healthy diet, and exercise. By the researcher's prepared will be used for individuals with low health literacy educational materials.
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention | Experimental | Intervention Group: Short face-to-face intervention interviews will be conducted with individuals in the intervention group. Interviews will be held in primary healthcare organizations' meeting rooms. Brief intervention interviews will be conducted with the intervention group. It was determined as the first evaluation and the follow-ups on the 1st day, 15th day, 1st month, 3rd month, and the last evaluation (6th month). Brief interventions, 5A for those who are ready to change their behavior (Ask, Advise, Assess, Assist, Arrange); Those who are not ready to change their behavior 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) model will be used. Brief intervention interviews will take an average of 20-30 minutes. The talks will include awareness of overweight and obesity, a healthy diet, and exercise. By the researcher's prepared will be used for individuals with low health literacy educational materials. Receives: Behavioral: Brief intervention |
| Control | No intervention | The control group will not be intervened except for the first and last face-to-face evaluation. At the end of the research, training materials for weight loss will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of weight change
The weight will be evaluated by measuring the weight.
Measured: Change from before implementation three and six months of practice.
Secondary outcomes (9)
The exercise habits will be evaluated using the Exercise Behavior Change Model Scales.
The highest score that can be obtained from the scale is 140, and the lowest score is 28. The higher the scale score indicates that the individual's chance of being successful in change increases.
Measured: Change from before implementation and six months of practice.
The eating habits will be evaluated using the Nutrition Processes of Change Scale.
The highest score that can be obtained from the scale is 240, and the lowest score is 48. Higher scores from the scale indicate more positive values for change.
Measured: Change from before implementation and six months of practice.
The Mediterranean diet will be evaluated using the Mediterranean Diet Adherence Screener (MEDAS).
A total score of 7 and 8 on the scale indicates an acceptable degree of adherence to the Mediterranean diet, and a score of 9 and above indicates strict adherence to the Mediterranean diet.
Measured: Change from before implementation and six months of practice.
Waist circumference measurement and evaluation
Waist circumference will be measured by the researcher with a tape measure from the thinnest part of the waist at the level of the navel, passing through the anterior superior of the spina iliaca. Waist circumference <80 will be considered "low risk", >80-88 will be considered "high risk" and >88 will be considered "very high risk."
Measured: Change from before implementation, three and six months of practice.
Measurement and evaluation of blood pressure (BP)
By the Hypertension Diagnosis and Treatment Guidelines, measures will be made on both arms, and the average will be recorded. BP below 120/80 mmHg is normal, mean systolic BP of 120-139 mmHg and/or mean diastolic BP of 80-89 mmHg increased, and mean systolic BP ≥140 mmHg and/or mean diastolic BP ≥90 mmHg will be considered hypertension.
Measured: Change from before implementation, three and six months of practice.
Evaluation of fasting plasma glucose level
"Fasting plasma glucose" ≥ 126 mg/dl or "suspected diabetes mellitus" if values of "200 mg/dl" and above in a random measurement area will be evaluated as.
Measured: Change from before implementation and six months of practice.
Evaluation of glycosylated hemoglobin A1c (HbA1c) level
A1c 5.7-6.4% (39-47 mmol/mol) will be considered a "high-risk group." A1c ≥6.5% (≥48 mmol/mol) will be considered as "diabetes mellitus."
Measured: Change from before implementation and six months of practice.
Evaluation of blood lipid changes (Total cholesterol, HDL, LDL cholesterol, and triglyceride level)
Total cholesterol <200 mg/dL is considered "optimal," 200-239 mg/dL is "borderline high" and >240 mg/dL is "high". will be evaluated.
HDL cholesterol ≥60 mg/dL will be considered "optimal", 50-59 mg/dL will be considered "borderline high" and <50 mg/dL will be considered "high."
LDL cholesterol <100 mg/dL will be considered "optimal", 100-129 mg/dL will be considered "normal," 130-159 mg/dL will be considered "borderline high" and ≥160-189 mg/dL will be considered ''high,'' ≥190 mg/dL will be considered "very high."
A triglyceride of <150 mg/dL will be considered "normal,"150-199 mg/dL will be considered "borderline high," 200-500 mg/dL will be considered "high" and ≥500 mg/dL will be considered "very high."
Measured: Change from before implementation and six months of practice.
Body mass index (BMI) evaluation
BMI <18.5-24.9 kg/m2 will be defined as "normal", BMI between 25-29.9 kg/m2 will be defined as "overweight", and BMI≥ 30 kg/m2 will be defined as "obese".
Measured: Change from before implementation, three and six months of practice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start16 Oct 2023
- Primary completion24 Apr 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brief InterventionStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Guven, Mersin University
- Investigators
- Yasemin Güven, Master, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978323
- Sponsor's protocol ID
- MeU-YGUVEN-001
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brief Interventıon on Behavıoral Change, Anthropometrıc and Metabolıc Varıables In Overweıght Women wıth Low Health Lıteracy
- ClinicalTrials.gov ID
- NCT05978323
- Acronym / sponsor ID
- MeU-YGUVEN-001
- Conditions
- Brief Intervention
- Keywords
- Brief intervention, Overweight, Health literacy, Weight change, Metabolic variables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 7 Aug 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 will evaluate the effect of a brief intervention on anthropometric and metabolic changes in overweight women with low health literacy. The total number of samples was determined as 88. It was decided to recruit a total of 124 people, 62 people in each group, with a 40% loss in the groups. Brief intervention interviews will be conducted with the intervention group. Brief intervention interviews will take an average of 20-30 minutes and four times. The control group will not be intervened except for the first and last evaluations.
Detailed description
This study will evaluate the effect of a brief intervention on anthropometric and metabolic changes in overweight women with low health literacy. The total number of samples was determined as 88, 44 in each of the intervention and control groups. It was decided to recruit a total of 124 people, 62 people in each group, with a 40% loss in the groups. Randomization will be performed after obtaining consent from the participants who meet the eligibility and exclusion criteria. The sampled individuals will be assigned to the Intervention and Control groups according to the block randomization method. Brief intervention interviews will be conducted with the intervention group. It was determined as the first evaluation and the follow-ups on the 1st day, 15th day, 1st month, 3rd month, and the last evaluation (6th month). Brief interventions, 5A for those who are ready to change their behavior (Ask, Advise, Assess, Assist, Arrange); those who are not ready to change their behavior 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) model will be used. At the end of brief interventions applied to overweight women with low health literacy for 20-30 minutes, a total of four times; weight change, waist circumference change, blood pressure change, blood glucose change, blood lipid change, diet, and exercise behaviors will be evaluated. The control group will not be intervened except for the first and last evaluations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Brief intervention | Experimental | Behavioral: Brief interventionIntervention Group: Short face-to-face intervention interviews will be conducted with individuals in the intervention group. Interviews will be held in primary healthcare organizations' meeting rooms. Brief intervention interviews will be conducted with the intervention group. It was determined as the first evaluation and the follow-ups on the 1st day, 15th day, 1st month, 3rd month, and the last evaluation (6th month). Brief interventions, 5A for those who are ready to change their behavior (Ask, Advise, Assess, Assist, Arrange); Those who are not ready to change their behavior 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) model will be used. Brief intervention interviews will take an average of 20-30 minutes. The talks will include awareness of overweight and obesity, a healthy diet, and exercise. By the researcher's prepared will be used for individuals with low health literacy educational materials. |
| Control | No intervention | –The control group will not be intervened except for the first and last face-to-face evaluation. At the end of the research, training materials for weight loss will be given. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having heart disease, stroke, and chronic kidney failure diagnosed by a physician,
- Having diabetes that requires the use of insulin,
- Having hypothyroidism that prevents weight loss,
- Participating in a weight management program in the last 3 months,
- Being diagnosed with a disease that causes deterioration in cognitive processes such as Alzheimer's and dementia,
Key exclusion criteria (6 listed)
- Between 12.09.2023 and 24.06.2024 two Primary healthcare organization applied,
- Volunteered to participate in the research,
- Women between the ages of 30-65,
- The level of health literacy is limited-restricted,
- 25≥ BMI < 30,
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 |
|---|---|---|
| Brief interventionShort face-to-face intervention interviews will be conducted with individuals in the intervention group. Interviews will be held in primary healthcare organizations' meeting rooms. Brief intervention interviews will be conducted with the intervention group. It was determined as the first evaluation and the follow-ups on the 1st day, 15th day, 1st month, 3rd month, and the last evaluation (6th month). Brief interventions, 5A for those who are ready to change their behavior (Ask, Advise, Assess, Assist, Arrange); Those who are not ready to change their behavior 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) model will be used. Brief intervention interviews will take an average of 20-30 minutes. The talks will include awareness of overweight and obesity, a healthy diet, and exercise. By the researcher's prepared will be used for individuals with low health literacy educational materials. | Behavioural | Brief intervention |
Primary outcome
Evaluation of weight change
Time frame: Change from before implementation three and six months of practice.
The weight will be evaluated by measuring the weight.
9 secondary outcomes
The exercise habits will be evaluated using the Exercise Behavior Change Model Scales.
Time frame: Change from before implementation and six months of practice.
The eating habits will be evaluated using the Nutrition Processes of Change Scale.
Time frame: Change from before implementation and six months of practice.
The Mediterranean diet will be evaluated using the Mediterranean Diet Adherence Screener (MEDAS).
Time frame: Change from before implementation and six months of practice.
Waist circumference measurement and evaluation
Time frame: Change from before implementation, three and six months of practice.
Measurement and evaluation of blood pressure (BP)
Time frame: Change from before implementation, three and six months of practice.
Evaluation of fasting plasma glucose level
Time frame: Change from before implementation and six months of practice.
Evaluation of glycosylated hemoglobin A1c (HbA1c) level
Time frame: Change from before implementation and six months of practice.
Evaluation of blood lipid changes (Total cholesterol, HDL, LDL cholesterol, and triglyceride level)
Time frame: Change from before implementation and six months of practice.
Body mass index (BMI) evaluation
Time frame: Change from before implementation, three and six months of practice.
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 5 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
Yasemin Güven, Master principal investigator
Mersin 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 Brief intervention in people with Brief Intervention, run by Mersin 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 7 inclusion and 6 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 5 Aug 2025. 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?
Evaluation of weight change (time frame: Change from before implementation three and six months of practice.). 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 5 Aug 2025.