The Effect of a Brief Intervention on Anthropometric and Metabolic Variables

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of a Brief Intervention on Anthropometric and Metabolic Variables in Overweight Women With Low Health Literacy

Conditions
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Brief Intervention

Intervention / Treatment
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* Behavioral: Brief intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel randomized controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief intervention<br>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. | Behavioral: Brief intervention<br>* 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.<br>|
| No Intervention: Control<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of weight change | The weight will be evaluated by measuring the weight. | Change from before implementation three and six months of practice. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from before implementation, three and six months of practice. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brief intervention, Overweight, Health literacy, Weight change, Metabolic variables