Skip to main content
OpenTrials
Completed

NCT Number: NCT05978323

The Effect of a Brief Intervention on Behavıoral Change, Anthropometric and Metabolic Variables

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brief Intervention Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Turkey, Mersin University

Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 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.

  2. 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 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.

  3. The Mediterranean diet will be evaluated using the Mediterranean Diet Adherence Screener (MEDAS).

    Time frame: Change from before implementation and six months of practice.

    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.

  4. Waist circumference measurement and evaluation

    Time frame: Change from before implementation, three and six months of practice.

    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."

  5. Measurement and evaluation of blood pressure (BP)

    Time frame: Change from before implementation, three and six months of practice.

    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.

  6. Evaluation of fasting plasma glucose level

    Time frame: Change from before implementation and six months of practice.

    "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.

  7. Evaluation of glycosylated hemoglobin A1c (HbA1c) level

    Time frame: Change from before implementation and six months of practice.

    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."

  8. Evaluation of blood lipid changes (Total cholesterol, HDL, LDL cholesterol, and triglyceride level)

    Time frame: Change from before implementation and six months of practice.

    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."

  9. Body mass index (BMI) evaluation

    Time frame: Change from before implementation, three and six months of practice.

    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".

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

The Effect of Brief Interventıon on Behavıoral Change, Anthropometrıc and Metabolıc Varıables In Overweıght Women wıth Low Health Lıteracy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.