The Effect of a Brief Intervention on Anthropometric and Metabolic Variables

Brief Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978323
• Other study ID #: MeU-YGUVEN-001
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: August 28, 2024

Study information

• Verified date: April 2024
• Source: Mersin University
• Contact: Yasemin Güven, Master
• Phone: +90 543 822 68 58
• Email: yaseminguven[@]mersin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: August 28, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brief Intervention

Intervention

Behavioral:
• Brief intervention
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.

Locations

Country	Name	City	State
Turkey	Turkey, Mersin University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of weight change	The weight will be evaluated by measuring the weight.	Change from before implementation three and six months of practice.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.