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

Mersin University

Status: Completed

Conditions: Brief Intervention

Treatments: Behavioral: Brief intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05978323

MeU-YGUVEN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Brief intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Brief intervention

Control

No Intervention group

Description:

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.