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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2024-10-09

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.

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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.

Conditions

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Brief Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel randomized controlled clinical trial

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

For each group, 21 blocks were created by generating random numbers in Excel by a person other than the researcher and assigned to groups A and B. The assignment of the intervention and control groups was made by drawing lots. Index cards prepared for two primary healthcare organizations by block randomization by the researcher who did not participate in the clinical part of the study will be placed in closed opaque envelopes and their sequence numbers will be written on the envelopes. The research data will be entered into the computer database by the researcher as coded as A and B. Statistical analyses will be performed by the researcher who did not participate in the data collection phase according to this code. The research report will also be written in coded form. Research participants and statistical evaluators were planned to be blind to group assignment, single-blind, and statistician blind.

Study Groups

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Brief intervention

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.

Group Type EXPERIMENTAL

Brief intervention

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes