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

NCT05978323 | Completed DMC

• 1 other identifier: MeU-YGUVEN-001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brief Intervention

Keywords

Brief intervention; Overweight; Health literacy; Weight change; Metabolic variables

Outcome Measures

Primary Outcomes (1)

• Evaluation of weight change

  The weight will be evaluated by measuring the weight.

  Change from before implementation three and six months of practice.

Secondary Outcomes (9)

• The exercise habits will be evaluated using the Exercise Behavior Change Model Scales.

  Change from before implementation and six months of practice.

• The eating habits will be evaluated using the Nutrition Processes of Change Scale.

  Change from before implementation and six months of practice.

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

  Change from before implementation and six months of practice.

• Waist circumference measurement and evaluation

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

• Measurement and evaluation of blood pressure (BP)

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

Study Arms (2)

Brief intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Brief intervention

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,
• ≥ BMI \< 30,
• Those who can read and understand Turkish will be included in the study.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Turkey, Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Overweight; Body Weight Changes

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yasemin Güven, Master

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Prospective, parallel randomized controlled clinical trial

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: August 7, 2023
• Study Start: October 16, 2023
• Primary Completion: April 24, 2024
• Study Completion: October 9, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1)