Clinical trial NCT05978323: The Effect of a Brief Intervention on Anthropometric and Metabolic Variables
Official title: The Effect of a Brief Intervention on Anthropometric and Metabolic Variables in Overweight Women With Low Health Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brief Intervention
Keywords: Brief intervention
Overweight
Health literacy
Weight change
Metabolic variables
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 124
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel randomized controlled clinical trial
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of weight change
timeFrame: Change from before implementation three and six months of practice.
Secondary outcomes:
measure: The exercise habits will be evaluated using the Exercise Behavior Change Model Scales.
timeFrame: Change from before implementation and six months of practice.
measure: The eating habits will be evaluated using the Nutrition Processes of Change Scale.
timeFrame: Change from before implementation and six months of practice.
measure: The Mediterranean diet will be evaluated using the Mediterranean Diet Adherence Screener (MEDAS).
timeFrame: Change from before implementation and six months of practice.
measure: Waist circumference measurement and evaluation
timeFrame: Change from before implementation, three and six months of practice.
measure: Measurement and evaluation of blood pressure (BP)
timeFrame: Change from before implementation, three and six months of practice.
measure: Evaluation of fasting plasma glucose level
timeFrame: Change from before implementation and six months of practice.
measure: Evaluation of glycosylated hemoglobin A1c (HbA1c) level
timeFrame: Change from before implementation and six months of practice.
measure: Evaluation of blood lipid changes (Total cholesterol, HDL, LDL cholesterol, and triglyceride level)
timeFrame: Change from before implementation and six months of practice.
measure: Body mass index (BMI) evaluation
timeFrame: Change from before implementation, three and six months of practice.
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Turkey, Mersin University
Study officials:
affiliation: Mersin University
name: Yasemin Güven, Master
role: PRINCIPAL_INVESTIGATOR
References: