Effect of Nutritional Counseling on Health Outcomes in Obese Female Employees At Adam Malik Hospital
- Conditions
- Obesity
- Interventions
- Behavioral: Nutritional Counseling
- Registration Number
- NCT06621589
- Lead Sponsor
- RS H Adam Malik
- Brief Summary
The goal of this quasi-experimental study is to determine if nutritional counseling can improve health outcomes in obese female employees at Adam Malik Hospital in Medan. Specifically, the study aims to assess the impact of nutritional counseling on participants\' knowledge, attitudes, and health behaviors, as well as on various health indicators such as anthropometric measurements, body composition, lipid profile, uric acid levels, blood glucose, and HbA1c.
The main questions it aims to answer are:
* Does nutritional counseling lead to improved knowledge about nutrition among participants?
* How does nutritional counseling affect attitudes toward healthy eating and changes in health behaviors?
* What are the effects of nutritional counseling on anthropometric measurements, body composition, lipid profile, uric acid levels, blood glucose, and HbA1c?
Researchers will compare the health metrics of participants before and after receiving nutritional counseling to evaluate its effectiveness.
Participants will:
* Attend personalized nutritional counseling sessions over a period of 2 months.
* Complete assessments that include anthropometric measurements (weight, height, BMI), body composition analysis, and blood tests for lipid profile, uric acid levels, blood glucose, and HbA1c.
* Fill out questionnaires to provide information on their knowledge, attitudes, and health behaviors before and after the intervention.
This study aims to provide insights into the benefits of nutritional counseling in improving various health outcomes among obese female employees.
- Detailed Description
This quasi-experimental study is conducted over a period of two months and involves 150 obese female employees at Adam Malik Hospital, Medan. The primary aim is to evaluate the effectiveness of nutritional counseling in improving participants' knowledge, attitudes, and health behaviors related to obesity, as well as measuring key health indicators such as body composition, lipid profile, uric acid levels, blood glucose, and HbA1c.
The study design follows a pretest-posttest model with no control group. All participants undergo baseline measurements for anthropometric indicators (weight, height, and BMI), body composition analysis using bioelectrical impedance analysis (BIA), and blood tests for biochemical markers (lipid profile, uric acid, blood glucose, and HbA1c). Nutritional counseling is then provided in sessions where participant receives dietary guidance tailored to their specific needs and health goals.
Data collection also includes demographic information (age, profession, smoking status, alcohol consumption, comorbidities, dietary intake, marital and pregnancy history, socioeconomic status) to offer a broader context for analyzing the outcomes of the intervention. Participants are required to fast for at least 8 hours before blood samples are collected to ensure accurate biochemical assessments.
Upon completion of the counseling intervention, participants will undergo the same assessments as during the pretest phase. The study seeks to detect measurable changes in both behavioral and biological metrics, thereby providing insights into the efficacy of nutritional counseling as a tool for improving health outcomes in an obese working population.
This study also emphasizes the role of structured nutritional education in promoting long-term behavioral change, particularly in settings where employees may face challenges related to weight management. By addressing not only physical health indicators but also psychological factors like knowledge and attitudes, the study aims to contribute to a more holistic approach to workplace health management.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- Female employees at Adam Malik Hospital, Medan
- Participants aged <65 years
- Participants with a Body Mass Index (BMI) ≥25 kg/m²
- Participants who are willing to follow all stages of the research procedure and sign the informed consent
- Pregnant or breastfeeding women with infants under 1 year of age
- Participants undergoing routine treatment with insulin, corticosteroids, antipsychotics, antiepileptics, or beta-blockers
- Participants unable to undergo body composition measurement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nutritional Counseling Group Nutritional Counseling Participants in this arm will receive personalized nutritional counseling sessions aimed at improving their dietary habits, health knowledge, attitudes, and overall health outcomes. The counseling will take place over a 2-month period, and participants will undergo assessments before and after the intervention to evaluate changes in anthropometric measurements, body composition, and various health metrics.
- Primary Outcome Measures
Name Time Method Knowledge of Nutrition Counseling Baseline and 8 weeks after the intervention It will be assessed using a 10-item questionnaire. Participants will answer true or false statements related to nutrition. The questionnaire will be administered twice: before the intervention (baseline) and after the intervention. The score will reflect the number of correct responses, and the change in scores will be used to evaluate the effect of the nutritional counseling intervention.
Attitude in Nutritional Counseling Baseline and 8 weeks after the intervention It will be assessed using a questionnaire consisting of 20 statements. Participants will respond using a 6-point Likert scale ranging from strongly disagree to strongly agree. The change in attitude scores will be analyzed to determine the effectiveness of the counseling in shifting participants\' attitudes toward healthier eating and lifestyle habits.
Health behavior in Nutritional Counseling Baseline and 8 weeks after the intervention It will be assessed using the Transtheoretical Model (TTM) questionnaire, which consists of two parts: the stages of change and the processes of change. The stages of change section contains 6 statements, and participants select the one statement that best describes their current state. The processes of change section includes 32 items rated on a 5-point Likert scale, measuring participants\' engagement in behavioral change processes.
Weight in Nutritional Counseling Baseline and 8 weeks after the intervention Weight will be measured using a calibrated body weight scale. Participants will be assessed barefoot, standing upright, and with pockets emptied. Measurements will be recorded to an accuracy of 0.1 kg. Weight will be measured twice: before and after counseling to evaluate changes.
Outcome Measure: Weight (unit: kg)Height in Nutritional Counseling Baseline and 8 weeks after the intervention Height will be measured using a GEA SMIC ZT-120 scale stadiometer. Participants will be assessed barefoot, standing straight with their back, shoulders, buttocks, and heels against the wall. Measurements will be recorded to an accuracy of 0.1 cm. Height will be measured twice: before and after counseling to evaluate changes.
Outcome Measure: Height (unit: cm)Body Mass index in Nutritional Counseling Baseline and 8 weeks after the intervention Body Mass Index (BMI) will be calculated using the formula BMI = weight (kg) / height (m²). Weight will be measured using a calibrated body weight scale and height using a GEA SMIC ZT-120 scale stadiometer. BMI will be calculated after obtaining both measurements, assessed twice: before and after counseling to evaluate changes.
Outcome Measure: BMI (unit: kg/m²)Fat Mass Index in Nutritional Counseling Baseline and 8 weeks after the intervention Fat Mass Index (FMI) will be calculated using the formula FMI = fat mass (kg) / height (m²). Fat mass will be measured using a bioelectrical impedance analysis (BIA) device, SECA 514. Participants will follow standard preparation guidelines. FMI will be assessed before and after counseling to evaluate changes.
Outcome Measure: Fat Mass Index (unit: kg/m²)Fat Free Mass Index in Nutritional Counseling Baseline and 8 weeks after the intervention Fat Free Mass Index (FFMI) will be calculated using the formula FFMI = fat free mass (kg) / height (m²). Fat free mass will be assessed using the bioelectrical impedance analysis (BIA) device, SECA 514. Participants will be prepared as per standard guidelines. FFMI will be measured before and after counseling to track changes.
Outcome Measure: Fat Free Mass Index (unit: kg/m²)Skeletal Muscle Mass in Nutritional Counseling Baseline and 8 weeks after the intervention Skeletal Muscle Mass (SMM) will be measured using the bioelectrical impedance analysis (BIA) device, SECA 514. Participants will adhere to standard preparation procedures. SMM will be recorded in kilograms (kg) and assessed before and after counseling to monitor changes.
Outcome Measure: Skeletal Muscle Mass (unit: kg)
- Secondary Outcome Measures
Name Time Method Lipid Profile in Nutritional Counseling Baseline and 8 weeks after the intervention This measure evaluates the effect of nutritional counseling on the lipid profile, including total cholesterol, LDL, HDL, and triglycerides. Participants will undergo venous blood sampling after fasting for at least 8 hours. The blood samples will be analyzed in a certified laboratory to determine lipid profile levels.
Uric Acid Levels in Nutritional Counseling Baseline and 8 weeks after the intervention Venous blood samples will be collected after a minimum of 8 hours of fasting. The samples will be processed in a standardized laboratory to obtain the uric acid concentrations. The differences between pre- and post-intervention levels will be analyzed to determine the effect of the counseling on uric acid metabolism.
Blood Glucose Levels in Nutritional Counseling Baseline and 8 weeks after the intervention Blood samples will be drawn from the peripheral veins after at least 8 hours of fasting. The samples will be analyzed in a certified laboratory to measure fasting blood glucose. Pre- and post-intervention values will be compared to evaluate the impact on glycemic control.
HbA1c in Nutritional Counseling Baseline and 8 weeks after the intervention This measure evaluates the effect of nutritional counseling on HbA1c levels, a key marker for long-term blood glucose regulation. Venous blood samples will be collected after at least 8 hours of fasting and analyzed in a certified laboratory to measure HbA1c levels. The comparison of HbA1c values before and after the intervention will provide insights into its impact on long-term glycemic control.
Trial Locations
- Locations (1)
Nutrition Unit of Adam Malik Hospital
🇮🇩Medan, North Sumatera, Indonesia