Effect of Nutritional Counseling on Health Outcomes in Female Workers Wih Obesity at Adam Malik Hospital (ECHO-OFEM)

The Effect of Nutritional Counseling on Anthropometry, Body Composition, Total Cholesterol, Blood Glucose, Uric Acid Levels, Attitude, and Behavior in Female Workers Wih Obesity at Adam Malik Hospital, Indonesia

The goal of this quasi-experimental study is to determine whether nutritional counseling can improve health outcomes in female workers with obesity at Adam Malik Hospital in Medan. Specifically, the study aims to assess the impact of nutritional counseling on participants; anthropometric measurements, body composition, total cholesterol, blood glucose, uric acid levels, as well as on attitudes, and behavioral changes.

The main questions it aims to answer are:

• What are the effects of nutritional counseling on anthropometric measurements, body composition, total cholesterol, blood glucose, uric acid levels?
• How does nutritional counseling affect attitudes toward healthy eating and changes in health behaviors?

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 total cholesterol, blood glucose, uric acid levels
• Fill out questionnaires to provide information on their 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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Nutritional Counseling

Detailed Description

This quasi-experimental study is conducted over a period of two months and involves 97 obese female employees at Adam Malik Hospital, Medan. The primary aim is to evaluate the effectiveness of nutritional counseling in improving participants' anthropometric measurements, body composition, total cholesterol, blood glucose, uric acid levels, as well as on attitudes, and behavioral changes.

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 ( total cholesterol, blood glucose, uric acid levels). 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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • North Sumatera
    • Medan, North Sumatera, Indonesia, 20136
      • Nutrition Unit of Adam Malik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Nutritional Counseling Group; Participants in this arm will receive personalized nutritional counseling sessions aimed at improving their dietary habits, attitudes, and overall health outcomes. The counseling will take place over a 8-week period, and participants will undergo assessments before and after the intervention to evaluate changes in anthropometric measurements, body composition, and various health metrics.

Behavioral: Nutritional Counseling; The intervention involves nutritional counseling aimed at improving dietary habits and overall health to participants. During the 2-month period, participants will receive guidance on nutrition, diet planning, and lifestyle changes tailored to their needs. Assessments of knowledge, attitudes, and health metrics will be conducted before and after the counseling sessions to measure the effectiveness of the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in Nutritional Counseling	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)	Baseline and 8-week after the intervention
Height in Nutritional Counseling	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)	Baseline and 8-week after the intervention
Body Mass index in Nutritional Counseling	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)	Baseline and 8-week after the intervention
Mid-Upper Arm Circumference (MUAC) in Nutritional Counseling	Mid-Upper Arm Circumference (MUAC) will be measured using the SECA 201 measuring tape. Measurements will be taken at the midpoint between the acromion and olecranon processes of the non-dominant arm, following standard procedures. MUAC will be recorded before and after the nutritional counseling intervention to assess changes in muscle and fat tissue.	Baseline and 8-week after the intervention
Waist Circumference (WC) in Nutritional Counseling	Waist Circumference (WC) will be measured using the SECA 201 measuring tape at the midpoint between the lowest rib and the iliac crest, following standard anthropometric guidelines. WC measurements will be taken before and after the nutritional counseling intervention to monitor changes in abdominal fat.	Baseline and 8-week after the intervention
Fat Free Mass Index in Nutritional Counseling	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)	Baseline and 8-week after the intervention
Fat Mass in Nutritional Counseling	Fat Mass will be calculated using the bioelectrical impedance analysis (BIA) device, SECA 514. Participants will be prepared according to standard guidelines prior to measurement. Fat Mass (in kilograms) will be assessed before and after the nutritional counseling intervention to monitor changes in body composition.	Baseline and 8-week after the intervention
Skeletal Muscle Mass in Nutritional Counseling	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)	Baseline and 8-week after the intervention
Visceral Adipose Tissue (VAT) in Nutritional Counseling	Visceral Adipose Tissue (VAT) will be measured using the bioelectrical impedance analysis (BIA) device, SECA 514. Participants will follow standard preparation guidelines before the assessment. VAT will be evaluated before and after the nutritional counseling intervention to monitor changes in visceral fat levels.	Baseline and 8-week after the intervention
Uric Acid Levels in Nutritional Counseling	Uric acid levels will be measured using the AutoCheck device, a point-of-care testing system. Blood samples will be collected via finger prick without the need for fasting. Measurements will be taken at baseline and 8 weeks after the nutritional counseling intervention to monitor changes in uric acid levels. Outcome Measure: Uric Acid (unit: mg/dL or μmol/L)	Baseline and 8-week after the intervention
Blood Glucose Levels in Nutritional Counseling	Blood glucose levels will be measured using the AutoCheck device, a point-of-care testing system. Blood samples will be collected via finger prick after an overnight fast of at least 8 hours. Measurements will be taken at baseline and 8 weeks after the nutritional counseling intervention to monitor changes in glycemic control.	Baseline and 8-week after the intervention
Total Cholesterol in Nutritional Counseling	Total cholesterol levels will be measured using the AutoCheck device, a point-of-care testing system. Blood samples will be collected via finger prick after an overnight fast of at least 8 hours. Measurements will be conducted at baseline and 8 weeks after the nutritional counseling intervention to monitor changes in lipid profile.	Baseline and 8-week after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitude in Nutritional Counseling	Attitude will be assessed using a questionnaire adapted from the Weight Self-Stigma Questionnaire (WSSQ) consisting of 12 statements. Participants will respond using a 6-point Likert scale ranging from strongly disagree to strongly agree. Changes in attitude scores will be analyzed to evaluate the effectiveness of the nutritional counseling in modifying participants' attitudes toward weight and eating behaviors.	Baseline and 8 weeks after the intervention
Behavioral Changes in Nutritional Counseling	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.	Baseline and 8-week after the intervention

Collaborators and Investigators

• Sponsor: RS H Adam Malik
• Investigators: Principal Investigator: Hilna K Shalihat, Master's, Indonesian Association of Clinical Nutrition Specialists

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; HbA1c; Body Composition; Blood Glucose; Dietary Intervention; Anthropometry; Lipid Profile; Nutritional Counseling; Female Employees; Uric Acid Levels; Quasi-Eksperimental Study; Adam Malik Hospital; Medan
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 1084/KEPK/USU/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) will not be shared due to concerns regarding participant confidentiality and lack of appropriate infrastructure to ensure secure data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No