Clinical trial NCT06621589: Effect of Nutritional Counseling on Health Outcomes in Female Workers Wih Obesity at Adam Malik Hospital
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Nutritional Counseling
Obesity
Female Employees
Anthropometry
Body Composition
Lipid Profile
Uric Acid Levels
Blood Glucose
HbA1c
Quasi-Eksperimental Study
Adam Malik Hospital
Medan
Dietary Intervention
Lead sponsor: RS H Adam Malik
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 97
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a quasi-experimental design with a single group of participants receiving nutritional counseling. The participants will undergo pre- and post-intervention assessments to measure changes in health indicators, attitudes, and behaviors.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Height in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Body Mass index in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Mid-Upper Arm Circumference (MUAC) in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Waist Circumference (WC) in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Fat Free Mass Index in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Fat Mass in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Skeletal Muscle Mass in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Visceral Adipose Tissue (VAT) in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Uric Acid Levels in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Blood Glucose Levels in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
measure: Total Cholesterol in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
Secondary outcomes:
measure: Attitude in Nutritional Counseling
timeFrame: Baseline and 8 weeks after the intervention
measure: Behavioral Changes in Nutritional Counseling
timeFrame: Baseline and 8-week after the intervention
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: Nutrition Unit of Adam Malik Hospital
state: North Sumatera
Study officials:
affiliation: Indonesian Association of Clinical Nutrition Specialists
name: Hilna K Shalihat, Master's
role: PRINCIPAL_INVESTIGATOR
References: