ObesityECHO-OFEMNCT06621589
Effect of Nutritional Counseling on Health Outcomes in Female Workers Wih Obesity at Adam Malik Hospital
A study testing Nutritional Counseling in people with Obesity, run by RS H Adam Malik at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 63 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Nutritional Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Aug 2024to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 63 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Nutrition Unit of Adam Malik Hospital
Medan, North Sumatera, 20136
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Nutritional Counseling
- 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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Counseling Group | Experimental | 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. Receives: Behavioral: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline and 8-week after the intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 8-week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start26 Aug 2024
- Primary completion25 Oct 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- RS H Adam Malik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilna Khairunisa Shalihat, RS H Adam Malik
- Investigators
- Hilna K Shalihat, Master's, Principal investigator, Indonesian Association of Clinical Nutrition Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621589
- Sponsor's protocol ID
- 1084/KEPK/USU/2024
- Acronym
- ECHO-OFEM
- Status last verified
- Jun 2025
- First submitted
- 19 Sep 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06621589
- Acronym / sponsor ID
- ECHO-OFEM / 1084/KEPK/USU/2024
- Conditions
- Obesity
- Keywords
- Nutritional Counseling, Obesity, Female Employees, Anthropometry, Body Composition, Lipid Profile, Uric Acid Levels, Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- RS H Adam MalikUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutritional Counseling Group | Experimental | Behavioral: Nutritional CounselingParticipants 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. |
Who may qualify
- Ages
- 24 to 63 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional CounselingThe 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 | Behavioural | Nutritional Counseling Group |
Primary outcome
Weight in Nutritional Counseling
Time frame: Baseline and 8-week 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
Time frame: Baseline and 8-week 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
Time frame: Baseline and 8-week 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)
Mid-Upper Arm Circumference (MUAC) in Nutritional Counseling
Time frame: Baseline and 8-week after the intervention
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.
Waist Circumference (WC) in Nutritional Counseling
Time frame: Baseline and 8-week after the intervention
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.
Fat Free Mass Index in Nutritional Counseling
Time frame: Baseline and 8-week 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)
Fat Mass in Nutritional Counseling
Time frame: Baseline and 8-week after the intervention
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.
Skeletal Muscle Mass in Nutritional Counseling
Time frame: Baseline and 8-week 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)
Visceral Adipose Tissue (VAT) in Nutritional Counseling
Time frame: Baseline and 8-week after the intervention
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.
Uric Acid Levels in Nutritional Counseling
Time frame: Baseline and 8-week after the intervention
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)
Blood Glucose Levels in Nutritional Counseling
Time frame: Baseline and 8-week after the intervention
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.
Total Cholesterol in Nutritional Counseling
Time frame: Baseline and 8-week after the intervention
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.
2 secondary outcomes
Attitude in Nutritional Counseling
Time frame: Baseline and 8 weeks after the intervention
Behavioral Changes in Nutritional Counseling
Time frame: Baseline and 8-week after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilna K Shalihat, Master's principal investigator
Indonesian Association of Clinical Nutrition Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Counseling in people with Obesity, run by RS H Adam Malik at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight in Nutritional Counseling (time frame: Baseline and 8-week after the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.