Dietary HabitsNCT04085874
Effectiveness of Food-Based Recommendations for Minangkabau Women of Reproductive Age With Dyslipidemia
A study testing Promotion of Food-based recommendations and Nutrition counseling from standard health services care in people with Dietary Habits and Nutrient Deficiency, run by Politeknik Kesehatan Kemenkes Padang at 1 site in Indonesia.
Trial summary
This study aimed to assess effectiveness of promoting the optimized Food-based recommendations (FBRs) for improving dietary practices, nutrient intakes, nutritional status and lipid profile among Minangkabau women of reproductive age with dyslipidemia in a community setting. Read more about this study
- Who is it for?
- Ages 20 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Nutrient Deficiency, Obesity
- What is being tested?
- Promotion of Food-based recommendations and Nutrition counseling from standard health services care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Jan 2019to 10 Jun 2019
- 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 20 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women of reproductive age (20-44 years);
- native Minangkabau ethnic (both father and mother from the Minangkabau tribe);
- had abnormal one of isolated blood lipid profiles (cholesterol > 200 mg / dl, LDL-cholesterol >100 mg / dl, HDL < 60 mg/dl, TG > 150 mg/dl);
- signing a written inform consent.
Who cannot join
- in pregnancy;
- having a history or active smoker and alcoholic addict;
- has a history of heart disease, diabetes, asthma, cancer, chronic digestive tract disorders, hemophilia and other chronic diseases;
- routinely taking cholesterol-lowering or blood pressure medications;
- vegetarians;
- use estrogen therapy;
- are participating in other studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Optimized Food-Based Recommendations to Improve Dietary Practice, Intake of Problem Nutrient, Nutritional Status and Lipid Profile Among Minangkabau Women of Reproductive Age With Dyslipidemia
This study aimed to assess effectiveness of promoting the optimized Food-based recommendations (FBRs) for improving dietary practices, nutrient intakes, nutritional status and lipid profile among Minangkabau women of reproductive age with dyslipidemia in a community setting. A cluster randomized community-based trial was conducted in Padang City, West Sumatra, Indonesia. Subjects are Minagabau women of reproductive age (20-44 y) with dyslipidemia. The subjects were assigned either into FBR group (n=48) that involved in 12-weeks prolonged contact of FBRs promotion or into non-FBR group, that received once nutrition counselling from usual standard of nutrition program. Baseline and end-line lipid profiles, nutritional status, dietary practice and nutrient intake data were assessed through biochemical assessment, anthropometri, and interview structured questionaire.
Read the detailed description
This study was conducted in two sequential phases. The first stage was a formative phase in the form of observational survey to develop and validate food-based recommendations (FBRs). The second phase was an intervention study to assess the effectiveness of the FBRs in improving dietary practice, the intake of problem nutrient, nutritional status and lipid profile of the subject.
Sample size for intervention per group (n=60/group; 2 groups) was expected to detect mean(±SD) differences in LDL-cholesterol concentration (as an secondary outcome) of 14±20 mg/dL as observed in a previous study in other area, with assumption of 80% power and 25% loss of follow up. Potential subjects were identified prior to dyslipidemia screening before intervention. Field nutritionist and volunteer cadres were requested to identify and list women of reproductive age fulfilling the inclusion criteria living in selected sites. An invitation letter was sent to all identified eligible subjects to visit appointed field laboratory to perform blood measurement. Inform consent was signed by all potential participants before blood measurement.
This study did not compare an intervention group (FBR group) with a true control group, but with a comparison group that received once nutrition counselling from usual nutrition health program (non-FBR group). Drawing on concepts of Plan Behavior Theory, persuasive FBR promotion was designed to influence subjects' attitude, subjective norms, perceive behavior control related to dyslipidemia and dietary management, and intention to change. Participants were prompted to set goals for themselves to improve their dietary practices in order to fulfill their nutrient requirements, improve nutritional status and lipid profile.
- Conditions
- Dietary Habits, Nutrient Deficiency, Obesity, Dyslipidemias
- Being tested
- Promotion of Food-based recommendations, Nutrition counseling from standard health services care
- Keywords
- Nutrition intervention, Food-Based Recommendations, dietary practices, women of reproductive age, dyslipidemia
- Medical subject headings
- Feeding Behavior, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of Food-based recommendationsBehavioural
Also called Nutrition education
Prolonged contact through weekly home visits and monthly group meeting for 12 weeks
Nutrition counseling from standard health services careBehavioural
Also called Standard nutrition care
once nutrition counselling from health services
| Study group | Role | What they receive |
|---|---|---|
| FBR group | Experimental | weekly home visit and monthly group meeting for 12 weeks Receives: Behavioral: Promotion of Food-based recommendations |
| non-FBR group | Active comparator | once nutrition counseling from standard health care services Receives: Behavioral: Nutrition counseling from standard health services care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dietary practice
Change in food consumption from baseline at 12-week intervention, evaluated based on participant's compliance to the Optimized Food-Based Recommendations. The compliance were measured using one-week Food Frequency Questionnaire (FFQ), stated in servings/week for staple foods. snacks, animal protein (sea fish, eggs, poultry), soy protein (tofu/tempeh), potato, fruits,dark green vegetables (DGLV), total vegetables and fried foods. The recommendations (servings/week) for those food groups/items was 14-21, 7-14, minimum 5, 3-4, 2-3,minimum 7,minimum 5, minimum 7, minimum 5, minimum 14, and maximum 14 respectively. Those who complied with the recommendations was scored 1 for each recommendations, and 0 for those who did not. The total score for the compliance to the FBRs was 0-11. Higher score represents better participant's compliance
Measured: baseline (before the intervention) and end-line (after 12-weeks intervention)
Change in energy intake
Change from baseline at 12-week intervention for energy intake( in Kcal). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in protein intake
Change from baseline at 12-week intervention for protein intake( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in total fat intake
Change from baseline at 12-week intervention for total fat intake( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in carbohydrate intake
Change from baseline at 12-week intervention for carbohydrate intake ( in gram)
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in poly unsaturated fatty acids (PUFA) intake
Change from baseline at 12-week intervention for PUFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in mono unsaturated fatty acids (MUFA) intakes
Change from baseline at 12-week intervention for MUFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in saturated fatty acids (SFA) intakes
Change from baseline at 12-week intervention for SFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in PUFA/SFA (P/S) ratio
Change from baseline at 12-week intervention for P/S
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in dietary fiber intakes
Change from baseline at 12-week intervention for dietary fiber intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in iron (Fe) intake
Change from baseline at 12-week intervention for iron intake ( in mg). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in zinc (Zn) intake
Change from baseline at 12-week intervention for zinc intake ( in mg). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Secondary outcomes (6)
Change in Body weight
Change in Body weight (in Kg) from baseline at 12-week intervention
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in waist circumference
change of waist circumference (in cm), from baseline at 12-week intervention
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in total cholesterol level
Change of total cholesterol (in mg/dL) from baseline at 12-week intervention
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in Low Desnsity Lipoprotein (LDL) cholesterol
Change of LDL (in mg/dL) from baseline at 12-week intervention
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in serum High Density Lipoprotein (HDL) cholesterol
Change of HDL (mg/dL) from baseline at 12-week intervention
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Change in serum triglyceride (TG)
Change of TG (mg/dL) from baseline at 12-week intervention
Measured: baseline (before intervention and end-line (after 12-weeks interventions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start7 Jan 2019
- Primary completion5 May 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Politeknik Kesehatan Kemenkes Padang
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia
- Responsible party
- Principal investigator, Gusnedi, Politeknik Kesehatan Kemenkes Padang
- Investigators
- Murdani Abdullah, Study chair, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085874
- Sponsor's protocol ID
- 18-12-1376
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gusnedi G, Fahmida U, Witjaksono F, Nurwidya F, Mansyur M, Djuwita R, Dwiriani CM, Abdullah M. Effectiveness of optimized food-based recommendation promotion to improve nutritional status and lipid profiles among Minangkabau women with dyslipidemia: A cluster-randomized trial. BMC Public Health. 2022 Jan 6;22(1):21. doi: 10.1186/s12889-021-12462-5.
PubMed 34991541
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Optimized Food-Based Recommendations to Improve Dietary Practice, Intake of Problem Nutrient, Nutritional Status and Lipid Profile Among Minangkabau Women of Reproductive Age With Dyslipidemia
- ClinicalTrials.gov ID
- NCT04085874
- Acronym / sponsor ID
- 18-12-1376
- Conditions
- Dietary Habits, Nutrient Deficiency, Obesity, Dyslipidemias
- Keywords
- Nutrition intervention, Food-Based Recommendations, dietary practices, women of reproductive age, dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Politeknik Kesehatan Kemenkes PadangUniversity, hospital or other
- Collaborators
- Universitas Indonesia
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 11 Sep 2019 (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.
This study aimed to assess effectiveness of promoting the optimized Food-based recommendations (FBRs) for improving dietary practices, nutrient intakes, nutritional status and lipid profile among Minangkabau women of reproductive age with dyslipidemia in a community setting. A cluster randomized community-based trial was conducted in Padang City, West Sumatra, Indonesia. Subjects are Minagabau women of reproductive age (20-44 y) with dyslipidemia. The subjects were assigned either into FBR group (n=48) that involved in 12-weeks prolonged contact of FBRs promotion or into non-FBR group, that received once nutrition counselling from usual standard of nutrition program. Baseline and end-line lipid profiles, nutritional status, dietary practice and nutrient intake data were assessed through biochemical assessment, anthropometri, and interview structured questionaire.
Detailed description
This study was conducted in two sequential phases. The first stage was a formative phase in the form of observational survey to develop and validate food-based recommendations (FBRs). The second phase was an intervention study to assess the effectiveness of the FBRs in improving dietary practice, the intake of problem nutrient, nutritional status and lipid profile of the subject.
Sample size for intervention per group (n=60/group; 2 groups) was expected to detect mean(±SD) differences in LDL-cholesterol concentration (as an secondary outcome) of 14±20 mg/dL as observed in a previous study in other area, with assumption of 80% power and 25% loss of follow up. Potential subjects were identified prior to dyslipidemia screening before intervention. Field nutritionist and volunteer cadres were requested to identify and list women of reproductive age fulfilling the inclusion criteria living in selected sites. An invitation letter was sent to all identified eligible subjects to visit appointed field laboratory to perform blood measurement. Inform consent was signed by all potential participants before blood measurement.
This study did not compare an intervention group (FBR group) with a true control group, but with a comparison group that received once nutrition counselling from usual nutrition health program (non-FBR group). Drawing on concepts of Plan Behavior Theory, persuasive FBR promotion was designed to influence subjects' attitude, subjective norms, perceive behavior control related to dyslipidemia and dietary management, and intention to change. Participants were prompted to set goals for themselves to improve their dietary practices in order to fulfill their nutrient requirements, improve nutritional status and lipid profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBR group | Experimental | Behavioral: Promotion of Food-based recommendationsweekly home visit and monthly group meeting for 12 weeks |
| non-FBR group | Active comparator | Behavioral: Nutrition counseling from standard health services careonce nutrition counseling from standard health care services |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women of reproductive age (20-44 years);
- native Minangkabau ethnic (both father and mother from the Minangkabau tribe);
- had abnormal one of isolated blood lipid profiles (cholesterol > 200 mg / dl, LDL-cholesterol >100 mg / dl, HDL < 60 mg/dl, TG > 150 mg/dl);
- signing a written inform consent.
Key exclusion criteria (7 listed)
- in pregnancy;
- having a history or active smoker and alcoholic addict;
- has a history of heart disease, diabetes, asthma, cancer, chronic digestive tract disorders, hemophilia and other chronic diseases;
- routinely taking cholesterol-lowering or blood pressure medications;
- vegetarians;
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 |
|---|---|---|
| Promotion of Food-based recommendationsAlso: Nutrition educationProlonged contact through weekly home visits and monthly group meeting for 12 weeks | Behavioural | FBR group |
| Nutrition counseling from standard health services careAlso: Standard nutrition careonce nutrition counselling from health services | Behavioural | non-FBR group |
Primary outcome
Change in Dietary practice
Time frame: baseline (before the intervention) and end-line (after 12-weeks intervention)
Change in food consumption from baseline at 12-week intervention, evaluated based on participant's compliance to the Optimized Food-Based Recommendations. The compliance were measured using one-week Food Frequency Questionnaire (FFQ), stated in servings/week for staple foods. snacks, animal protein (sea fish, eggs, poultry), soy protein (tofu/tempeh), potato, fruits,dark green vegetables (DGLV), total vegetables and fried foods. The recommendations (servings/week) for those food groups/items was 14-21, 7-14, minimum 5, 3-4, 2-3,minimum 7,minimum 5, minimum 7, minimum 5, minimum 14, and maximum 14 respectively. Those who complied with the recommendations was scored 1 for each recommendations, and 0 for those who did not. The total score for the compliance to the FBRs was 0-11. Higher score represents better participant's compliance
Change in energy intake
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for energy intake( in Kcal). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software
Change in protein intake
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for protein intake( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software
Change in total fat intake
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for total fat intake( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Change in carbohydrate intake
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for carbohydrate intake ( in gram)
Change in poly unsaturated fatty acids (PUFA) intake
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for PUFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Change in mono unsaturated fatty acids (MUFA) intakes
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for MUFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Change in saturated fatty acids (SFA) intakes
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for SFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Change in PUFA/SFA (P/S) ratio
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for P/S
Change in dietary fiber intakes
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for dietary fiber intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Change in iron (Fe) intake
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for iron intake ( in mg). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
Change in zinc (Zn) intake
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for zinc intake ( in mg). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.
6 secondary outcomes
Change in Body weight
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change in waist circumference
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change in total cholesterol level
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change in Low Desnsity Lipoprotein (LDL) cholesterol
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change in serum High Density Lipoprotein (HDL) cholesterol
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change in serum triglyceride (TG)
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
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 11 Sep 2019.
- Derived from this study: PubMed 34991541Gusnedi G, Fahmida U, Witjaksono F, Nurwidya F, Mansyur M, Djuwita R, Dwiriani CM, Abdullah M. Effectiveness of optimized food-based recommendation promotion to improve nutritional status and lipid profiles among Minangkabau women with dyslipidemia: A cluster-randomized trial. BMC Public Health. 2022 Jan 6;22(1):21. doi: 10.1186/s12889-021-12462-5.
- Individual participant dataSharing planned: No
Related trials for Dietary Habits
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
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.
Murdani Abdullah study chair
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of Food-based recommendations and Nutrition counseling from standard health services care in people with Dietary Habits and Nutrient Deficiency, run by Politeknik Kesehatan Kemenkes Padang 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 7 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 11 Sep 2019. 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?
Change in Dietary practice (time frame: baseline (before the intervention) and end-line (after 12-weeks 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?
On the ClinicalTrials.gov record for NCT04085874, which also lists 1 linked publication.
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 11 Sep 2019.