ObesityNCT03469869
Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People
A study testing balanced and sustainable diet in people with Obesity and Insulin Resistance, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study evaluates the effect of balanced and sustainable diet application on fat composition, insulin resistance and inflammation marker in obese people. Intervention: Obese subject will receive intervention on balanced and sustainable diet application Control: Obese subject will receive a balanced diet application… Read more about this study
- Who is it for?
- Ages 19 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Inflammation
- What is being tested?
- balanced and sustainable diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Mar 2018to 31 Oct 2018
- 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 19 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index ≥ 25 kg/m2
- using Android-based smartphone
- willing to join this research by signing informed consent
Who cannot join
- pale in physical examination
- in weight loss program
- have obesity with comorbidities
- have hormonal diseases
- consumed hormonal drug, PTU, anti diabetes drug
- smoking or stop smoking under 2 years
- pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia
This study evaluates the effect of balanced and sustainable diet application on fat composition, insulin resistance and inflammation marker in obese people.
Intervention: Obese subject will receive intervention on balanced and sustainable diet application Control: Obese subject will receive a balanced diet application only
Read the detailed description
Maintaining the adherence of weight loss programme while selecting healthy and sustainable foods will become a worldwide future challenge in nutrition. Therefore, we investigated the suitable content, graphic, and flow in developing a mobile application as an alternative solution for enhancing the compliance of weight control and selecting healthy food with the least environmental impact.
The treatment for obesity consists of dieting, physical exercise, pharmacology, and surgery. Restricted balanced diet is a well known diet recommendation for people with obesity. Sustainable diet is an alternative form of diet which contributes to healthy life and is protective of biodiversity.
The main challenge in obesity management is the sustainability of weight loss programme. Mobile apps are an alternative solution for enhancing compliance.
- Conditions
- Obesity, Insulin Resistance, Inflammation, Blood Glucose, High
- Being tested
- balanced and sustainable diet
- Keywords
- Obesity
- Medical subject headings
- Obesity, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balanced and sustainable dietOther
the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.
the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.
| Study group | Role | What they receive |
|---|---|---|
| balanced and sustainable diet | Experimental | The intervention group will receive menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the control group will receive menu recommendation of balanced diet for 8 weeks. these menus are given in the apps Receives: Other: balanced and sustainable diet |
| balanced diet | Active comparator | the intervention group receive get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will receive menu recommendation of balanced diet for 8 weeks. these menus are given in the apps Receives: Other: balanced and sustainable diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body weight
Change from baseline body weight at 8 weeks, is measured in kg
Measured: baseline at Day0 and endline at Day56
Secondary outcomes (9)
Change of Fat Mass
Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg
Measured: baseline at Day0 and endline at Day56
Change of Fasting plasma glucose
Change from baseline Fasting plasma glucose at 8 weeks, is measured in mg/dL
Measured: baseline at Day0 and endline at Day56
Change of TNF alpha
Change from baseline TNF alpha at 8 weeks, is measured in pg/ml
Measured: baseline at Day0 and endline at Day56
Change of Fasting Insulin
Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL
Measured: baseline at Day0 and endline at Day56
Change of HOMA-IR
Change from baseline HOMA-IR at 8 weeks, is measured using formulation : glukosa (mg/dL) x insulin (µU/mL)/405
Measured: baseline at Day0 and endline at Day56
Change of Waist Circumference
Change from baseline Waist Circumference at 8 weeks, is measured in cm
Measured: baseline at Day0 and endline at Day56
Change of Carbohydrate intake
Change from baseline Carbohydrate intake at 8 weeks, is measured in gram using 24HR-recall
Measured: baseline at Day0 and endline at Day56
Change of Fat intake
Change from baseline Fat intake at 8 weeks, is measured in gram using 24HR-recall
Measured: baseline at Day0 and endline at Day56
Change of Protein intake
Change from baseline Protein intake at 8 weeks, is measured in gram using 24HR-recall
Measured: baseline at Day0 and endline at Day56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start16 Mar 2018
- Primary completion30 Jun 2018
- Study completion31 Oct 2018
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 ObesityStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Model description
- One group balance diet One group balance and sustainable diet
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Principal investigator, Rina Agustina, Universitas Indonesia
- Investigators
- Rina Agustina, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469869
- Sponsor's protocol ID
- YULIA-SAMI project
- Status last verified
- Feb 2019
- First submitted
- 27 Feb 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agustina R, Febriyanti E, Putri M, Martineta M, Hardiany NS, Mustikawati DE, Hanifa H, Shankar AH. Development and preliminary validity of an Indonesian mobile application for a balanced and sustainable diet for obesity management. BMC Public Health. 2022 Jun 20;22(1):1221. doi: 10.1186/s12889-022-13579-x.
PubMed 35725407
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia
- ClinicalTrials.gov ID
- NCT03469869
- Acronym / sponsor ID
- YULIA-SAMI project
- Conditions
- Obesity, Insulin Resistance, Inflammation, Blood Glucose, High
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 19 Mar 2018 (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 evaluates the effect of balanced and sustainable diet application on fat composition, insulin resistance and inflammation marker in obese people.
Intervention: Obese subject will receive intervention on balanced and sustainable diet application Control: Obese subject will receive a balanced diet application only
Detailed description
Maintaining the adherence of weight loss programme while selecting healthy and sustainable foods will become a worldwide future challenge in nutrition. Therefore, we investigated the suitable content, graphic, and flow in developing a mobile application as an alternative solution for enhancing the compliance of weight control and selecting healthy food with the least environmental impact.
The treatment for obesity consists of dieting, physical exercise, pharmacology, and surgery. Restricted balanced diet is a well known diet recommendation for people with obesity. Sustainable diet is an alternative form of diet which contributes to healthy life and is protective of biodiversity.
The main challenge in obesity management is the sustainability of weight loss programme. Mobile apps are an alternative solution for enhancing compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One group balance diet One group balance and sustainable diet
| Arm | Type | Receives |
|---|---|---|
| balanced and sustainable diet | Experimental | Other: balanced and sustainable dietThe intervention group will receive menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the control group will receive menu recommendation of balanced diet for 8 weeks. these menus are given in the apps |
| balanced diet | Active comparator | Other: balanced and sustainable dietthe intervention group receive get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will receive menu recommendation of balanced diet for 8 weeks. these menus are given in the apps |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index ≥ 25 kg/m2
- using Android-based smartphone
- willing to join this research by signing informed consent
Key exclusion criteria (7 listed)
- pale in physical examination
- in weight loss program
- have obesity with comorbidities
- have hormonal diseases
- consumed hormonal drug, PTU, anti diabetes drug
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 |
|---|---|---|
| balanced and sustainable dietthe intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp. the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp. | Other | balanced and sustainable diet, balanced diet |
Primary outcome
Change of body weight
Time frame: baseline at Day0 and endline at Day56
Change from baseline body weight at 8 weeks, is measured in kg
9 secondary outcomes
Change of Fat Mass
Time frame: baseline at Day0 and endline at Day56
Change of Fasting plasma glucose
Time frame: baseline at Day0 and endline at Day56
Change of TNF alpha
Time frame: baseline at Day0 and endline at Day56
Change of Fasting Insulin
Time frame: baseline at Day0 and endline at Day56
Change of HOMA-IR
Time frame: baseline at Day0 and endline at Day56
Change of Waist Circumference
Time frame: baseline at Day0 and endline at Day56
Change of Carbohydrate intake
Time frame: baseline at Day0 and endline at Day56
Change of Fat intake
Time frame: baseline at Day0 and endline at Day56
Change of Protein intake
Time frame: baseline at Day0 and endline at Day56
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 25 Feb 2019.
- Derived from this study: PubMed 35725407Agustina R, Febriyanti E, Putri M, Martineta M, Hardiany NS, Mustikawati DE, Hanifa H, Shankar AH. Development and preliminary validity of an Indonesian mobile application for a balanced and sustainable diet for obesity management. BMC Public Health. 2022 Jun 20;22(1):1221. doi: 10.1186/s12889-022-13579-x.
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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.
Rina Agustina, PhD principal investigator
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 balanced and sustainable diet in people with Obesity and Insulin Resistance, run by Universitas Indonesia 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 3 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 25 Feb 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 of body weight (time frame: baseline at Day0 and endline at Day56). 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 NCT03469869, 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 25 Feb 2019.