An interventional study of balanced and sustainable diet in Obesity, Insulin Resistance and Inflammation, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to female participants aged 19 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: balanced and sustainable diet
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
Other: balanced and sustainable diet
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.
Change of body weight
Change from baseline body weight at 8 weeks, is measured in kg
Time frame: baseline at Day0 and endline at Day56
Change of Fat Mass
Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg
Time frame: 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
Time frame: baseline at Day0 and endline at Day56
Change of TNF alpha
Change from baseline TNF alpha at 8 weeks, is measured in pg/ml
Time frame: baseline at Day0 and endline at Day56
Change of Fasting Insulin
Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL
Time frame: 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
Time frame: baseline at Day0 and endline at Day56
Change of Waist Circumference
Change from baseline Waist Circumference at 8 weeks, is measured in cm
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline at Day0 and endline at Day56
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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