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Completed

NCT Number: NCT03469869

Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People

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

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Key information

Conditions

Obesity Blood Glucose, High Body Weight Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Indonesia

Depok, West Java, 16424, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index ≥ 25 kg/m2
  • using Android-based smartphone
  • willing to join this research by signing informed consent

Exclusion criteria

  • 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

Treatment and study plan

balanced and sustainable diet

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change of Fat Mass

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg

  2. Change of Fasting plasma glucose

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline Fasting plasma glucose at 8 weeks, is measured in mg/dL

  3. Change of TNF alpha

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline TNF alpha at 8 weeks, is measured in pg/ml

  4. Change of Fasting Insulin

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL

  5. Change of HOMA-IR

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline HOMA-IR at 8 weeks, is measured using formulation : glukosa (mg/dL) x insulin (µU/mL)/405

  6. Change of Waist Circumference

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline Waist Circumference at 8 weeks, is measured in cm

  7. Change of Carbohydrate intake

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline Carbohydrate intake at 8 weeks, is measured in gram using 24HR-recall

  8. Change of Fat intake

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline Fat intake at 8 weeks, is measured in gram using 24HR-recall

  9. Change of Protein intake

    Time frame: baseline at Day0 and endline at Day56

    Change from baseline Protein intake at 8 weeks, is measured in gram using 24HR-recall

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Fakultas Kedokteran Universitas Indonesia

Registry information

Official study title

The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2018
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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