Clinical trial NCT03469869: Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People
Official title: The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Inflammation
Blood Glucose, High
Keywords: Obesity
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
First posted: 2018-03-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group balance diet One group balance and sustainable diet
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of body weight
timeFrame: baseline at Day0 and endline at Day56
Secondary outcomes:
measure: Change of Fat Mass
timeFrame: baseline at Day0 and endline at Day56
measure: Change of Fasting plasma glucose
timeFrame: baseline at Day0 and endline at Day56
measure: Change of TNF alpha
timeFrame: baseline at Day0 and endline at Day56
measure: Change of Fasting Insulin
timeFrame: baseline at Day0 and endline at Day56
measure: Change of HOMA-IR
timeFrame: baseline at Day0 and endline at Day56
measure: Change of Waist Circumference
timeFrame: baseline at Day0 and endline at Day56
measure: Change of Carbohydrate intake
timeFrame: baseline at Day0 and endline at Day56
measure: Change of Fat intake
timeFrame: baseline at Day0 and endline at Day56
measure: Change of Protein intake
timeFrame: baseline at Day0 and endline at Day56
Other outcomes:
Locations:
city: Depok
country: Indonesia
facility: University of Indonesia
state: West Java
Study officials:
affiliation: Indonesia University
name: Rina Agustina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.