Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status,Omega-3 Fatty Acids, Malondialdehyde, and Alpha-Tocopherol in Overweight Children in East Jakarta

Overweight Clinical Trial

Official title:
Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status, Omega-3 Fatty Acid, Malondialdehyde, and Alpha-Tocopherol in Children With Risk of Overweight in East Jakarta

Status Completed

Clinical Trial Summary

The epidemic of pediatric obesity has become a public health burden in both developed and developing countries, due to its serious health consequences, including an increased risk of type 2 Diabetes Mellitus and heart disease. Currently, dietary and exercise changes are still the center of preventive and treatment measures of obesity. Recently, the omega-3 group, one of the groups of polyunsaturated fatty acids (PUFAs), has been associated with many positive effects leading to the improvement of many diseases related to obesity. Nevertheless, the consumption of this essential nutrient requires certain ration to optimize its favorable result. Although previous studies have examined the efficacy of dietary counseling approach as treatment for obesity, none of them as explicitly explore the use of linear programming to create a tailored diet containing high omega-3 fatty acid food as a part of dietary counseling in obesity management program among children. Thus, this study is intended to contribute the clinical evidence regarding this area of knowledge, specifically the effects of enhanced counseling containing complementary feeding recommendation on nutritional status, omega-3 fatty acid, malondialdehyde, and alpha Tocopherol among children with risk of overweight aged 12 -23 months in East Jakarta.

Clinical Trial Description

Randomized-Controlled-Trial with two arms of intervention:

1. Control group: receive standard counseling with general existing menu recommendation

2. Intervention group: receive enhanced counseling (additional information on omega-3 fatty acids) with population-based menu ganerated from linear programming (LP)

There is a protocol on stratified block randomization. 2 blocks, stratified by: area, age, BMI-for-age status.

Total sample size for analysis:

Overall: 20 control - 18 intervention Blood sample: 18 control - 14 intervention ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02592109
Study type	Interventional
Source	Indonesia University
Contact
Status	Completed
Phase	Phase 2
Start date	November 2015
Completion date	March 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Terminated	`NCT03299881` - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss	N/A
Completed	`NCT02805478` - Fat-Associated Cardiovascular Organ Dysfunction
Active, not recruiting	`NCT02558920` - Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
Completed	`NCT03759743` - Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject	N/A
Completed	`NCT03610958` - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.	N/A
Completed	`NCT03678766` - CHARGE: Controlling Hunger and ReGulating Eating	N/A
Completed	`NCT04430465` - Effects of Wholegrains on Children's Health (KORN)	N/A
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT05376865` - Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers	N/A
Completed	`NCT03625427` - Effect of Palmitoleic Acid on C-reactive Protein	N/A
Active, not recruiting	`NCT03435445` - Online Platform for Healthy Weight Loss (POEmaS)	N/A
Enrolling by invitation	`NCT05576116` - Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics	N/A
Recruiting	`NCT05249465` - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention	N/A
Active, not recruiting	`NCT06023095` - A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities	Phase 1
Completed	`NCT03648892` - Brain Dopamine Function in Human Obesity	Early Phase 1
Not yet recruiting	`NCT05751993` - Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions	N/A
Recruiting	`NCT02887950` - Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause	N/A
Terminated	`NCT02743598` - Liraglutide for HIV-associated Neurocognitive Disorder	Phase 4
Completed	`NCT03097237` - High Fiber Rye Foods for Weight and Body Fat Reduction	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.