Skip to main content
Clinical Trials/NCT02592109
NCT02592109
Completed
Phase 2

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

Indonesia University1 site in 1 country38 target enrollmentNovember 2015

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Complementary Feeding Recommendation
Sponsor
Indonesia University
Enrollment
38
Locations
1
Primary Endpoint
Nutritional status
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Inge Permadhi

Dr. dr. MS SpGK

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • aged 12-23 months old at first counseling
  • body mass index more than +1 standard deviation in WHO Z-score
  • parent agree to participate in the study by signing informed consent

Exclusion Criteria

  • Children with congenital disease and serious diseases
  • Children with parent/caregiver who is illiterate
  • Children with parent/caregiver who had communication disability

Outcomes

Primary Outcomes

Nutritional status

Time Frame: 10 weeks

Body weight and body height will be used to calculate body mass index

Secondary Outcomes

  • Omega-3 Fatty Acid in plasma(10 weeks)
  • Malondialdehyde plasma(10 weeks)
  • alpha-Tocopherol plasma(10 weeks)

Study Sites (1)

Loading locations...

Similar Trials