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

Phase 2

Completed

• Conditions: Alpha-Tocopherol; Malondialdehyde; Complementary Feeding Recommendation; Overweight; Linear Programming,; Omega-3 Fatty Acids; Nutritional Status

• Registration Number: NCT02592109
• Lead Sponsor: Indonesia University

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

Study Timeline

• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Start: 2015-11
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nutritional status	10 weeks	Body weight and body height will be used to calculate body mass index

Secondary Outcome Measures

Name	Time	Method
Omega-3 Fatty Acid in plasma	10 weeks
Malondialdehyde plasma	10 weeks
alpha-Tocopherol plasma	10 weeks

Trial Locations

Locations (1)

Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun; 🇮🇩 Jakarta, DKI Jakarta, Indonesia