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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

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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02592109
Enrollment
38
Registered
2015-10-30
Start date
2015-11-30
Completion date
2016-03-31
Last updated
2016-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Complementary Feeding Recommendation, Linear Programming, Nutritional Status, Omega-3 Fatty Acids, Malondialdehyde, alpha-Tocopherol

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

Interventions

BEHAVIORALEnhanced Counseling using CFR based on Linear Programming

Sponsors

Danone Institute International
CollaboratorOTHER
Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
12 Months to 24 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Nutritional status10 weeksBody weight and body height will be used to calculate body mass index

Secondary

MeasureTime frame
Omega-3 Fatty Acid in plasma10 weeks
Malondialdehyde plasma10 weeks
alpha-Tocopherol plasma10 weeks

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026