Clinical trial NCT02592109: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complementary Feeding Recommendation
Linear Programming,
Nutritional Status
Omega-3 Fatty Acids
Malondialdehyde
Alpha-Tocopherol
Overweight
Keywords: Complementary Feeding Recommendation
Linear Programming
Nutritional Status
Omega-3 Fatty Acids
Malondialdehyde
alpha-Tocopherol
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Danone Institute International
First posted: 2015-10-30
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Nutritional status
timeFrame: 10 weeks
Secondary outcomes:
measure: Omega-3 Fatty Acid in plasma
timeFrame: 10 weeks
measure: Malondialdehyde plasma
timeFrame: 10 weeks
measure: alpha-Tocopherol plasma
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun
state: DKI Jakarta
Study officials:
References: