Trials / Completed
CompletedNCT02592109
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Indonesia University · Academic / Other
- Sex
- All
- Age
- 12 Months – 24 Months
- Healthy volunteers
- Accepted
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
Conditions
- Complementary Feeding Recommendation
- Linear Programming,
- Nutritional Status
- Omega-3 Fatty Acids
- Malondialdehyde
- Alpha-Tocopherol
- Overweight
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Enhanced Counseling using CFR based on Linear Programming |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2015-10-30
- Last updated
- 2016-06-22
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT02592109. Inclusion in this directory is not an endorsement.