Overweight Clinical Trial
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
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Months to 24 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun | Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University | Danone Institute International |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nutritional status | Body weight and body height will be used to calculate body mass index | 10 weeks | No |
Secondary | Omega-3 Fatty Acid in plasma | 10 weeks | No | |
Secondary | Malondialdehyde plasma | 10 weeks | No | |
Secondary | alpha-Tocopherol plasma | 10 weeks | No |
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