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临床试验/NCT02592109
NCT02592109已完成2 期

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

Indonesia University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
38
试验地点
1
主要终点
Nutritional status

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
12 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Children with congenital disease and serious diseases
  • Children with parent/caregiver who is illiterate
  • Children with parent/caregiver who had communication disability

结局指标

主要结局

Nutritional status

时间窗: 10 weeks

Body weight and body height will be used to calculate body mass index

次要结局

  • Omega-3 Fatty Acid in plasma(10 weeks)
  • Malondialdehyde plasma(10 weeks)
  • alpha-Tocopherol plasma(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Inge Permadhi

Dr. dr. MS SpGK

Indonesia University

研究点 (1)

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