A Phase 2 interventional study of Enhanced Counseling using CFR based on Linear Programming in Complementary Feeding Recommendation, Linear Programming, and Nutritional Status, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 12 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-22.
Sponsored by Indonesia University · Phase 2, Interventional, and Treatment
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.
Randomized-Controlled-Trial with two arms of intervention:
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
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This study's enrollment of 38 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
The counseling will be done by individual face-to-face communications. The intervention's arm will get a counseling with an additional of 7-day cycle with adequate n-3 and optimal n-3/6 ratio for complementary feeding menu obtained from linear programming formulation. The counseling consisted of nutritional status in children aged 12-23 months and how to determine the nutritional status; the principle of balanced diet; definition, function, and source of omega-3; example of menu that contains adequate omega-3. The duration of counseling is approximately 30 minutes, once a week for ten weeks. The mother or caregiver will also receive daily menu for seven days that should be followed during the intervention. The daily menu comprised of 3 main meals and 2 snacks.
Behavioral: Enhanced Counseling using CFR based on Linear Programming
The control's arm will get general counseling combining balance diet and IYCF principal, which already been used by Ministry of Health, with additional of 7-day cycle menu guidance modified from existing or available menu which can be downloaded for public on Ministry of Health official website. The counseling consisted of nutritional status in children aged 12-23 months and how to determine the nutritional status; the principle of balanced diet based on Ministry of Health's Recommendation, and example of balanced diet menu. The duration of counseling is approximately 30 minutes, once a week for ten weeks. The mother or caregiver will also receive daily menu for seven days that should be followed during the intervention. The daily menu comprised of 3 main meals and 2 snacks.
Behavioral: Enhanced Counseling using CFR based on Linear Programming
Nutritional status
Body weight and body height will be used to calculate body mass index
Time frame: 10 weeks
Omega-3 Fatty Acid in plasma
Time frame: 10 weeks
Malondialdehyde plasma
Time frame: 10 weeks
alpha-Tocopherol plasma
Time frame: 10 weeks
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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