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
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJune 22, 2016
June 1, 2016
4 months
October 29, 2015
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nutritional status
Body weight and body height will be used to calculate body mass index
10 weeks
Secondary Outcomes (3)
Omega-3 Fatty Acid in plasma
10 weeks
Malondialdehyde plasma
10 weeks
alpha-Tocopherol plasma
10 weeks
Study Arms (2)
Enhanced Counseling using CFR based on LP
EXPERIMENTALThe 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.
General CFR Counseling
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Children with congenital disease and serious diseases
- Children with parent/caregiver who is illiterate
- Children with parent/caregiver who had communication disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indonesia Universitylead
- Danone Institute Internationalcollaborator
Study Sites (1)
Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun
Jakarta, DKI Jakarta, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. dr. MS SpGK
Study Record Dates
First Submitted
October 29, 2015
First Posted
October 30, 2015
Study Start
November 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
June 22, 2016
Record last verified: 2016-06