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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592109
• Other study ID #: IPermadhi
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2015
• Last updated: June 21, 2016
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alpha-Tocopherol
• Complementary Feeding Recommendation
• Linear Programming,
• Malondialdehyde
• Nutritional Status
• Omega-3 Fatty Acids
• Overweight

Intervention

Behavioral:
• Enhanced Counseling using CFR based on Linear Programming

Locations

Country	Name	City	State
Indonesia	Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Danone Institute International

Country where clinical trial is conducted

Indonesia, 

Outcome

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