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Completed

NCT Number: NCT02592109

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

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.

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Key information

Age range

12 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun

Jakarta, DKI Jakarta, Indonesia

About this study

Randomized-Controlled-Trial with two arms of intervention:

  • Control group: receive standard counseling with general existing menu recommendation
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Counseling using CFR based on Linear Programming

Behavioral

Primary outcomes

  1. Nutritional status

    Time frame: 10 weeks

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

Secondary outcomes

  1. Omega-3 Fatty Acid in plasma

    Time frame: 10 weeks

  2. Malondialdehyde plasma

    Time frame: 10 weeks

  3. alpha-Tocopherol plasma

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Danone Institute International

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2015
Registry last updated
Jun 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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