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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

Primary Purpose

Complementary Feeding Recommendation, Linear Programming,, Nutritional Status

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Enhanced Counseling using CFR based on Linear Programming
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complementary Feeding Recommendation focused on measuring Complementary Feeding Recommendation, Linear Programming, Nutritional Status, Omega-3 Fatty Acids, Malondialdehyde, alpha-Tocopherol

Eligibility Criteria

12 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced Counseling using CFR based on LP

General CFR Counseling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Omega-3 Fatty Acid in plasma
Malondialdehyde plasma
alpha-Tocopherol plasma

Full Information

First Posted
October 29, 2015
Last Updated
June 21, 2016
Sponsor
Indonesia University
Collaborators
Danone Institute International
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1. Study Identification

Unique Protocol Identification Number
NCT02592109
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Danone Institute International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complementary Feeding Recommendation, Linear Programming,, Nutritional Status, Omega-3 Fatty Acids, Malondialdehyde, Alpha-Tocopherol, Overweight
Keywords
Complementary Feeding Recommendation, Linear Programming, Nutritional Status, Omega-3 Fatty Acids, Malondialdehyde, alpha-Tocopherol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Counseling using CFR based on LP
Arm Type
Experimental
Arm Description
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.
Arm Title
General CFR Counseling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Counseling using CFR based on Linear Programming
Primary Outcome Measure Information:
Title
Nutritional status
Description
Body weight and body height will be used to calculate body mass index
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Omega-3 Fatty Acid in plasma
Time Frame
10 weeks
Title
Malondialdehyde plasma
Time Frame
10 weeks
Title
alpha-Tocopherol plasma
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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