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Food Supplement Treatment for Wasting Children in Indonesia

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ClinicalTrials.gov Identifier: NCT03509155
Recruitment Status : Active, not recruiting
First Posted : April 26, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Muchtaruddin Mansyur, SEAMEO Regional Centre for Food and Nutrition

Brief Summary:

Assessing program efficacy of under five food supplementation (PMT Biscuits) is needed after the first 6 months of exclusive breastfeeding, children were introduced to liquid and semi-solid food. In this phase of food introduction, children ability to accept food supplementation program was still questionable and the efficacy needs to be assessed.

Another aspect that needed to be evaluated is assessing the efficacy of food supplementation to improve the nutritional status of wasting children in multiple cities to describe Indonesian geographical and socio-economic diversity (multi center studies). PMT biscuits supplementation intervention is accompanied by educational modules on Infant and Young Child Feeding (IYCF) in order to improve caregiver's knowledge and skills in providing economically affordable and nutritious food for their children. PMT biscuits supplementation evaluation will be assessed at 9 months observations (3 months intervals). The observation will be conducted every month up until the first 3 months then the observation will be continued in 6th and 9th months of observation.


Condition or disease Intervention/treatment Phase
Wasting Nutrition Disorder, Child Other: National portion & IYCF counseling Other: Adjusted portion & local food counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The intervention is running parallel in three arms.

  1. The first arm as a control group obtaining only routine IYCF counseling by the cadre and without the provision of biscuits. If there are respondents at the first three months data collection who experience a decrease in nutritional status, then the respondent will be given biscuits immediately
  2. The second arm as the first intervention group to get biscuit with portion as recommended by Ministry of Health and also given the IYCF counseling by the cadres and nutritionist
  3. The third arm as the second intervention group receiving biscuit with adjustment in portion and IYCF Counseling that emphasize the optimization of local food In the 2nd and 3rd arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter Randomized Controlled Trial of Food Supplement Treatment for Wasting Children in Indonesia - Study Protocol
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
The first arm as a control group obtaining only routine IYCF consultation by the posyandu (integrated health service post) cadres and without the provision of biscuits.
Active Comparator: National portion & IYCF counseling
The second arm as the national portion & IYCF counseling group to get biscuit with standardized portion as recommended by Ministry of Health and also given the IYCF counseling by the cadres and nutritionist.In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
Other: National portion & IYCF counseling
Eight or twelve pieces of Biscuits supplementation per day as serving size recommendation based on the requirement from Ministry of Health, accompanied by IYCF Counseling emphasizing on local food optimization. The difference in serving size recommendation will be evaluated to see the efficacy of Biscuits supplementation on wasting children age 6-23 months of age

Experimental: Adjusted portion & local food counseling
the third arm as the adjusted portion & local food counseling group receiving biscuit with adjustment in portion and IYCF Counseling that emphasize the optimization of local food. In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
Other: Adjusted portion & local food counseling
four pieces of Biscuits supplementation per day as serving size recommendation, accompanied by IYCF Counseling. The difference in serving size recommendation will be evaluated to see the efficacy of Biscuits supplementation on wasting children age 6-23 months of age




Primary Outcome Measures :
  1. Nutritional status of wasting children [ Time Frame: Through study completion, an average of 1 year. Measurement on changes in nutritional status from baseline and at third, sixth, & ninth months ]
    Anthropometry measurement based on weight-for-length indicator (The WHO Child Growth Standards). Weight will be measured in kilograms using an equivalent quality measurement tool using SECA scales. The measuring instrument to be used in measuring the length of the child is a Shorrboard with a unit of cm, precision of 0.1 cm.


Secondary Outcome Measures :
  1. PMT biscuits compliance [ Time Frame: Through study completion, an average of 1 year. At the first to third months after treatment started, then continued to be observed at the sixth and ninth months from the beginning of treatment. ]
    The caregiver will be asked to fill a form every day noting on how many biscuits the children eat and its remaining stock for that day. The form will be collected by enumerator while doing regular observation.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6-17 months (still included in under two years old children during the intervention period)
  • Underweight children by weight-per-height less than -2.00
  • Not received PMT Biscuits at the time of recruitment
  • Parents agree to follow the research

Exclusion Criteria:

  • Severe wasting (weight for height less than -3 Z-score)
  • Severe food insecurity households (Severe Household Food Insecurity)
  • Tuberculosis infection based on anamnesis
  • The possibility of moving to another city within 6 months of intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509155


Locations
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Indonesia
Seameo Regional Center for Food and Nutrition
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
SEAMEO Regional Centre for Food and Nutrition
Investigators
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Principal Investigator: Muchtaruddin Mansyur, PhD Seameo Regional Center For Food And Nutrition

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Muchtaruddin Mansyur, Principal Investigator, SEAMEO Regional Centre for Food and Nutrition
ClinicalTrials.gov Identifier: NCT03509155     History of Changes
Other Study ID Numbers: PMT2017
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Muchtaruddin Mansyur, SEAMEO Regional Centre for Food and Nutrition:
Infant and Young Child Feeding
Program Evaluation
Food Supplementation
Biscuit
wasting children

Additional relevant MeSH terms:
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Cachexia
Wasting Syndrome
Nutrition Disorders
Child Nutrition Disorders
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases