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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 8 April 2024
Main ID:  DRKS00006352
Date of registration: 28/01/2015
Prospective Registration: No
Primary sponsor: Institute of Biology Chemistry and Nutrition, University of Hohenheim
Public title: Association of household food security, dietary habits and nutritional status of women and children living in the food surplus areas, Central Java, Indonesia
Scientific title: Association of household food security, dietary habits and nutritional status of women and children living in the food surplus areas, Central Java, Indonesia
Date of first enrolment: 01/12/2014
Target sample size: 380
Recruitment status: Complete
URL:  http://drks.de/search/en/trial/DRKS00006352
Study type:  observational
Study design:  Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other  
Phase: 
Countries of recruitment
Indonesia
Contacts
Name: Ratna    Purwestri
Address:  Garbenstr 30 70599 Stuttgart Germany
Telephone: +49 711 45922498
Email: rc.purwestri@uni-hohenheim.de
Affiliation:  Institute of Biology Chemistry and Nutrition, University of Hohenheim
Name: Ratna    Purwestri
Address:  Garbenstrasse 30 70599 Stuttgart Germany
Telephone: +49 711 459 22948
Email: rc.purwestri@yahoo.com
Affiliation:  University of Hohenheim, Institute of Biological, Chemistry and Nutrition
Key inclusion & exclusion criteria
Inclusion criteria: Inclusion criteria of the respondents are pairs of mothers and their children below five years old coming from farmer background living in the selected area in Demak, Central Java who agree to join study by signing the informed consent form.

Minimum 74 sub sample of mothers and children are randomly selected for haemoglobin (Hb) level measurement and 7-day food stock questionnaire

Exclusion criteria: children with birth defekt

Age minimum: 16 Years
Age maximum: 70 Years
Gender: Female
Health Condition(s) or Problem(s) studied

E44
E43
Protein-energy malnutrition of moderate and mild degree
Unspecified severe protein-energy malnutrition
Intervention(s)
Group 1: Design of the study is an observational study, with inclusion criteria of mothers and their under five years old children from farmer background.

The mothers will answer almost all questions in the questionnaires only one time, including general characteristics, socio-economic conditions, health and nutrition related knowledge and practices, reported health status, retrospective breastfeeding practices, one day 24-hour recall food intake of mothers and children, agriculture-related knowledge and practices.
Weight and height are measured one time, too.

Sub sample of respondent is randomly selected for one time Hb level measurement.

The exception is only for 7-day food stock questionnaire for the sub sample respondent, which need to be asked for 7 days.
Primary Outcome(s)
Primary outcomes:
1. Nutritional status of mothers (BMI) and children (WHZ, HAZ and WAZ) by measuring their weight (using SECA weighing scale) and height (using height/lenght board), as well as Hb level of the sub sample of the respondents (using Hemocue). The measurement is carried out during interview/home visit session.
2. Food intake of mothers and children (fulfillment of macro and micronutrient intake) by interviewing one day 24-hour recall food intake during interview/home visit session.
3. Reported health status of mothers and children according to the structured questionnaires. The measurement is carried out during interview/home visit session.
4. Retrospective breastfeeding practices of the children by interviewing one day 24-hour recall food intake
5. Reported health and nutrition related knowledge of the mothers according to the structured questionnaires. The measurement is carried out during interview/home visit session.
6. Reported agriculture-related knowledge and practices according to the structured questionnaires. The measurement is carried out during interview/home visit session.

Secondary Outcome(s)
Sencondary outcomes:
1. 7 days household food stock according to structured questionnaires of 7 days food stock. The interviews are carried out during 7 days home visits
2. Health, nutrition and agriculture situation in our study area based on in-depth interview results from midwives, nutritionist from the local health centers, several mothers, head of village/village office staff, and focus group discussions. The interviews are carried out before and during the study.
Secondary ID(s)
Source(s) of Monetary Support
Neys-van Hoogstraten Foundation
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 07/10/2014
Contact:
kepk.fkub@gmail.com
University of Brawijaya, Faculty of Medicine
62 341 551611
kepk.fkub@gmail.com
Results
Results available:
Date Posted:
Date Completed: 28/02/2015
URL: http://drks.de/search/en/trial/DRKS00006352#studyResults
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