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Main
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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. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007666 |
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Date of registration:
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09/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of lunch provision on the nutritional and health status of female garment workers: A randomized controlled intervention trial for six months in Phnom Penh, Cambodia
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Scientific title:
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Impact of lunch provision on the nutritional and health status of female garment workers: A randomized controlled intervention trial for six months in Phnom Penh, Cambodia - LUPROGAR |
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Date of first enrolment:
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07/04/2015 |
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Target sample size:
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360 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00007666 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: basic science
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Phase:
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N/A
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Countries of recruitment
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Cambodia
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Contacts
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Name:
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Jan
Makurat MSc |
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Address:
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Wilhelmstrasse 20
35392
Giessen
Germany |
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Telephone:
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+49 641 99 39046 |
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Email:
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jan.makurat@uni-giessen.de |
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Affiliation:
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Justus-Liebig-University GiessenInstitute of Nutritional Sciences |
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Name:
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Michael B.
Krawinkel |
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Address:
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Wilhelmstrasse 20
35392
Giessen
Germany |
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Telephone:
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+49 641 9939048 |
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Email:
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krawinkel@fb09.uni-giessen.de |
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Affiliation:
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Justus-Liebig-University GiessenInstitute of Nutritional Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Nulliparous and non-pregnant female garment workers aged 18-30 years.
Exclusion criteria: Chronic disease requiring treatment and/or medication. Subjects with handicaps or genetic disorders interfering with their nutritional and health status, severe anemia, signs of severe vitamin A deficiency and iodine deficiency.
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Malnutrition
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E40-E46
E50-E64
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E40-E46
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E50-E64
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Other nutritional deficiencies
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Intervention(s)
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Group 1: Intervention group: A standard lunch will be served daily (6days/week for 6 month) through a canteen run by a Cambodian caterer. The meal will typically consist of local available food items focusing on the intake of animal-source-foods, vegetables and fruits and will provide approx. 760 Kcal/meal.
Group 2: Control group: No lunch provision. The control group will receive the same benefits once the study is completed.
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Primary Outcome(s)
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Body weight: Measured at baseline and endline (after 6 month) to the nearest 0.01kg using a SECA-UNICEF scale (SECA, Hamburg, Germany).
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Secondary Outcome(s)
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BMI, triceps skinfold thickness & mid-upper arm circumference: Measured at baseline and endline. Body height will be measured using a calibrated height scale. A non-stretchable measuring tape will be used to measure mid-upper arm circumference. A skinfold caliper will be used to measure triceps skinfold thickness.
Iron, VitA, folate & VitB12 status: Measured at baseline and endline. Ferritin, soluble transferrin receptor, C-reactive protein, alpha-1-acid glycoprotein and retinol-binding protein concentrations will be determined by enzyme-immunoassays. Plasma folate and vitamin B12 concentrations will be determined using a commercial radio-immunoassay. Elevated C-reactive protein & alpha-1-acid glycoprotein concentrations, will be used to indicate the presence of subclinical inflammation/infection.
Anemia: Measured at baseline and endline. Using a HemoCue HB301 photometer (HemoCue, Ängelholm, Sweden).
Handgrip strength: Measured at baseline and endline. Will be measured in a sitting position using a Jamar handgrip dynamometer (Lafayette Instruments).
Morbidity: Measured at baseline, endline and after 3 months, using a pre-tested semi-quantitative questionnaire collecting data on illness history within the last 2 weeks prior the survey.
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Secondary ID(s)
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U1111-1165-8724
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Source(s) of Monetary Support
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Justus-Liebig-University Giessen
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Federal Ministry for Economic Cooperation and Development
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Ethics review
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Status: Approved
Approval date: 14/11/2014
Contact:
ethik.kommission@pharma.med.uni-giessen.de
Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
+49-641-9942470
ethik.kommission@pharma.med.uni-giessen.de
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