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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

Organizational Data

DRKS-ID:
DRKS00007666
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2015-01-09
Last update in DRKS:
2016-04-27
Registration type:
Prospective

Acronym/abbreviation of the study

LUPROGAR

URL of the study

No Entry

Brief summary in lay language

Malnutrition is prevalent among female garment workers in Cambodia and generally associated with numerous poor health related outcomes. The objective of the LUPROGAR study is to determine the impact of daily lunch provision on the nutritional and health status of female garment workers. Canteens in garment factories are expected to improve the nutritional and health status of workers and to reduce absenteeism. The study is planned as an intervention for the duration of six months in a selected factory in Phnom Penh province, Cambodia. Healthy and non-pregnant workers aged 18-30 years will be randomly invited to participate in the study until the intended sample size of 360 participants is reached. Enrolled participants will be randomly categorized into intervention (n=180, lunch provision) or control group (n=180, no provision). The control group will receive the same benfits once the study is completed. Several variables will be assessed before and after the intervention by means of anthropometric screening, blood analysis, stool analysis, handgrip dynamometer and different questionnaires. A standard lunch will be served on every workday (6days/week) through a canteen run by a local caterer. The meal will typically consist of local available food items focusing on the intake of animal-source-foods, vegetables and fruits.

Brief summary in scientific language

Malnutrition is prevalent among female garment workers in Cambodia and generally associated with numerous poor health related outcomes. The establishment of staff canteens was proposed as an intervention expected to improve the nutritional and health status of workers and benefitting the factories through increased productivity. The objective of the LUPROGAR study is to determine the impact of daily lunch provision of adequate nutritional quantity and quality on anthropometry and micronutrient status, as well as on anemia prevalence, handgrip strength, morbidity and absenteeism among workers. The study is planned as a two-group randomized controlled intervention trial for six months in a purposely selected factory in Phnom Penh province, Cambodia. Eligible subjects, healthy and non-pregnant workers aged 18-30 years, will be randomly invited by trained assistants to participate in the study until the intended sample size is reached. Those who agree will be seen by a nurse/clinician. Enrolled participants will be stratified according to relevant variables (age, duration of employment & function) and randomly categorized into intervention (n=180) or control group (n=180) to ensure structural equality. Several variables will be assessed by anthropometric screening (weight, height, triceps skinfold & mid-upper arm circumference), blood analysis (hemoglobin, ferritin, soluble transferrin receptor, C-reactive protein, alpha-1-acid glycoprotein, retinol-binding protein, folate and vitamin B12), stool analysis (parasite infestation), handgrip dynamometer and three different questionnaires (socio-economic status, individual dietary diversity and illness history). A standard lunch will be served daily (6days/week) 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. The control group will receive the same benefits once the study is completed.

Health condition or problem studied

ICD10:
E40-E46 - Malnutrition
ICD10:
E50-E64 - Other nutritional deficiencies
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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.
Arm 2:
Control group: No lunch provision. The control group will receive the same benefits once the study is completed.

Endpoints

Primary outcome:
Body weight: Measured at baseline and endline (after 6 month) to the nearest 0.01kg using a SECA-UNICEF scale (SECA, Hamburg, Germany).
Secondary outcome:
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.

Study Design

Purpose:
Basic research/physiological study
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Cambodia
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Phnom Penh

Recruitment period and number of participants

Planned study start date:
2015-03-16
Actual study start date:
2015-04-07
Planned study completion date:
No Entry
Actual Study Completion Date:
2015-10-31
Target Sample Size:
360
Final Sample Size:
223

Inclusion Criteria

Sex:
Female
Minimum Age:
18 Years
Maximum Age:
30 Years
Additional 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.

Addresses

Primary Sponsor

Justus-Liebig-University GiessenInstitute of Nutritional Sciences
Prof. Dr. Michael B. Krawinkel
Wilhelmstrasse 20
35392 Giessen
Germany
Telephone:
+49 641 9939048
Fax:
+49 641 9939039
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Justus-Liebig-University GiessenInstitute of Nutritional Sciences
Prof.Dr. Michael B. Krawinkel
Wilhelmstrasse 20
35392 Giessen
Germany
Telephone:
+49 641 9939048
Fax:
+49 641 9939039
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Justus-Liebig-University GiessenInstitute of Nutritional Sciences
Jan Makurat MSc
Wilhelmstrasse 20
35392 Giessen
Germany
Telephone:
+49 641 99 39046
Fax:
+49 641 99 39039
Contact per E-Mail
URL:
No Entry

Principal Investigator

Justus-Liebig-University GiessenInstitute of Nutritional Sciences
Prof.Dr. Michael B. Krawinkel
Wilhelmstrasse 20
35392 Giessen
Germany
Telephone:
+49 641 9939048
Fax:
+49 641 9939039
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Federal Ministry for Economic Cooperation and Development
Dahlmannstraße 4
53113 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Justus-Liebig-University Giessen
Ludwigstrasse 23
35390 Giessen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
Frankfurter Straße 51-53
35392 Gießen
Germany
Telephone:
+49-641-9942470
Fax:
+49-641-9942479
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-10-13
Ethics committee number:
198/14
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-11-14

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1165-8724
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry