“Effectiveness of Locally Produced Peanut/Milk spread and Newly Developed Ready-to-Use Foods (RUF) for Malnourished Children in Nias Island, Indonesia”
Organizational Data
- DRKS-ID:
- DRKS00006174
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2014-05-22
- Last update in DRKS:
- 2014-07-30
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Treatment effects of fortified cereal/nut/legume-based ready-to-use food biscuits for wasted children may be comparable to that of peanut/milk-spread, which were given in the daily or weekly programs. In distant areas on Nias Island, Indonesia, two nutritionally comparable forms of locally produced RUFs were given for supplementary feeding programs of moderately to mildly wasted children. This study intended to: 1) analyze the program outcomes in daily and weekly distribution and supervision of RUF-Nias biscuits programs, 2) to analyze the program outcomes in daily distribution and supervision of RUF-Nias biscuits and peanut/milk spread programs.
Brief summary in scientific language
Background: Ready-to-use foods (RUFs) in form of fortified cereal/nut/legume-based biscuits ( ±500 kcal and 8-10% protein per 100 g) were tested among moderately and mildly wasted children (WHZ ≥-3 to <-1.5 SD and were labelled as RUF-Nias biscuits and compared to the locally produced peanut/milk spread. Objectives: The objectives of the study were: 1. To analyze the program outcomes on anthropometric and nutritional indicators, length of stay until full recovery/program closure, compliance and cost in daily and weekly distribution and supervision of RUF-Nias biscuits programs. 2. To analyze the program outcomes on anthropometric and nutritional indicators, length of stay until full recovery/program closure, compliance and cost in daily distribution and supervision of RUF-Nias biscuits and peanut/milk spread programs. Methods: In the Church World Service (CWS) Nias project areas, all eligible children were recruited from community-based screening programs and admitted into existing nutrition centers managed by the community in Nias, Indonesia from October 2007 to June 2008. Discharge criterion of the programs was WHZ ≥-1.5 SD. Children who reached discharge criterion (RDC) were followed up at home about 4 to 5 months after program discharge for assessing long term effect of this food-based intervention study.
Health condition or problem studied
- ICD10:
- E40-E46 - Malnutrition
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Daily programs (distribution and supervision) of RUF-biscuits: Ready-to-use foods (RUFs) in form of fortified cereal/nut/legume-based biscuits (±500 kcal and 8-10% protein per 100 g) were tested among moderately and mildly wasted children (WHZ ≥-3 to <-1.5 SD) and were labelled as RUF-Nias biscuits and compared to the locally produced peanut/milk spread with similar nutrient content. The daily portion of RUF-Nias biscuits given was based on the actual weight of the individual child, offered in a supervised setting and calculated to cover about 60% of the recommended daily energy intake (± 500 kcal), as per Indonesian guidelines (Departemen Kesehatan RI, 2003). A child with body weight ± 9 kg received 6-7 RUF-Nias biscuits per day (total weight of biscuits about 100 g). The RUF biscuits were offered as snacks and should not interrupt with home-made meals and/or breastfeeding practices. Since the centers opened every day, therefore the children received their prescribed daily portion every day. The children were encouraged to consume the RUF biscuits on-site. The rest of biscuits were given as take-home ration for that particular day. Arm 1. Moderately and mildly wasted children (WHZ ≥-3 to <-1.5 SD) were given locally produced RUF-Nias biscuits within daily programs until they reached discharge criterion or program closure. Program discharge criterion was WHZ >-1.5 SD.
- Arm 2:
- Arm 2. Weekly programs (distribution and supervision) of RUF-biscuits: Moderately and mildly wasted children (WHZ ≥-3 to <-1.5 SD) were given locally produced RUF-Nias biscuits within weeky programs until they reached discharge criterion or program closure. Program discharge criterion was WHZ >-1.5 SD. The daily portion of RUF-Nias biscuits was given based on the actual weight of the individual child, offered in a supervised setting and calculated to cover about 60% of the recommended daily energy intake (± 500 kcal), as per Indonesian guidelines (Departemen Kesehatan RI, 2003). A child with body weight ± 9 kg received 6-7 RUF-Nias biscuits per day (total weight of biscuits about 100 g). The RUF biscuits were offered as snacks and should not interrupt with home-made meals and/or breastfeeding practices. Since nutrition centers were openned on weekly basis, the children received weekly take-home ration of RUF biscuits.
- Arm 3:
- Arm 3. Moderately and mildly wasted children (WHZ ≥-3 to <-1.5 SD) were given locally produced peanut/milk spread within daily programs until they reached discharge criterion or program closure. Program discharge criterion was WHZ >-1.5 SD. The daily portion of peanut/milk spread were given based on the actual weight of the individual child, offered in a supervised setting and calculated to cover about 60% of the recommended daily energy intake (± 500 kcal), as per Indonesian guidelines (Departemen Kesehatan RI, 2003). A child with body weight ± 9 kg received one portion (about 100 g) of peanut/milk spread. The spread were offered as snacks and should not interrupt with home-made meals and/or breastfeeding practices. Since nutrition centers were openned on daily basis, if the children were not able to finish the given daily portion, the rest was given for take-home ration and should be finished within one day.
Endpoints
- Primary outcome:
- Primary outcomes were collected before, during and after admission to the program. 1. Anthropometry measurement namely: weight (using hanging scale), height (using length/height board), and mid-upper arm circumference (MUAC) status (using Indonesian Ministry of Health measurement tape) and their improvements. Height and weight were collected prior to admission, during and after program period. During program peridod, in Daily programs: weight of children were measured 2-3x per week, while Weekly programs: 1x per week. Height measurement were done 1x per month for both Daily and Weekly programs. Additionally, MUAC data were collected before admission and after program discharge/closure. 2. Standard deviation score of weight-for-height and height-for-age Z-score and their improvements (analyzing using ENA software, www.nutrisurvey.de). SD score for WHZ and HAZ of the children were derived from anthropometric data (weight and height of the children). Every week, WHZ-score of the children were calculated to assess the nutritional improvement of the children. 3. Length of stay in the program until reaching discharge criterion or at program closure (calculation based on date of admission and date of program discharge/closure). Length of stay data were calculated after program discharge/closure. 4. Haemoglobin (Hb) status and its improvement (using hemocue). Hb finger prick blood collection were collected before admission and after program discharge/closure. 5. Incidence of illness during program period (analysis based on morbidity monitoring questionnaire). Monitoring of morbidity was carried out every day (in daily program) or every week (in weekly program). Calculation of incidence were done after program discharge/closure. Additionally, frequency of implementation during program period 1. On-site RUF biscuit’intake supervision: Daily programs: 1x per day; Weekly programs: 1x per week using questionnaire 2. Recall and monitoring on: -take-home ration of RUF biscuit’intake and child morbidity: Daily program: 1x per day; Weekly program: 1x per week using questionnaire 3. Monitoring on child anthropometry: Daily programs: weight 2-3x per week; Weekly programs: 1x per week height 1x per month 1x per month
- Secondary outcome:
- In addition socio-economic condition, program cost (institutional and social investment) was calculated, in-depth interview on the reasons of not reaching discharge criterion and follow-up assessment of those children who reached discharge criterion were performed. Socio economic conditions were gathered using structured questionnaire. Institutional and social investment were calculated from the NGO documentation (financial reports, including material and equipments to run the programs, salary, etc), as well as interviews to mothers, voluntary workers, field officers (for social cost) In-depth interviews were done using guidelines questions for mothers whose children did not reach discharge criteria for investigating the reasons. Approximately 5-6 months after program discharge/closure, children who reached discharge criterion were home visited. Weight and height were measured by weighing (using hanging scale) and measuring the height of the child (using length/height board) to assess the long-term effect of supplementary feeding to nutritional status of the children.
Study Design
- Purpose:
- Other
- Allocation:
- Non-randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- 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:
-
- Indonesia
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Other community management of acute malnutrition (CMAM) center in Church World Service project area Nias island
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2007-08-23
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2008-10-31
- Target Sample Size:
- 250
- Final Sample Size:
- 271
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 6 Months
- Maximum Age:
- 60 Months
- Additional Inclusion Criteria:
- The admission criteria included mildly/moderately wasted children (WHZ ≥-3 to <-1.5 SD) according to NCHS, aged ≥ 6 months up to < 60 months
Exclusion Criteria
no birth defect or disease which could limit the ad libitum food intake.
Addresses
Primary Sponsor
- Address:
- Institute of Social Sciences in Agriculture, University of HohenheimDr. Veronika ScherbaumFruwirthstr 14-1670599 StuttgartGermany
- Telephone:
- +49 711 459 23496
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-hohenheim.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institute of Biology Chemistry and Nutrition, University of HohenheimDr. Ratna PurwestriGarbenstr 3070599 StuttgartGermany
- Telephone:
- +49 711 45922498
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-hohenheim.de
Contact for Public Queries
- Address:
- Institute of Social Sciences in Agriculture, University of HohenheimDr. Veronika ScherbaumFruwirthstr 14-1670599 StuttgartGermany
- Telephone:
- +49 711 459 23496
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-hohenheim.de
Principal Investigator
- Address:
- Institute of Biology Chemistry and Nutrition, University of HohenheimDr. Ratna PurwestriGarbenstr 3070599 StuttgartGermany
- Telephone:
- +49 711 45922498
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-hohenheim.de
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Neys von Hoogstraten foundationc/o SPAN Consultants Binckhorstlaan 36 M 352 2516 BE2516 BE The HagueNetherlands
- Telephone:
- +31 (0)70 750 4808
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neys-vanhoogstraten.nl/
Private sponsorship (foundations, study societies, etc.)
- Address:
- Church World ServiceChurchWorld Service, 475 Riverside Drive, 700 SuiteNY 10115 New YorkUnited States
- Telephone:
- +1 212 870 2798
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.cwsglobal.org
Private sponsorship (foundations, study societies, etc.)
- Address:
- Eiselen Foundation (present: Fiat Panis Foundation)Eiselen-Foundation Ulm Fürsteneckerstr. 1789077 UlmGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.stiftung-fiat-panis.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethical Committee of the Faculty of Medicine, University of Brawijaya, Malang, Indonesia [Ethical Committee of the Faculty of Medicine, University of Brawijaya, Malang, Indonesia ]Prof Dr. dr , SpS, SpBS M. Istiadjid Edy SantosoVeteran Street Malang East Java65145 MalangIndonesia
- Telephone:
- +62 341 569117
- Fax:
- +62 341 564755
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ub.ac.id/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2007-08-06
- Ethics committee number:
- No. 25/PEPK/VIII/2007
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2007-08-20
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT 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:
- No Entry
- 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