“Effectiveness of Locally Produced Peanut/Milk spread and Newly Developed Ready-to-Use Foods (RUF) for Malnourished Children in Nias Island, Indonesia”

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00006174
• Date of registration: 22/05/2014
• Prospective Registration: No
• Primary sponsor: Institute of Social Sciences in Agriculture, University of Hohenheim
• Public title: “Effectiveness of Locally Produced Peanut/Milk spread and Newly Developed Ready-to-Use Foods (RUF) for Malnourished Children in Nias Island, Indonesia”
• Scientific title: “Effectiveness of Locally Produced Peanut/Milk spread and Newly Developed Ready-to-Use Foods (RUF) for Malnourished Children in Nias Island, Indonesia”
• Date of first enrolment: 23/08/2007
• Target sample size: 250
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00006174
• Study type: interventional
• Study design: Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: other
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Veronika Scherbaum
• Affiliation: Institute of Social Sciences in Agriculture, University of Hohenheim

• Name: Ratna Purwestri
• Affiliation: Institute of Biology Chemistry and Nutrition, University of Hohenheim

Key inclusion & exclusion criteria

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.

Age minimum: 6 Months
Age maximum: 60 Months
Gender: All

Health Condition(s) or Problem(s) studied

E40-E46

E40-E46

Malnutrition

Intervention(s)

Group 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.
Group 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

Primary Outcome(s)

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(s)

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.

Source(s) of Monetary Support

Neys von Hoogstraten foundation

Church World Service

Eiselen Foundation (present: Fiat Panis Foundation)

Ethics review

Status: Approved
Approval date: 20/08/2007
Contact:

Ethical Committee of the Faculty of Medicine, University of Brawijaya, Malang, Indonesia [Ethical Committee of the Faculty of Medicine, University of Brawijaya, Malang, Indonesia ]

[phone]

Results

• Date Completed: 31/10/2008
• URL: http://drks.de/search/en/trial/DRKS00006174#studyResults