A Multicenter Randomized Controlled Trial of Food Supplement Treatment for Wasting Children in Indonesia - Study Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Nutritional status of wasting children
研究概览
简要总结
Assessing program efficacy of under five food supplementation (PMT Biscuits) is needed after the first 6 months of exclusive breastfeeding, children were introduced to liquid and semi-solid food. In this phase of food introduction, children ability to accept food supplementation program was still questionable and the efficacy needs to be assessed.
Another aspect that needed to be evaluated is assessing the efficacy of food supplementation to improve the nutritional status of wasting children in multiple cities to describe Indonesian geographical and socio-economic diversity (multi center studies). PMT biscuits supplementation intervention is accompanied by educational modules on Infant and Young Child Feeding (IYCF) in order to improve caregiver's knowledge and skills in providing economically affordable and nutritious food for their children. PMT biscuits supplementation evaluation will be assessed at 9 months observations (3 months intervals). The observation will be conducted every month up until the first 3 months then the observation will be continued in 6th and 9th months of observation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-17 months (still included in under two years old children during the intervention period)
- •Underweight children by weight-per-height less than -2.00
- •Not received PMT Biscuits at the time of recruitment
- •Parents agree to follow the research
排除标准
- •Severe wasting (weight for height less than -3 Z-score)
- •Severe food insecurity households (Severe Household Food Insecurity)
- •Tuberculosis infection based on anamnesis
- •The possibility of moving to another city within 6 months of intervention
研究组 & 干预措施
Control group
The first arm as a control group obtaining only routine IYCF consultation by the posyandu (integrated health service post) cadres and without the provision of biscuits.
National portion & IYCF counseling
The second arm as the national portion & IYCF counseling group to get biscuit with standardized portion as recommended by Ministry of Health and also given the IYCF counseling by the cadres and nutritionist.In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
干预措施: National portion & IYCF counseling (Other)
Adjusted portion & local food counseling
the third arm as the adjusted portion & local food counseling group receiving biscuit with adjustment in portion and IYCF Counseling that emphasize the optimization of local food. In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
干预措施: Adjusted portion & local food counseling (Other)
结局指标
主要结局
Nutritional status of wasting children
时间窗: Through study completion, an average of 1 year. Measurement on changes in nutritional status from baseline and at third, sixth, & ninth months
Anthropometry measurement based on weight-for-length indicator (The WHO Child Growth Standards). Weight will be measured in kilograms using an equivalent quality measurement tool using SECA scales. The measuring instrument to be used in measuring the length of the child is a Shorrboard with a unit of cm, precision of 0.1 cm.
次要结局
- PMT biscuits compliance(Through study completion, an average of 1 year. At the first to third months after treatment started, then continued to be observed at the sixth and ninth months from the beginning of treatment.)
研究者
Muchtaruddin Mansyur
Principal Investigator
SEAMEO Regional Centre for Food and Nutrition