Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children
试验速览
- 阶段
- 3 期
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Nutritional status
研究概览
简要总结
WHO has urged all developing countries to develop programmes to improve complementary-feeding (CF) practices because of their importance for optimal growth, development and health of infants and young children While supplementation programmes and/or highly-fortified "super-foods" have limited success in improving CF-practices in disadvantaged environments, population-specific food-based dietary guidelines (FBDG), based on locally-available foods and requires minimal changes to local food pattern, will enhance the chances of programme success.
Our previous study was able to identify the need for, potential and finally develop FBDG for CF of 6-8mo and 9-11mo infants using combined linear-and-goal programming approach (LP approach). This research is therefore being made to support the next phase of the study i.e. to assess the efficacy of FBDG, for improving CF/dietary-practices and growth in <24mo children (window of opportunity). As growth and development is inter-related, home-based stimulation will be included in this trial to see the effect on child development. While studies have shown that stimulation at early age benefits children through their late adolescence; evidence from Indonesia is lacking. This study therefore aims to see the effect on growth and development of community trial using food-based dietary guideline and stimulation. It is expected that findings from this study will provide scientific evidence as the basis for program formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 9 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children aged 9-11 month on enrolment,
- •weight-for-age Z-score <-1.00 but >-3.00
排除标准
- •having mental or physical disabilities
研究组 & 干预措施
FBDG group
The group received Food Based Dietary Guidelines for feeding recommendation. Monthly-session with group of mothers involving interactive activities e.g. cooking session, cooking competition and games.
干预措施: FBDG group (Other)
Stimulation group
The children received psychosocial stimulation from the mothers. Mothers were taught on psychosocial module which was developed using locally existing resources and was directed at improving four aspects of child development, namely gross motoric, fine motor, language and socio-emotional developments.
干预措施: Stimulation (Other)
Combined (FBDG and Stimulation)
The group received both FBDG and psychosocial stimulation
干预措施: FBDG group (Other)
Combined (FBDG and Stimulation)
The group received both FBDG and psychosocial stimulation
干预措施: Stimulation (Other)
Combined (FBDG and Stimulation)
The group received both FBDG and psychosocial stimulation
干预措施: Combinded FBDG and stimulation (Other)
Control
The group received standard health education messages from existing health care system.
干预措施: Control group (Other)
结局指标
主要结局
Nutritional status
时间窗: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)
Anthropometry status (Height for age, weight for height, weight for age, BMI for age), Hemoglobin, iron status (serum ferritin, transferrin receptor), vitamin A status (RBP). Iron and vitamin A status were measured only at follow up
Child development
时间窗: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)
Child development was measured using Bayley Scale of Infant Development II (BSID-II) at baseline and 6mo after the intervention (endline). Two years after the endline (the follow-up), child development was measured using Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV).
次要结局
未报告次要终点