SPOON: Sustained Program for Improving Nutrition - Colombia
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 主要终点
- Change in Height and Weight from 8 months old to 10 months old
研究概览
简要总结
The primary goal of this study is to prevent undernutrition and obesity in peri-urban areas of Colombia. This study is designed to evaluate the impact of promoting adequate feeding practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the nutritional status of infants and young children. The study will be conducted in peri-urban areas of Pasto, Colombia in conjunction with Fundación Saldarriaga Concha and the Colombian Ministry of Health and Social Protection.
详细描述
SPOON Colombia is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in high-poverty areas of Colombia. The SPOON program aims to improve infant and young children feeding practices, including exclusive breastfeeding during a child's first six months and home-fortification with peanut-based SQ-LNS (small quantity lipid-based nutrient supplements) for children 6 to 24 months of age.
The SPOON intervention will randomly assign participants at the household level to one of three groups: a control group, Treatment Group 1, and Treatment Group 2. Participants in the control group will receive the standard services provided by their local health clinics in addition to a supply of micronutrient powder. The powder consists of vitamins and minerals that are added to the child's food to increase his or her consumption of micronutrients. Participants in Treatment Group 1 will receive group counseling and the SQ-LNS supplement instead of micronutrient powder. The group counseling program consists of various lessons for the children's caregivers about the importance of breastfeeding and providing high quality food with the SQ-LNS supplement. Those assigned to Treatment Group 2 will receive all the services that those in Treatment Group 1 receive in addition to individualized counseling, where messages about nutrition and breastfeeding will be reinforced through home visits.
Comparing the three treatment arms will identify the marginal impact of the SPOON program. For example, measuring the differences in outcomes between the participants in the control arm and in Treatment Group 1 will identify the impact of the Spoon program package, which includes SQ-LNS and group counseling, compared to current government-provided services. Measuring the differences between Treatment Group 1 and Treatment Group 2 will indicate the marginal impact of individualized counseling, and measuring the difference between the control arm and Treatment Group 2 will determine the combined impact of the SPOON program combined with individualized counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must live in the defined intervention areas
排除标准
- •Any chronic disease or malformation
- •Caretakers of the children plan on moving in the next 24 months
研究组 & 干预措施
Standard Counseling and Micronutrients
Participants will receive standard services provided by the Ministry of Health, including powder micronutrients. Children receive 1 gram of powdered micronutrientes for 60 days between 6 and 12 months of age, and 60 daily packets per year from the time they are 1 year old until 5 years old.
干预措施: Micronutrients (Dietary Supplement)
Standard Counseling and Micronutrients
Participants will receive standard services provided by the Ministry of Health, including powder micronutrients. Children receive 1 gram of powdered micronutrientes for 60 days between 6 and 12 months of age, and 60 daily packets per year from the time they are 1 year old until 5 years old.
干预措施: Standard Counseling (Behavioral)
SPOON Group Counseling with SQ-LNS
Participants will receive the supplement SQ-LNS in addition to SPOON group counseling, which is a new form of social communication in which participants will learn relevant lessons in a group format. SQ-LNS consists of a 20g nutrient supplement package that is to be consumed daily between 6 and 24 months of age.
干预措施: SPOON Group Counseling (Behavioral)
SPOON Group Counseling with SQ-LNS
Participants will receive the supplement SQ-LNS in addition to SPOON group counseling, which is a new form of social communication in which participants will learn relevant lessons in a group format. SQ-LNS consists of a 20g nutrient supplement package that is to be consumed daily between 6 and 24 months of age.
干预措施: SQ-LNS (Dietary Supplement)
Group, Interpersonal Counseling, SQ-LNS
Participants will receive the supplement SQ-LNS in addition to SPOON group and interpersonal counseling, which will consist of both participants learning relevant lessons in group format as well as in formats in which participants will work one-on-one with an instructor. SQ-LNS consists of a 20g nutrient supplement package that is to be consumed daily between 6 and 24 months of age.
干预措施: SPOON Group Counseling (Behavioral)
Group, Interpersonal Counseling, SQ-LNS
Participants will receive the supplement SQ-LNS in addition to SPOON group and interpersonal counseling, which will consist of both participants learning relevant lessons in group format as well as in formats in which participants will work one-on-one with an instructor. SQ-LNS consists of a 20g nutrient supplement package that is to be consumed daily between 6 and 24 months of age.
干预措施: Interpersonal Counseling (Behavioral)
Group, Interpersonal Counseling, SQ-LNS
Participants will receive the supplement SQ-LNS in addition to SPOON group and interpersonal counseling, which will consist of both participants learning relevant lessons in group format as well as in formats in which participants will work one-on-one with an instructor. SQ-LNS consists of a 20g nutrient supplement package that is to be consumed daily between 6 and 24 months of age.
干预措施: SQ-LNS (Dietary Supplement)
结局指标
主要结局
Change in Height and Weight from 8 months old to 10 months old
时间窗: Measured when child is 8 months old and when child is 10 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 10 months old to 12 months old
时间窗: Measured when child is 10 months old and when child is 12 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 12 months old to 14 months old
时间窗: Measured when child is 12 months old and when child is 14 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 14 months old to 16 months old
时间窗: Measured when child is 14 months old and when child is 16 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 16 months old to 18 months old
时间窗: Measured when child is 16 months old and when child is 18 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 18 months old to 20 months old
时间窗: Measured when child is 18 months old and when child is 20 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 20 months old to 22 months old
时间窗: Measured when child is 20 months old and when child is 22 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 22 months old to 24 months old
时间窗: Measured when child is 22 months old and when child is 24 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from Baseline to 8 months old
时间窗: Measured when child is 6 months old at baseline and when child is 8 months old
Prevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
次要结局
- Change in Cephalic Circumference from Baseline(Measured when child is 6 months old and when child is 2 years old)
- Change in Eating Habits from Baseline(Measured when child is 6 months old and when child is 2 years old)
- Change in Health Status from Baseline(Measured when child is 6 months old and when child is 2 years old)
- Change in Measures of Caregiver Knowledge from Baseline(Measured when child is 6 months old and when child is 2 years old)
- Change in Prevalence of Anemia from Baseline(Measured when child is 6 months old and when child is 2 years old)
- Weight Gain Rate(Measured every 2 months when child is between 6 and 24 months old)