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临床试验/NCT04177472
NCT04177472进行中(未招募)不适用

MAGIC: A Family Based Feeding Intervention Program

University of Texas at Austin4 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2019年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
165
试验地点
4
主要终点
BMI percentile at 12 months of age

研究概览

简要总结

The incidence of childhood obesity in the United States has steadily increased over the past 30 years but has begun to level off in recent years. Epidemiological evidence indicates that obesity may transmitted across multiple generations. The current study seeks to: 1) evaluate the extent to which mothers and other important caregivers affect their mothers' parenting; 2) examine whether an intervention aimed at improving diet quality and enhancing responsive feeding to improves parental responsivity and feeding behavior and infants' weight trajectories over time; 3) examine the effects of early life feeding and caregiver sensitivity on health and development; and 4) examine feasibility of food distribution along with the feeding intervention.

详细描述

The incidence of childhood obesity in the United States has steadily increased over the past 30 years, but has begun to level off in recent years. Children from minority groups may be disproportionately affected, such that Hispanic and non-Hispanic Black children have greater weight for recumbent length compared to White children. Similarly, socioeconomic status (SES) may affect child weight status. Epidemiological evidence indicates that obesity may transmitted across multiple generations. Genetics are a factor in determining weight status, but parents are largely responsible for regulating children's dietary environments. Grandparents increasingly provide care for their grandchildren, yet few studies have examined grandparent involvement or the role that grandparents or other significant caregivers play in feeding the child.

The objective of the current study is two-fold: 1) to evaluate the extent to which mothers and other caregivers affect mothers' parenting surrounding feeding their infant, beginning when the infant is first introduced to solid foods; and 2) to examine whether an intervention aimed at providing both mothers and and other important caregivers with hands-on training regarding healthy foods and responsive and sensitive feeding behaviors improves mothers' and other caregivers' responsive and sensitive behaviors and infants' weight trajectories over time. The researchers will collect both self-report data on diet, child temperament, mothers and caregiver mental health, stress and support. Observational assessments will be obtained to code co-caregiver behavior and caregiver responsiveness during feeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Primary - BMI percentile at 12 months of age, and 24 months of age

Secondary- Proportion of infants with BMI percentile >85th at 12 months of age, and 24 months of age

Anthropometrics measured directly by trained study staff

Infant dietary intake of fruits and vegetables, animal source foods, whole grains, desserts and sweets, and salty snacks at 10 to 11 months.

Measured at 10 months using an Infant Diet History questionnaire adapted from the Infant Feeding Practices Study II. Measured at 10 months using the Nutrition Data System for Research (NDSR)

Responsive feeding measured using the Infant Feeding Styles Questionnaire (IFSQ) full scale and Chatoor's feeding scale at 10 to 11 months.

入排标准

年龄范围
0 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mothers with babies aged 4 to 5 months
  • Other caregivers assisting the mother with the baby.
  • Babies aged 4 to 5 months

排除标准

  • Babies with metabolic or feeding issues.
  • Mothers younger than 16 years of age.

研究组 & 干预措施

Obesity Prevention Group

Experimental

Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options.

干预措施: Obesity Prevention Group (Behavioral)

Infant Safety and Injury Prevention Group

Active Comparator

Parents will be provided with information about safe sleeping, car seats, baby-proofing, etc., delivered during virtual visits, participant binder and newsletter.

干预措施: Infant Safety and Injury Prevention Group (Behavioral)

Obesity Prevention Group + Food Boxes

Experimental

Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options. Parents will also be provided with grocery items (fruits, vegetables, meat) prior to each intervention visit to facilitate a healthy family diet.

干预措施: Obesity Prevention Group + Food Boxes (Behavioral)

结局指标

主要结局

BMI percentile at 12 months of age

时间窗: 12 months

Anthropometrics measured by trained study staff

BMI percentile at 24 months of age

时间窗: 24 months

Anthropometrics measured by trained study staff

次要结局

  • Proportion of infants with BMI percentile >85th at 12 months of age(12 months)
  • Proportion of infants with BMI percentile >85th at 24 months of age(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah Jacobvitz

Phyllis L. Richards Endowed Professor in Child Development

University of Texas at Austin

研究点 (4)

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