RCT Testing the Effectiveness of an Early Obesity Prevention Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- Reduction in the prevalence and degree of obesity at age 3 years
研究概览
简要总结
The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.
The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.
Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices
详细描述
Expected outcomes include: (1) Reduction in the prevalence and degree of obesity. (2) Improvement in child diet composition. (3) Improvement in parent feeding knowledge, attitudes, styles and practices including. (4) Improvement in lifestyle behaviors, such as sleep, screen time and physical activity, associated with increased risk of obesity. (5) Improvement in parent diet.
Our secondary objective is to understand the mechanisms by which changes in parent knowledge and behavioral factors mediate impacts of the intervention on childhood obesity. We will also study relationships between potential moderators and intervention impacts. The new components of the expanded Starting Early Program will be feasible: Families will participate in the preschool intervention, and pregnant women will enroll in the prenatal intervention.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Latina mother > 18 years with singleton uncomplicated pregnancy
- •Receiving prenatal care and the intention to receive pediatric care at Bellevue Hospital Center or Gouverneur Healthcare Services
- •Mother to be primary caregiver of child
- •Mother speaks fluent English or Spanish
排除标准
- •Maternal history of serious medical or psychiatric illness or drug or alcohol abuse
- •Family does not have a phone
- •Infants with severe medical problems that may affect feeding
结局指标
主要结局
Reduction in the prevalence and degree of obesity at age 3 years
时间窗: 3 years
Continuous and dichotomized measures (BMI percentiles)
Improvement in infant diet composition
时间窗: 1-3 years
Diets of intervention group infants and children will be more likely to follow recommended guidelines including: i) Increased breastfeeding rates and duration ii) Appropriate timing of introduction to solids iii) Appropriate timing of bottle weaning iv) Increased fruit and vegetable consumption v) Decreased fast and junk food consumption vi) Decreased sugary beverage consumption vii) Age-appropriate portion sizes
Participant engagement
时间窗: 2-5 years
Proportion of enrolled mother-infant dyads that participate in the different aspects of the program. This will include the number of individual sessions with healthy steps, the number of individual sessions with the health educator, the number and type of referrals to community resources provided, and the number of Nutrition and Parenting Support Groups attended. This will enable us to determine the length of engagement in the program, proportion of enrolled mother-infant dyads that complete each study measure
Improvement in infant lifestyle behaviors associated with increased risk of obesity.
时间窗: 1-3 years
Measures of lifestyle behaviors among infants and children receiving intervention will be more likely to follow recommended guidelines than those of the control group including: i) Better sleep habits ii) Reduced screen time iii) Increased physical activity
Reduction in infant and child excess weight gain
时间窗: 1-3 years
Continuous anthropometric measures (weight for length z-scores)
Feasibility process measures:
时间窗: 2-5 years
Study population eligibility and enrollment, Proportion of pregnant women approached who meet eligibility criteria, Proportion of women meeting eligibility criteria who enroll These proportions will be calculated using study recruitment records.
Improvement in parent feeding knowledge, attitudes, styles and practices
时间窗: 1-3 years
Parent feeding knowledge, attitudes, styles and practices in the intervention group will be healthier than those of the control group including: i) Awareness of healthy child weight ii) Improved knowledge of optimal feeding practices iii) More responsive feeding style
Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention
时间窗: 2-5 years
Will be feasible, intervention mothers will have improved nutrition knowledge, and feeding attitudes, styles and behaviors
Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention
时间窗: 2-5 years
Will be feasible, ii) intervention women will have improved nutrition knowledge and behaviors, iii) intervention women will have improved gestational weight gain
Participant satisfaction
时间窗: 2-5 years
We will assess program satisfaction
次要结局
未报告次要终点