Healthy Start to Feeding Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Appetite Regulation
研究概览
简要总结
The current study will test the impact of a 3-session obesity prevention program targeting healthy introduction of solid foods in infancy on growth trajectories, appetite regulation, and diet. The investigators will also test the feasibility and family satisfaction with the treatment. Healthy infants with normal and elevated weight-for-length will be enrolled in the study at 3 months of age and complete an initial study visit to assess baseline anthropometrics,demographics, parental feeding practices and beliefs, and infant appetite. Infants will than be randomly assigned to either the treatment condition (n = 20) or control condition (n = 20). Infants in the control condition will receive no intervention or further contact with the study team besides for completion of a final study assessment visit when the child is 9 months old. Infants in the treatment condition will receive a 3 session intervention targeting healthy introduction of solid foods, with study visits occurring when the child is 4 months, 6 months, and 9 months old. All families will complete a final study visit to complete post-treatment period measurements, which will include infant anthropometrics and parent-report of infant appetite, infant diet, and parental feeding practices and beliefs. Outcomes include: weight-for-length percentile, infant satiety responsiveness, infant food responsiveness, and infant fruit and vegetable consumption. Family satisfaction and treatment attendance will also be assessed.
详细描述
The purpose of this research study is to pilot test a prevention program to promote healthy introduction of solid foods and healthy weight gain among infants. Introduction of complementary foods (i.e., foods besides formula or breast milk) represents a major dietary milestone for infants. The current study will test the feasibility of a 3-session intervention encouraging healthy introduction of complementary foods and use of a responsive feeding approach. Feasibility of the intervention and the impact of the Healthy Start to Feeding (HSF) intervention on obesity risk factors and growth will be explored. This will be achieved through exploration of the following aims and hypotheses:
Aim 1: Determine feasibility of the intervention and family satisfaction with the treatment.
H1: Families assigned to the intervention condition will attend equal to or greater than 67% of treatment sessions.
H2: Families receiving the intervention will rate the program as helpful and consistent with the families' needs and priorities.
Aim 2: Test the impact of the HSF intervention on growth trajectories, appetite regulation, and diet at post-treatment.
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
- None
入排标准
- 年龄范围
- 3 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant aged 2-3 months at study recruitment
- •Infant not previously introduced to complementary foods (i.e., any food besides formula or breastmilk)
- •Infant born at > 38 weeks gestation
- •Infant weight-for-length > 10th percentile
- •Parent is fluent English speaker
排除标准
- •Known infant developmental delay
- •Impaired infant fine or gross motor skills
- •Condition currently impacting the infant's feeding and eating
结局指标
主要结局
Appetite Regulation
时间窗: The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).
Infant satiety and food responsiveness was measured using the parent-report Baby Eating Behavior Questionnaire (BEBQ). The BEBQ provides subscale scores for "Food Responsiveness", "Enjoyment of Food", "Satiety Responsiveness", and "Slowness in Eating" with each subscale score ranging from 1 to 5, with 5 representing higher values on that construct. Each subscale score is computed as the average of all individual items on that subscales.
Weight-for-Length Percentile
时间窗: Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).
Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.
Fruit and Vegetable Variety
时间窗: The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).
Fruit and vegetable variety was assessed using the parent-report Block Food Frequency Questionnaire. Scores were calculated for servings of vegetables per day and servings of fruits per day. The minimum value is 0. There is no upper-bound for the maximum value, as this is dependent on the individual participant's food consumption. Higher numbers indicate greater consumption. Only post-treatment results are presented since infants had not been introduced to solid foods at the time of baseline.
次要结局
- Family Satisfaction - Defined as Appropriateness of the Intervention Content and Session Timing, Clarity of Information, Knowledge of the Recommendations, Helpfulness, and Whether They Would Recommend the Intervention to Others.(The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).)
- Treatment Attendance(Attendance of sessions at study month 2 (session 1), study month 4 (session 2), and study month 7 (session 3) was recorded. The number of sessions that each participant attended was calculated.)
研究者
Cathy Stough
Assistant Professor
University of Cincinnati