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临床试验/NCT04287764
NCT04287764已完成不适用

Repeatability of the Infant Food Reinforcement Paradigm: Implications of Individual and Developmental Differences

State University of New York at Buffalo0 个研究点目标入组 37 人开始时间: 2016年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
主要终点
FRR

研究概览

简要总结

The purpose of this study is to assess the test-retest reliability of an infant RRV paradigm which will allow researchers to study food reinforcement among infant of 9-18 months of age. By understanding the origins of food reinforcement, future interventions can be conducted to help overweight and obese population to alter their reinforcing values of food at a young age, perhaps during infancy.

详细描述

  1. Initial email or phone screen:

Upon receiving an inquiry from a prospective participant, the study will be explained. If the prospective participant has an infant age 9 to 18 months, and the caregiver is interested in joining the study, a verbal consent will be obtained in order to screen for eligibility criteria. The initial screening questionnaire could be done via phone or online via Survey Monkey (see Initial Phone Screen/Survey Monkey Questionnaire for details). The information assessed during the initial screen is recorded in a secure database that requires a password. The database is used by select members of the Division of Behavioral Medicine and has been approved for use by previous IRB committees.

Families will also be sent a list of links of questionnaires to be completed at home before the assessments. These questionnaires include the Demographic Questionnaire, Pregnancy History and Infant Feeding Practice Questionnaire, Food Security Questionnaire, Infant Behavior Questionnaires-Revised (IBQ-R), and Baby Eating Behavior Questionnaire (BEBQ). 2. Session 1:

If families meet the initial criteria gathered from the initial screen, families will be scheduled for a laboratory visit (40 min). For this visit, the caregiver will be advised to choose a time of the day when the infant is generally alert, active, and ready to play. The infant needs to be fed one hour prior to the lab visit. The caregiver will be reminded to bring diapers or change of clothes for the infant. The caregiver will also be reminded not to feed her infant the test food (infant's favorite food) 24 hours before the laboratory visit. At the first visit, there will be an overview of the study. If interested, the caregiver will be asked to review and sign consent forms. Two copies of the consent forms will be signed by all parties involved, person obtaining consent, and the participating parent. One copy will be obtained by the study personnel and one copy will be given to the participants for their records. The copy obtained by study personnel will be kept in a locked cabinet.

After signing the consent form, the caregiver and infant will be escorted to a laboratory room where the food reinforcement game will take place. At this visit, infant will play the first part of the RRV game. Infants will be securely fastened on a high chair. The caregiver will be in the room with the infant at all-time during the game. The caregiver will be reminded that the entire reinforcement task procedure will be video recorded to obtain vocalization, body movement, and facial expression of the infant. The baseline state of the infant will be assessed. There are five states: 1 = drowsy, 2 = alert/calm, 3 = alert/active, 4 = fussy, 5 = crying. Before the start of the game, a study staff member will go through a training session with the infant to familiarize him/her with the computer based game and button/monitor interface. The caregiver will be asked to assist with the training by repeating phrases the researchers use during the game. After the training, the study staff member will start the actual game.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
9 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant must be between the ages of 9 to 18 months old
  • Infant must appear to be healthy
  • Infant of singleton (i.e. not twin or multiple)
  • Infant not allergic to puffed grains or Original Cheerios

排除标准

  • Infant of pre-mature or pre-term birth (< 37 weeks of gestation)
  • Infant of low birth weight (<2500 grams)
  • Infant with medical problems at birth
  • Infant with developmental delay based on developmental milestones recorded at 6 or 9 month check up
  • Infant who has not eaten the test food due to allergy concern
  • Maternal age < 18 years
  • Mother who smoked, used controlled substances (i.e. opiates, cocaine, marijuana) or consumed excessive alcohol during pregnancy
  • Mother who had a high-risk pregnancy

结局指标

主要结局

FRR

时间窗: through study completion, an average of 1 year

The primary outcome is the reliability of the food reinforcing ratio.

次要结局

  • Weight status(through study completion, an average of 1 year)

研究者

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

Kai Ling Kong

Principal Investigator

State University of New York at Buffalo

相似试验

Infant Test-Retest of the Food Reinforcing Ratio Task | 临床试验