Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism: A Natural History Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To determine whether an association exists between unpredictability schema measures and ad libitum food intake.
研究概览
简要总结
Background:
Many people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults.
Objective:
To explore how childhood experiences affect adult eating behaviors.
Eligibility:
Healthy people aged 18 to 60 years.
Design:
Participants will have 3 clinic visits.
They will be screened with blood tests. They will answer questions about their alcohol and tobacco use.
At the next visit, participants will undergo these activities:
Parts of their body (such as waist, neck, and thighs) will be measured with a tape.
They will have an imaging scan to find out how much body fat they have.
They will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days.
They will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days.
They will answer questions about their education, childhood, and routines.
They will receive a kit to collect a stool sample at home.
At the last visit, participants will have these tests:
Participants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head.
Blood samples will be taken before and after participants drink a sugary drink.
Participants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.
详细描述
Study Description:
The unpredictability schema - "a pervasive belief that other people cannot be trusted and future outcomes cannot be predicted or controlled" - has been hypothesized to (1) be shaped by parental/household dynamics and (2) impact appetitive and consumptive behaviors. However, studies on appetitive behaviors were mostly based on self-report and to our knowledge, no studies have examined objective measurements of energy intake or expenditure in association with unpredictability. Therefore, the current study seeks to examine whether the unpredictability schema as measured by a composite score of unpredictability assessments is associated with ad libitum food consumption and eating in the absence of hunger, measured objectively. Furthermore, we will examine the associations between the unpredictability schema and physical activity, resting metabolic rate/respiratory quotient, and glucose trajectories during an oral glucose tolerant test and continuous glucose monitoring in a cohort of healthy participants.
Objectives:
Primary Objective:
- To determine whether an association exists between unpredictability schema measures (schema/beliefs and childhood experiences as measured by derived from the Child Unpredictability Index, Scale of Unpredictability Beliefs, Unpredictability Schema Scale, and Confusion, Hubbub, and Order Scale and, individually, by scale totals and subscales) and ad libitum food intake.
- To determine whether an association exists between the unpredictability schema and experience scores and eating in the absence of hunger (as determined by the snack food taste test).
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- 18-60 years of age.
- Able to read and understand English proficiently (to be able to complete the multiple study questionnaires and instruments).
排除标准
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diabetes
- Fasting glucose >= 126 mg/dl or HbA1c >= 6.5% or
- Self-reported history of type 1 or type 2 diabetes.
- Endocrine disorders, such as --Self-reported history of Cushing's disease, pituitary disorders, or hypo- and hyperthyroidism
- TSH <=0.27 or >= 10 uIU/mL
- Pulmonary disorders --Self-reported history of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)
- Cardiovascular diseases, --Self-reported history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol (investigator judgment)
- Liver disease,
- Advanced liver disease (as determined by history, labs, exams, and patient self-report) that which would limit ability to follow the protocol (investigator judgment)
- AST or ALT elevations > 3 times upper limit of normal
- Gastrointestinal Surgery --Self-reported history of bariatric surgery
- Renal disease
- Self-reported history of renal replacement therapy
- Abnormal kidney function (defined as eGFR <60 mL/min/1.73m^2) determined at screening (eGFR values are computed using the 2021 CKD-epi equation)
- Central nervous system disease: --Including self-reported history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Infectious disease: --Self-reported history of active tuberculosis, HIV, chronic coccidiomycosis or other chronic or acute infections
- For Females: pregnancy, <=6 months postpartum, currently breastfeeding, or on birth control (i.e., ingested, injected or implanted; non-hormonal methods such as copper IUD will be allowed)
- Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer)
- Inability to provide informed consent.
- Self-reported history of psychological conditions including (but not limited to), active psychosis, schizophrenia, eating disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study.
- Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism.
- Inability to consume provided food during ad libitum food intake or snack food test based on a food allergy or intolerances or diet restrictions.
- Any disorder not covered by any other exclusion criteria which, in the investigator's and/or team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol.
- Alcohol Abuse as defined by >= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire will be an exclusion criterion.
- Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2) will be an exclusion criterion.
- Non-English-speaking subjects as a population will be excluded from participation in this protocol. Primary and secondary hypotheses of the protocol relate to a battery of psychological questionnaires and performances tests which are administered throughout the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore, we will restrict enrollment to English speaking subjects only.
研究组 & 干预措施
Healthy Volunteer
adults, age 18-60 years
结局指标
主要结局
To determine whether an association exists between unpredictability schema measures and ad libitum food intake.
时间窗: Day 10
Ad libitum Food Intake (kcal) measured from a buffet meal task.
To determine whether an association exists between the unpredictability schema and experience scores and eating in the absence of hunger
时间窗: Day 10
Eating in the absence of hunger (kcal) from a snack food taste test.
次要结局
- To determine whether an association exists between measures of the unpredictability schema and experience scores with county-level food swamp statistics (i.e., Retail Food Environment Index).(Day 10)
- To determine whether an association exists between the unpredictability schema and experience scores and self-reported appetitive eating traits and behavior(Day 10)
- To determine whether an association exists between measures of the unpredictability schema and experience scores and physical activity.(Day 10)
- To determine whether an association exists between measures of the unpredictability schema and experience scores and resting metabolic rate and RQ.(Day 10)
- To determine whether an association exists between measures of the unpredictability schema and experience scores and glucose values (CGM and OGTT)(Day 10)
- To determine whether an association exists between measures of the unpredictability schema and experience scores and telomere length(Day 10)
- To determine whether an association exists between measures of the unpredictability schema and experience scores and with gut microbiota composition.(Day 10)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06690294
- 其他研究编号
- 10001980, 001980-DK
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (4个月后)
- 研究完成日期
- (4个月后)
- 最近核实
- (13天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否