Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- Child age and sex adjusted body mass index z-score (BMIz)
研究概览
简要总结
The objective of this proposed study is to compare Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education and reducing energy intake (ROC+) and a health education comparator (HE) for children with overweight or obesity who are high on food responsiveness (FR).
详细描述
The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that FBT has merit for some children, but not all, this study will compare ROC to FBT, ROC with nutrition education and reducing energy intake (ROC+), and Health Education (HE). Treatment will consist of weekly individual sessions for the first 16 sessions, then twice per month for the final 2 months for a total of 20 sessions. The investigators will recruit children ages 7-12 with overweight or obesity who are high in food responsiveness (FR) and their parent and will conduct assessments at baseline, post-treatment (month 6), 6-month follow-up (month 12) and 12-month follow-up (month 18).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed assent and parental consent
- •A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age
- •Child high on FR - High FR will be measured by the Food Responsiveness Scale via the CEBQ, with scores at a 3.8 or higher constituting a child with high FR.
- •A parent responsible for food preparation who is willing to participate and can read, speak and understand English at a minimum of a 5th grade level
- •Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments
- •Child is on stable medication regimen for medications that can impact weight (3+ months)
- •Child does not have medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity with their child or provide opportunities for the child to complete recommended physical activity
排除标准
- •Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
- •Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and exercise prescription may be warranted
- •Child who is taking medication for weight loss
- •Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
- •First degree relative or someone in the household with anorexia or bulimia nervosa.
- •Potential participants with medical or psychological diagnosis that could make adherence with the study protocol difficult or dangerous will not be included.
结局指标
主要结局
Child age and sex adjusted body mass index z-score (BMIz)
时间窗: Change from baseline at 3 months, 6 months, 12 months, and 18 months
Age and sex adjusted body mass index (BMI (kg/m\^2)) z-score based on the Centers for for Disease Control and Prevention (CDC) norms
Child percentage of the 95th percentile BMI (%BMIp95)
时间窗: Change from baseline 3 months, 6 months, 12 months, and 18 months
Age and Sex specific percentage of the 95th percentile BMI
Change in Child Overeating
时间窗: Change from baseline at 6 months,12 months, and 18 months
Measured by The Eating in the Absence of Hunger Questionnaire; Scores ranging from 1-5 with greater scores meaning more eating in the absence of hunger.
次要结局
- Child Food Cue Responsiveness as measured by the Child Eating Behavior Questionnaire(Change from baseline at 6 months,12 months, and 18 months])
- Parent Inhibition as measured by the Stop Signal Task(Change from baseline at 6 months,12 months, and 18 months)
- Child Food Cue Responsiveness as measured during exposure to a preferred food(Change from baseline at 6 months,12 months, and 18 months)
- Child Satiety Responsiveness as measured by the Child Eating Behavior Questionnaire(Change from baseline at 6 months,12 months, and 18 months)
- Child Satiety Responsiveness as measured by the Water Load Task (WLT)(Change from baseline at 6 months,12 months, and 18 months)
- Child Inhibition as measured by the Stop Signal Task(Change from baseline at 6 months,12 months, and 18 months)
- Child Inhibition as measured by the Go No Go (GNG) Task(Change from baseline at 6 months,12 months, and 18 months)
- Child Energy Intake(Change from baseline at 6 months,12 months, and 18 months)
- Parent Body Mass Index (BMI)(Change from baseline at 3 months, 6 months,12 months, and 18 months)
- Parent Overeating(Change from baseline at 6 months,12 months, and 18 months)
- Parent Food Cue Responsiveness as measured by the Adult Eating Behavior Questionnaire(Change from baseline at 6 months,12 months, and 18 months)
- Parent Food Cue Responsiveness as measured during exposure to a preferred food(Change from baseline at 6 months,12 months, and 18 months])
- Parent Satiety Responsiveness as measured by the Adult Eating Behavior Questionnaire(Change from baseline at 6 months,12 months, and 18 months)
- Parent Satiety Responsiveness as measured by the Water Load Task(Change from baseline at 6 months,12 months, and 18 months)
- Parent Inhibition as measured by the Go No Go (GNG) Task(Change from baseline at 6 months,12 months, and 18 months)
- Parent Energy Intake(Change from baseline at 6 months,12 months, and 18 months)
研究者
Kerri Boutelle
Kerri Boutelle, Ph.D.,, Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science
University of California, San Diego