Learning Theory to Improve Obesity Treatment (Intervention for Regulation of Cues)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months
研究概览
简要总结
The purpose of this study is to optimize an obesity treatment program targeting overweight 8-12 year old children using "Cue Exposure Training".
详细描述
The goal of the Cue Exposure program is to train children to resist cues to eat unhealthy foods. Through a series of experimental studies, the investigators will evaluate how many weekly treatment visits there should be, whether children should be exposed to a single food or multiple foods during treatment, whether to use partial reinforcement or not, whether visits should be daily or weekly, and whether the exposures should be in single or multiple contexts. The investigators will be recruiting parent-child dyads in the San Diego community to participate in 8 to 16 weekly or daily treatment sessions either in their home, community center, or our lab, depending on the treatment arm. Parents and children will complete baseline and post-treatment assessments consisting of collecting psychophysiological data, completing laboratory tasks, and completing questionnaires. The investigators will be evaluating which treatment condition reduces overeating (as measured by our laboratory tasks).
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
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Response to an advertisement for the study,
- •An overweight or obese child in the family who is between the ages of 8 and 13,
- •The 8-13 year old child must be above the 85th BMI % for age and gender,
- •Parent willing to participate and attend all meetings,
- •Parent who can read at a minimum of a 5th grade level in English,
- •Parent and child willing to commit to attendance and assessments,
- •Child who eats in the absence of hunger.
排除标准
- •Major child psychiatric disorder diagnoses,
- •An obese child over the 99.9th BMI %
- •Child or parent diagnoses of diabetes for which physician supervision of diet is needed or diagnosis of serious current physical diseases (such as cancer, multiple sclerosis, lupus) which could significantly decrease their ability to participate in the intervention (parent report),
- •Child taking a medication that can affect cognitive functioning, such as attention, concentration, or mental status.
- •Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home (these restrictions affect their ability participate in the food exposures because it would limit the variety of foods available to do exposures with),
- •Child with an active eating disorder (based on parent and child self-report)
- •Major parent psychiatric or eating disorder.
研究组 & 干预措施
Single context
Subjects will be exposed to food cues in a single context.
干预措施: Partial Reinforcement - Enhanced Cue Exposure Treatment (Behavioral)
Single context
Subjects will be exposed to food cues in a single context.
干预措施: Partial Reinforcement -Consistent Cue Exposure Treatment (Behavioral)
Multiple contexts
Subjects will be exposed to food cues in multiple contexts.
干预措施: Partial Reinforcement - Enhanced Cue Exposure Treatment (Behavioral)
Multiple contexts
Subjects will be exposed to food cues in multiple contexts.
干预措施: Partial Reinforcement -Consistent Cue Exposure Treatment (Behavioral)
8 treatment sessions
Subjects receive 8 treatment sessions.
干预措施: Single food Cue Exposure Treatment (Behavioral)
8 treatment sessions
Subjects receive 8 treatment sessions.
干预措施: Multiple food Cue Exposure Treatment (Behavioral)
16 treatment sessions
Subjects receive 16 treatment sessions
干预措施: Single food Cue Exposure Treatment (Behavioral)
16 treatment sessions
Subjects receive 16 treatment sessions
干预措施: Multiple food Cue Exposure Treatment (Behavioral)
结局指标
主要结局
Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months
时间窗: Change from baseline at an average of 3 months and 6 months
Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.
Change in child weight
时间窗: Change from baseline at an average of 3 and 6 months
BMI, BMIz
次要结局
- Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months(Change from baseline at average of 3 and 6 months)
- Change in attention to food cues from baseline at average of 3 and 6 months(Change from baseline at average of 3 and 6 months)
- Change in parent weight from baseline at average of 3 and 6 months(Change from baseline at average of 3 and 6 months)
- Change in impulsivity/Inhibition from baseline at average of 3 and 6 months(Change from baseline at average of 3 and 6 months)
- Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months(Change from baseline at average of 3 and 6 months)
研究者
Kerri Boutelle
Associate Professor
University of California, San Diego