Testing FoodTraining (FoodT): A Mobile App to Train Inhibitory Control Towards Food and Augment Standard Treatment for People With Eating and Weight Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Between-group differences (experimental vs. control group) in changes in tendency to eat in response to emotional eating
研究概览
简要总结
The aim of this project is to test the feasibility, acceptability and clinical impact of a mobile app-based intervention (FoodTraining) to strengthen food-related inhibitory control over 4 weeks, in a sample of people with eating or weight disorders (i.e. obesity, binge-eating disorder (BED), or bulimia nervosa (BN)) receiving standard outpatient treatment (i.e., treatment as usual (TAU) encompassing guided self-help or psychotherapy, pharmacological therapy or diet). The training will be offered in addition to TAU (experimental group) and compared to TAU alone (control group).
Participants will complete questionnaires to measure eating behaviour, eating disorder psychopathology, symptoms of anxiety, depression and stress, social functioning and quality of life at baseline, 4 and 8 weeks. They will also complete momentary assessments using a mobile application (FoodTracker) to report on food intake along with related thoughts, emotions, and behaviours and will wear small, non-invasive sensors to track real-time fluctuations in glucose levels for 15 days.
Participants will also perform a food-related go-no go task and a food-related temporal discounting task at baseline, 4 and 8 weeks.
Finally, this study will pilot the use of a semi-structured interview to characterise the history of weight, the appetite system, eating-related habits in the family and learning of eating behaviours and attitudes in people with eating or weight disorders.
详细描述
The study aims:
- To establish the feasibility, acceptability and clinical impact of a food-specific inhibitory control training delivered through a mobile App (i.e., FoodTraining) over 4 weeks in a sample of patients with obesity, bulimia nervosa or binge-eating disorder (N = 113) offered in addition to TAU, compared to TAU alone;
- To test the acceptability and adherence to the ecological momentary assessments collected through the Food Tracker App and the sensors for glucose monitoring;
- To characterise history of weight, appetite system, eating-related habits in the family and learning of eating behaviours and attitudes in people with obesity presenting for weight loss treatment.
An a-priori power analysis performed on the G*Power software, indicated that 93 participants would be needed to detect a significant 2 (group) x 3 (time) within-between interaction effect on the primary outcome measure (emotional eating and uncontrolled eating) with a small to medium effect size (Cohen's f = 0.15), a statistical power of 1-β = .80, and at a significant level α = .05, assuming a correlation among repeated measures of r = .5. To account for possible drop-out, the number will be exceeded by 20%. The final sample size that will be recruited is 113 participants.
Patients will be recruited and assessed at baseline, 4 and 8 weeks follow-up from the University Hospital in Padova (i.e., Eating Disorders Unit and Obesity Management Unit).
Assessment phase
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)
盲法说明
Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The outcome assessors will be blind to whether participants will be assigned to the experimental or control group.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI in the obesity range (>30) or a clinician-formulated diagnosis of binge eating disorder or bulimia nervosa;
- •knowledge of Italian or English;
- •access to a mobile device (e.g. smartphone, tablet).
排除标准
- •visual impairment not corrected by glasses
- •a diagnosis of psychosis;
- •intellectual disability.
研究组 & 干预措施
Experimental Condition (TAU + FoodTraining)
Participants in the experimental condition will be asked to perform a food-specific inhibitory control training delivered through the FoodTraining App once a day for the first week and three times a week for the remaining three weeks, for five minutes each time.
干预措施: Food-specific inhibitory control training delivered through the FoodTraining App (Behavioral)
Control condition
Participants in the control group will be offered access to the FoodTraining App at the end of the 8-week follow-up.
干预措施: Waiting list (Behavioral)
结局指标
主要结局
Between-group differences (experimental vs. control group) in changes in tendency to eat in response to emotional eating
时间窗: baseline; 4-, and 8- week follow-up
Emotional eating subscale of the Dutch Eating Behavior Questionnaire (DEBQ). Higher scores indicate a greater tendency to eat in response to internal emotional factors. Sum and mean of the scores for each subscale item: 1-2 = low level of that eating behaviour; 3 = medium level; 4-5 = high level.
Between-group differences (experimental vs. control group) in changes in uncontrolled eating behaviours
时间窗: baseline; 4-, and 8- weeks follow-up
Uncontrolled Eating subscale of the Three-Factor Eating Questionnaire (TFEQ). Higher scores indicate greater levels of the behaviour (Cognitive Restraint = 0-21; Uncontrolled Eating = 0-16; Emotional Eating = 0-14).
次要结局
- Between-group differences (experimental vs. control group) in urge to eat high calorie dense foods(baseline; 4-, and 8- weeks follow-up)
- Between-group differences (experimental vs. control group) in changes in eating disorder psychopathology(baseline; 4-, and 8- weeks follow-up)
- Between-group differences (experimental vs. control group) in changes in frequency and severity of binge eating episodes(baseline; 4-, and 8- week follow-up)
- Between-group differences (experimental vs. control group) in liking of high calorie dense foods(baseline; 4-, and 8- weeks follow-up)
- Between-group differences (experimental vs. control group) in food-related inhibitory control level(baseline; 4-, and 8- weeks follow-up)
- Between-group differences (experimental vs. control group) in changes in anxiety, stress and depression symptoms(baseline; 4-, and 8- weeks follow-up)
- Between-group differences (experimental vs. control group) in changes in social adjustment levels(baseline; 4-, and 8- weeks follow-up)
- Between-group differences (experimental vs. control group) in wanting of high calorie dense foods(baseline; 4-, and 8- weeks follow-up)
- Impact of impulsivity on the degree of changes in eating in response to internal emotional factors in the experimental and control groups(baseline)
- Between-group differences (experimental vs. control group) in changes in preference for immediate food rewards as compared to money(baseline; 4-, and 8- weeks follow-up)
- Between-group differences (experimental vs. control group) in changes in food craving(baseline; 4-, and 8- weeks follow-up)
- Between-group differences (experimental vs. control group) in food-related unpleasant emotions(3-day evaluation at baseline, repeated at 4-, and 8- weeks follow-up)
- Acceptability and adherence of the EMA assessments (FoodTracker)(8- weeks follow-up)
- Acceptability and adherence to glucose monitoring assessments(8- weeks follow-up)
- Impact of food addiction on the degree of changes in response to internal emotional factors in the experimental and control groups(baseline)
- Impact of food addiction on the degree of changes in uncontrolled eating in the experimental and control groups(baseline)
- Impact of impulsivity on the degree of changes in uncontrolled eating in the experimental and control groups(baseline)
- Adherence to the intervention (FoodTraining)(4 weeks follow-up)
- Feasibility of the intervention (FoodTraining)(8- weeks follow-up)
- Acceptability of the intervention (FoodTraining)(8- weeks follow-up)
研究者
CARDI VALENTINA
Professor
University of Padova