A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Craving indulgence frequency
研究概览
简要总结
Participants will complete a 5-week smartphone app-based intervention that teaches mindful eating skills. One goal is to determine to what extent participants will enjoy using the app and complete the intervention. The investigators predict that after completing the intervention, participants will report fewer episodes of eating in response to food cravings. The investigators will also measure several other biological and behavioral outcomes.
详细描述
In this prospective repeated-measures cohort study, participants will complete a 5-week smartphone app-based intervention that teaches mindful eating skills. The investigators will assess psychological and behavioral intervention targets using questionnaires and brief mobile assessments. The investigators will also measure BMI and adiposity. Assessments will occur at pre-intervention, post-intervention, and 1 and 2 months post intervention. At several times during the study, participants will also receive multiple daily text messages asking them to complete a brief food craving assessment on their phone. This "experience sampling" approach is critical as it allow the investigators to capture experiences and behaviors that are often brief and automatic, making them poorly suited to traditional retrospective questionnaires. The investigators will also assess acceptability and continued use of the app via anonymous usage logs.
Overall, the aims are to 1) assess feasibility of the protocol, 2) assess changes in food cravings and indulgence of cravings, and 3) determine the extent to which participants remain engaged with the app after completing the 5-week intervention period and whether this predicts maintenance of benefits at 1 month and 2 months post-intervention. An exploratory aim is to measure the effects of the intervention on body weight, bodyfat, and bodyfat distribution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Problems with controlling food intake as indexed by "yes" responses to the following two questions: "Do you have food cravings?" and "Do you eat in response to your food cravings more than you would like to?"
- •Overweight or obese (BMI of 25.0 to 39.9 kg/m2)
- •Score at or above the scale midpoint on the Readiness Ruler, a single-item visual analog scale measure of readiness for behavioral change (prompt is, "I have decided to give in to food cravings less")
- •Have and use a smartphone (Android or iOS) with internet access.
- •Report food cravings on most days and a desire to indulge in food cravings less
排除标准
- •Current diabetes
- •Pregnant or plans to become pregnant within 4 months
- •Current diagnosis of anorexia or bulimia
- •In the opinion of an investigator, meets any of the following criteria:
- •Likely to drop out due to expressed ambivalence or lack of interest
- •Likely to be harmed in any way by participating
- •Likely to have provided untruthful answers to the screening questions (based on evidence such as unclear or inconsistent responses when talking to study staff vs. reporting online, or log data showing repeated attempts to "game" the screening questionnaire).
结局指标
主要结局
Craving indulgence frequency
时间窗: 1 month post-intervention
Cell phone questionnaires assess frequency with which participants eat in response to food cravings. Cell phone questionnaires assess frequency with which participants eat in response to food cravings. Participants are asked whether they ate in response to a craving in the past hour
次要结局
- Palatable Eating Motives Scale, coping subscale(Immediate post-intervention (within 7 days of completing the intervention))
- Food Cravings Questionnaire (FCQ-T-R)(Immediate post-intervention (within 7 days of completing the intervention))
- Reward-based Eating Drive (RED)(immediate post-intervention (within 7 days of completing the intervention))
- Craving indulgence frequency(Administered 9 times over the 7 days after the participant completes the intervention (typically 28 days after beginning the study; may be longer if participant takes extra days to complete the intervention))