A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

Conditions
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Food Cravings

Intervention / Treatment
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* Behavioral: Mobile application intervention (Device: Smartphone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile application intervention<br>Participants receive a mobile app with a 5-week mindful eating program and ongoing tools for coping with cravings | Behavioral: Mobile application intervention (Device: Smartphone)<br>* Consists of the app described in the arm description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving indulgence frequency | 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 | 1 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving indulgence frequency | 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 | 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) | 
| Reward-based Eating Drive (RED) | Questionnaire measure of drive to eat for hedonic properties of food | 1 month post-intervention | 
| Reward-based Eating Drive (RED) | Questionnaire measure of drive to eat for hedonic properties of food | immediate post-intervention (within 7 days of completing the intervention) | 
| Palatable Eating Motives Scale, coping subscale | Questionnaire measure of drive to eat for coping | 1 month post-intervention | 
| Palatable Eating Motives Scale, coping subscale | Questionnaire measure of drive to eat for coping | Immediate post-intervention (within 7 days of completing the intervention) | 
| Food Cravings Questionnaire (FCQ-T-R) | Questionnaire measure of food cravings | 1 month post-intervention | 
| Food Cravings Questionnaire (FCQ-T-R) | Questionnaire measure of food cravings | Immediate post-intervention (within 7 days of completing the intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craving, Mobile Apps