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A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

Not Applicable
Completed
Conditions
Food Cravings
Registration Number
NCT02694731
Lead Sponsor
University of California, San Francisco
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
104
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:

    1. Likely to drop out due to expressed ambivalence or lack of interest
    2. Likely to be harmed in any way by participating
    3. 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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Craving indulgence frequency1 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

Secondary Outcome Measures
NameTimeMethod
Palatable Eating Motives Scale, coping subscaleImmediate post-intervention (within 7 days of completing the intervention)

Questionnaire measure of drive to eat for coping

Food Cravings Questionnaire (FCQ-T-R)Immediate post-intervention (within 7 days of completing the intervention)

Questionnaire measure of food cravings

Reward-based Eating Drive (RED)immediate post-intervention (within 7 days of completing the intervention)

Questionnaire measure of drive to eat for hedonic properties of food

Craving indulgence frequencyAdministered 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)

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

Trial Locations

Locations (1)

University of California San Francisco

🇺🇸

San Francisco, California, United States

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