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Clinical Trials/NCT02694731
NCT02694731
Completed
Not Applicable

A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

University of California, San Francisco1 site in 1 country104 target enrollmentFebruary 2016
ConditionsFood Cravings

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Food Cravings
Sponsor
University of California, San Francisco
Enrollment
104
Locations
1
Primary Endpoint
Craving indulgence frequency
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
November 30, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Craving indulgence frequency

Time Frame: 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

Secondary Outcomes

  • 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))

Study Sites (1)

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