Overview

This trial is active, not recruiting.

Condition food cravings
Treatment mobile application intervention (device: smartphone)
Sponsor University of California, San Francisco
Start date February 2016
End date July 2016
Trial size 104 participants
Trial identifier NCT02694731, 15-17250

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants receive a mobile app with a 5-week mindful eating program and ongoing tools for coping with cravings
mobile application intervention (device: smartphone)
Consists of the app described in the arm description.

Primary Outcomes

Measure
Craving indulgence frequency
time frame: 1 month post-intervention

Secondary Outcomes

Measure
Craving indulgence frequency
time frame: 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)
time frame: 1 month post-intervention
Reward-based Eating Drive (RED)
time frame: immediate post-intervention (within 7 days of completing the intervention)
Palatable Eating Motives Scale, coping subscale
time frame: 1 month post-intervention
Palatable Eating Motives Scale, coping subscale
time frame: Immediate post-intervention (within 7 days of completing the intervention)
Food Cravings Questionnaire (FCQ-T-R)
time frame: 1 month post-intervention
Food Cravings Questionnaire (FCQ-T-R)
time frame: Immediate post-intervention (within 7 days of completing the intervention)

Eligibility Criteria

Female participants at least 18 years old.

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).

Additional Information

Official title A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings
Principal investigator Ashley E Mason, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.