A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

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.

• Mobile application intervention (Device: Smartphone) (Behavioral): Consists of the app described in the arm description.

Primary outcomes

• Craving indulgence frequency [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

• 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)]: 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
• Reward-based Eating Drive (RED) [1 month post-intervention]: Questionnaire measure of drive to eat for hedonic properties of food
• 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
• Palatable Eating Motives Scale, coping subscale [1 month post-intervention]: Questionnaire measure of drive to eat for coping
• Palatable Eating Motives Scale, coping subscale [Immediate post-intervention (within 7 days of completing the intervention)]: Questionnaire measure of drive to eat for coping
• Food Cravings Questionnaire (FCQ-T-R) [1 month post-intervention]: Questionnaire measure of food cravings
• Food Cravings Questionnaire (FCQ-T-R) [Immediate post-intervention (within 7 days of completing the intervention)]: Questionnaire measure of food cravings

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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).

• Wansink B. Environmental factors that increase the food intake and consumption volume of unknowing consumers. Annu Rev Nutr. 2004;24:455-79. doi: 10.1146/annurev.nutr.24.012003.132140. PMID 15189128
• Gendall KA, Joyce PR, Sullivan PF. Impact of definition on prevalence of food cravings in a random sample of young women. Appetite. 1997 Feb;28(1):63-72. doi: 10.1006/appe.1996.0060. PMID 9134095
• Epel ES, Tomiyama AJ, Mason AE, Laraia BA, Hartman W, Ready K, Acree M, Adam TC, St Jeor S, Kessler D. The reward-based eating drive scale: a self-report index of reward-based eating. PLoS One. 2014 Jun 30;9(6):e101350. doi: 10.1371/journal.pone.0101350. eCollection 2014. PMID 24979216
• Results publication: Sagui-Henson SJ, Radin RM, Jhaveri K, Brewer JA, Cohn M, Hartogensis W, Mason AE. Negative Mood and Food Craving Strength Among Women with Overweight: Implications for Targeting Mechanisms Using a Mindful Eating Intervention. Mindfulness (N Y). 2021;12(12):2997-3010. doi: 10.1007/s12671-021-01760-z. Epub 2021 Sep 24. PMID 34584574
• Results publication: Mason AE, Jhaveri K, Cohn M, Brewer JA. Testing a mobile mindful eating intervention targeting craving-related eating: feasibility and proof of concept. J Behav Med. 2018 Apr;41(2):160-173. doi: 10.1007/s10865-017-9884-5. Epub 2017 Sep 16. PMID 28918456

• Ashley E Mason, PhD, Principal investigator, University of California, San Francisco