Clinical trial NCT02694731: A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings
Official title: A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Cravings
Keywords: Craving
Mobile Apps
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  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).

Primary outcomes:
measure: Craving indulgence frequency
timeFrame: 1 month post-intervention
Secondary outcomes:
measure: Craving indulgence frequency
timeFrame: 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)
measure: Reward-based Eating Drive (RED)
timeFrame: 1 month post-intervention
measure: Reward-based Eating Drive (RED)
timeFrame: immediate post-intervention (within 7 days of completing the intervention)
measure: Palatable Eating Motives Scale, coping subscale
timeFrame: 1 month post-intervention
measure: Palatable Eating Motives Scale, coping subscale
timeFrame: Immediate post-intervention (within 7 days of completing the intervention)
measure: Food Cravings Questionnaire (FCQ-T-R)
timeFrame: 1 month post-intervention
measure: Food Cravings Questionnaire (FCQ-T-R)
timeFrame: Immediate post-intervention (within 7 days of completing the intervention)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ashley E Mason, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.