A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

NCT02694731 | Completed

• 1 other identifier: 15-17250
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Cravings

Keywords

Craving; Mobile Apps

Outcome Measures

Primary Outcomes (1)

• Craving indulgence frequency

  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

  1 month post-intervention

Secondary Outcomes (7)

• 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)

• Reward-based Eating Drive (RED)

  1 month post-intervention

• Reward-based Eating Drive (RED)

  immediate post-intervention (within 7 days of completing the intervention)

• Palatable Eating Motives Scale, coping subscale

  1 month post-intervention

• Palatable Eating Motives Scale, coping subscale

  Immediate post-intervention (within 7 days of completing the intervention)

Study Arms (1)

Mobile application intervention

EXPERIMENTAL

Participants receive a mobile app with a 5-week mindful eating program and ongoing tools for coping with cravings

Behavioral: Mobile application intervention (Device: Smartphone)

Interventions

Mobile application intervention (Device: Smartphone) BEHAVIORAL

Consists of the app described in the arm description.

Mobile application intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

• 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 DERIVED

Study Officials

• Ashley E Mason, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: February 29, 2016
• Study Start: February 1, 2016
• Primary Completion: November 29, 2016
• Study Completion: November 30, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)