A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

Food Cravings Clinical Trial

Official title:

A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694731
• Other study ID #: 15-17250
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: May 5, 2017
• Start date: February 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: May 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 30, 2016
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Food Cravings

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Wansink B. Environmental factors that increase the food intake and consumption volume of unknowing consumers. Annu Rev Nutr. 2004;24:455-79. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Craving indulgence frequency	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	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)
Secondary	Reward-based Eating Drive (RED)	Questionnaire measure of drive to eat for hedonic properties of food	1 month post-intervention
Secondary	Reward-based Eating Drive (RED)	Questionnaire measure of drive to eat for hedonic properties of food	immediate post-intervention (within 7 days of completing the intervention)
Secondary	Palatable Eating Motives Scale, coping subscale	Questionnaire measure of drive to eat for coping	1 month post-intervention
Secondary	Palatable Eating Motives Scale, coping subscale	Questionnaire measure of drive to eat for coping	Immediate post-intervention (within 7 days of completing the intervention)
Secondary	Food Cravings Questionnaire (FCQ-T-R)	Questionnaire measure of food cravings	1 month post-intervention
Secondary	Food Cravings Questionnaire (FCQ-T-R)	Questionnaire measure of food cravings	Immediate post-intervention (within 7 days of completing the intervention)