Food CravingsNCT02694731
A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings
A study testing Mobile application intervention (Device: Smartphone) in people with Food Cravings, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food Cravings
- What is being tested?
- Mobile application intervention (Device: Smartphone)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Food Cravings
- Being tested
- Mobile application intervention (Device: Smartphone)
- Keywords
- Craving, Mobile Apps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application intervention (Device: Smartphone)Behavioural
Consists of the app described in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application intervention | Experimental | Participants receive a mobile app with a 5-week mindful eating program and ongoing tools for coping with cravings Receives: Behavioral: Mobile application intervention (Device: Smartphone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month post-intervention
Secondary outcomes (7)
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
Measured: 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)
Questionnaire measure of drive to eat for hedonic properties of food
Measured: 1 month post-intervention
Reward-based Eating Drive (RED)
Questionnaire measure of drive to eat for hedonic properties of food
Measured: immediate post-intervention (within 7 days of completing the intervention)
Palatable Eating Motives Scale, coping subscale
Questionnaire measure of drive to eat for coping
Measured: 1 month post-intervention
Palatable Eating Motives Scale, coping subscale
Questionnaire measure of drive to eat for coping
Measured: Immediate post-intervention (within 7 days of completing the intervention)
Food Cravings Questionnaire (FCQ-T-R)
Questionnaire measure of food cravings
Measured: 1 month post-intervention
Food Cravings Questionnaire (FCQ-T-R)
Questionnaire measure of food cravings
Measured: Immediate post-intervention (within 7 days of completing the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion29 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Food CravingsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley E Mason, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694731
- Sponsor's protocol ID
- 15-17250
- Status last verified
- May 2017
- First submitted
- 24 Feb 2016
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigators will deposit anonymized individual-level data in a depository such as the Open Science Framework.
Publications
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.
PubMed 15189128Gendall 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.
PubMed 9134095Epel 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.
PubMed 24979216Sagui-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.
PubMed 34584574Mason 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.
PubMed 28918456
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings
- ClinicalTrials.gov ID
- NCT02694731
- Acronym / sponsor ID
- 15-17250
- Conditions
- Food Cravings
- Keywords
- Craving, Mobile Apps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 29 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile application intervention | Experimental | Behavioral: Mobile application intervention (Device: Smartphone)Participants receive a mobile app with a 5-week mindful eating program and ongoing tools for coping with cravings |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application intervention (Device: Smartphone)Consists of the app described in the arm description. | Behavioural | Mobile application intervention |
Primary outcome
Craving indulgence frequency
Time frame: 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
7 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Background: PubMed 15189128Wansink 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.
- Background: PubMed 9134095Gendall 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.
- Background: PubMed 24979216Epel 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.
- Derived from this study: PubMed 34584574Sagui-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.
- Derived from this study: PubMed 28918456Mason 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.
- Individual participant dataSharing planned: Yes. The investigators will deposit anonymized individual-level data in a depository such as the Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley E Mason, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application intervention (Device: Smartphone) in people with Food Cravings, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving indulgence frequency (time frame: 1 month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694731, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.