Feeding BehaviorFIOINCT02930642
Food Insecurity, Obesity, and Impulsive Food Choice
A study testing Mindful Eating and Nutrition DVD in people with Feeding Behavior and Obesity, run by Idaho State University at 1 site in United States.
Trial summary
The objective of this study is to determine the relations among food insecurity status, obesity, and impulsive food choice patterns and to test the extent to which a mindful eating strategy reduces impulsive choice for food. 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
- Feeding Behavior, Obesity, Impulsivity
- What is being tested?
- Mindful Eating and Nutrition DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2017to 3 Mar 2020
- 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
- Must be female
- Must be an adult
- Must score 3-5 (with children) or 3-7 (without children) on the USDA Food Security Module
- Must be English speaking
Who cannot join
- Pregnancy
- Diagnosed with an eating disorder
- HIV
- Hemophilia
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the relations among food insecurity status, obesity, and impulsive food choice patterns and to test the extent to which a mindful eating strategy reduces impulsive choice for food. The central hypothesis is that food-insecure individuals will demonstrate more impulsive food choice patterns and demonstrate a greater likelihood of obesity than individuals who are food secure. Two specific aims are proposed:
Specific aim #1: Determine the relation between food insecurity, obesity, and impulsive food choice patterns in women. The working hypothesis is that food-insecure individuals, especially those that are obese, will exhibit more impulsive food choice patterns than food-secure individuals.
Specific aim #2: Determine the efficacy of an extended mindfulness-based eating strategy on impulsive choice patterns among food insecure women. The working hypothesis is that mindful eating will reduce impulsive food choice patterns relative to baseline and control conditions, and will persist to follow-up. The investigators expect mindful eating to reduce impulsive choice compared to control conditions, despite food security status.
Read the detailed description
The investigators will recruit women from a variety of community locations, including grocery stores, public schools, churches, local food pantries, and from governmental food assistance programs, such as Women, Infants, and Children and the Supplemental Nutrition Assistance Program. Participants will be recruited heavily from settings where low to moderate food security is prevalent, but not severe food security. Food insecurity status will be determined by completion of the 18-item United State Department of Agriculture (USDA) Food Security Module, and will be scored based on standardized scoring techniques. Participants will provide informed consent, be weighed and measured, and complete several questionnaires that measure diet quality, time since last pay check or food benefits as well as other information, such as age, education, ethnicity, employment status, income, marital status, intelligence, nicotine dependence, and alcohol and drug use. Participants will complete baseline delay and probability discounting tasks for food and money as measures of impulsivity.
Then, food insecure women only will be randomly assigned to one of three arms: mindful eating, a nutrition movie, or a control. Participants in the mindful eating group will be given four foods and receive a 50 min mindful eating workshop. Individuals in the nutrition movie condition also will be given the same four foods, but will view a 50 minute nutrition video. The third group (no treatment control) will receive the four foods, but no treatment. A Time 2 measures of discounting will be administered immediately after the treatments.
Then, for the next week after Session 2, participants in the mindful eating group will be asked to practice mindful eating throughout the week. Research assistants will send text message prompts to participants reminding them to record when they practice mindful eating during meals twice per day for one week. Those in the Nutrition movie will receive the same number of prompts during a one week period as the mindful eating group, but they will give give one-word answers to questions about nutrition. Those in the control group will do nothing during the week.
After one week of mindful eating (or controls), all participants will be asked to return to the laboratory and complete a third set of discounting tasks.
- Conditions
- Feeding Behavior, Obesity, Impulsivity
- Being tested
- Mindful Eating, Nutrition DVD
- Keywords
- Mindfulness, Obesity, Food insecurity, Delay discounting
- Medical subject headings
- Feeding Behavior, Obesity, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful EatingBehavioural
Also called Raisin exercise
Mindful eating is a behavioral strategy in which food is eaten slowly, with deliberate and focused attention on the features of food, the process of eating, and physiological responses to eating. Objectivity is key.
Nutrition DVDOther
Participants watch a 50 minute video on nutrition to control for verbal aspects of food.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Eating | Experimental | Participants in this arm will receive a 50 min mindful eating training with four pieces of food. They will practice mindful eating at home with two meals for a one-week duration. Receives: Behavioral: Mindful Eating |
| Nutrition Digital Video Disc (DVD) | Active comparator | Participants will watch a 50 min DVD on nutrition and receive four pieces of food. They will receive prompts twice a week to give one-word answers to questions about food. Receives: Other: Nutrition DVD |
| Control | No intervention | Participants will receive four pieces of food. They will not receive any prompts during the one week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of impulsive choices as assessed by the Food Choice Questionnaire
Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical food-related outcomes
Measured: Two to three weeks
Number of impulsive choices as assessed by the Monetary Choice Questionnaire
Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes
Measured: Two to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start31 May 2017
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idaho State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Rasmussen, PhD, Principal investigator, Idaho State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930642
- Sponsor's protocol ID
- IdahoSU001
- Acronym
- FIOI
- Status last verified
- Mar 2020
- First submitted
- 5 Oct 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lawyer SR, Boomhower SR, Rasmussen EB. Differential associations between obesity and behavioral measures of impulsivity. Appetite. 2015 Dec;95:375-82. doi: 10.1016/j.appet.2015.07.031. Epub 2015 Jul 31.
PubMed 26235925Rasmussen EB, Lawyer SR, Reilly W. Percent body fat is related to delay and probability discounting for food in humans. Behav Processes. 2010 Jan;83(1):23-30. doi: 10.1016/j.beproc.2009.09.001. Epub 2009 Sep 8.
PubMed 19744547Hendrickson KL, Rasmussen EB. Effects of mindful eating training on delay and probability discounting for food and money in obese and healthy-weight individuals. Behav Res Ther. 2013 Jul;51(7):399-409. doi: 10.1016/j.brat.2013.04.002. Epub 2013 Apr 27.
PubMed 23685325Hendrickson KL, Rasmussen EB, Lawyer SR. Measurement and validation of measures for impulsive food choice across obese and healthy-weight individuals. Appetite. 2015 Jul;90:254-63. doi: 10.1016/j.appet.2015.03.015. Epub 2015 Mar 18.
PubMed 25796210Robaina KA, Martin KS. Food insecurity, poor diet quality, and obesity among food pantry participants in Hartford, CT. J Nutr Educ Behav. 2013 Mar;45(2):159-64. doi: 10.1016/j.jneb.2012.07.001. Epub 2012 Dec 5.
PubMed 23219294Townsend MS, Peerson J, Love B, Achterberg C, Murphy SP. Food insecurity is positively related to overweight in women. J Nutr. 2001 Jun;131(6):1738-45. doi: 10.1093/jn/131.6.1738.
PubMed 11385061
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Insecurity, Obesity, and Impulsive Food Choice
- ClinicalTrials.gov ID
- NCT02930642
- Acronym / sponsor ID
- FIOI / IdahoSU001
- Conditions
- Feeding Behavior, Obesity, Impulsivity
- Keywords
- Mindfulness, Obesity, Food insecurity, Delay discounting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Idaho State UniversityUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 12 Oct 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.
The objective of this study is to determine the relations among food insecurity status, obesity, and impulsive food choice patterns and to test the extent to which a mindful eating strategy reduces impulsive choice for food. The central hypothesis is that food-insecure individuals will demonstrate more impulsive food choice patterns and demonstrate a greater likelihood of obesity than individuals who are food secure. Two specific aims are proposed:
Specific aim #1: Determine the relation between food insecurity, obesity, and impulsive food choice patterns in women. The working hypothesis is that food-insecure individuals, especially those that are obese, will exhibit more impulsive food choice patterns than food-secure individuals.
Specific aim #2: Determine the efficacy of an extended mindfulness-based eating strategy on impulsive choice patterns among food insecure women. The working hypothesis is that mindful eating will reduce impulsive food choice patterns relative to baseline and control conditions, and will persist to follow-up. The investigators expect mindful eating to reduce impulsive choice compared to control conditions, despite food security status.
Detailed description
The investigators will recruit women from a variety of community locations, including grocery stores, public schools, churches, local food pantries, and from governmental food assistance programs, such as Women, Infants, and Children and the Supplemental Nutrition Assistance Program. Participants will be recruited heavily from settings where low to moderate food security is prevalent, but not severe food security. Food insecurity status will be determined by completion of the 18-item United State Department of Agriculture (USDA) Food Security Module, and will be scored based on standardized scoring techniques. Participants will provide informed consent, be weighed and measured, and complete several questionnaires that measure diet quality, time since last pay check or food benefits as well as other information, such as age, education, ethnicity, employment status, income, marital status, intelligence, nicotine dependence, and alcohol and drug use. Participants will complete baseline delay and probability discounting tasks for food and money as measures of impulsivity.
Then, food insecure women only will be randomly assigned to one of three arms: mindful eating, a nutrition movie, or a control. Participants in the mindful eating group will be given four foods and receive a 50 min mindful eating workshop. Individuals in the nutrition movie condition also will be given the same four foods, but will view a 50 minute nutrition video. The third group (no treatment control) will receive the four foods, but no treatment. A Time 2 measures of discounting will be administered immediately after the treatments.
Then, for the next week after Session 2, participants in the mindful eating group will be asked to practice mindful eating throughout the week. Research assistants will send text message prompts to participants reminding them to record when they practice mindful eating during meals twice per day for one week. Those in the Nutrition movie will receive the same number of prompts during a one week period as the mindful eating group, but they will give give one-word answers to questions about nutrition. Those in the control group will do nothing during the week.
After one week of mindful eating (or controls), all participants will be asked to return to the laboratory and complete a third set of discounting tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindful Eating | Experimental | Behavioral: Mindful EatingParticipants in this arm will receive a 50 min mindful eating training with four pieces of food. They will practice mindful eating at home with two meals for a one-week duration. |
| Nutrition Digital Video Disc (DVD) | Active comparator | Other: Nutrition DVDParticipants will watch a 50 min DVD on nutrition and receive four pieces of food. They will receive prompts twice a week to give one-word answers to questions about food. |
| Control | No intervention | –Participants will receive four pieces of food. They will not receive any prompts during the one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be female
- Must be an adult
- Must score 3-5 (with children) or 3-7 (without children) on the USDA Food Security Module
- Must be English speaking
Key exclusion criteria (4 listed)
- Pregnancy
- Diagnosed with an eating disorder
- HIV
- Hemophilia
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 |
|---|---|---|
| Mindful EatingAlso: Raisin exerciseMindful eating is a behavioral strategy in which food is eaten slowly, with deliberate and focused attention on the features of food, the process of eating, and physiological responses to eating. Objectivity is key. | Behavioural | Mindful Eating |
| Nutrition DVDParticipants watch a 50 minute video on nutrition to control for verbal aspects of food. | Other | Nutrition Digital Video Disc (DVD) |
Primary outcome
Number of impulsive choices as assessed by the Food Choice Questionnaire
Time frame: Two to three weeks
Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical food-related outcomes
Number of impulsive choices as assessed by the Monetary Choice Questionnaire
Time frame: Two to three weeks
Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes
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 4 Mar 2020.
- Background: PubMed 26235925Lawyer SR, Boomhower SR, Rasmussen EB. Differential associations between obesity and behavioral measures of impulsivity. Appetite. 2015 Dec;95:375-82. doi: 10.1016/j.appet.2015.07.031. Epub 2015 Jul 31.
- Background: PubMed 19744547Rasmussen EB, Lawyer SR, Reilly W. Percent body fat is related to delay and probability discounting for food in humans. Behav Processes. 2010 Jan;83(1):23-30. doi: 10.1016/j.beproc.2009.09.001. Epub 2009 Sep 8.
- Background: PubMed 23685325Hendrickson KL, Rasmussen EB. Effects of mindful eating training on delay and probability discounting for food and money in obese and healthy-weight individuals. Behav Res Ther. 2013 Jul;51(7):399-409. doi: 10.1016/j.brat.2013.04.002. Epub 2013 Apr 27.
- Background: PubMed 25796210Hendrickson KL, Rasmussen EB, Lawyer SR. Measurement and validation of measures for impulsive food choice across obese and healthy-weight individuals. Appetite. 2015 Jul;90:254-63. doi: 10.1016/j.appet.2015.03.015. Epub 2015 Mar 18.
- Background: PubMed 23219294Robaina KA, Martin KS. Food insecurity, poor diet quality, and obesity among food pantry participants in Hartford, CT. J Nutr Educ Behav. 2013 Mar;45(2):159-64. doi: 10.1016/j.jneb.2012.07.001. Epub 2012 Dec 5.
- Background: PubMed 11385061Townsend MS, Peerson J, Love B, Achterberg C, Murphy SP. Food insecurity is positively related to overweight in women. J Nutr. 2001 Jun;131(6):1738-45. doi: 10.1093/jn/131.6.1738.
- Individual participant dataSharing planned: Yes
Related trials for Feeding Behavior
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
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.
Erin Rasmussen, PhD principal investigator
Idaho State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Eating and Nutrition DVD in people with Feeding Behavior and Obesity, run by Idaho State University 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 4 inclusion and 4 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 4 Mar 2020. 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?
Number of impulsive choices as assessed by the Food Choice Questionnaire (time frame: Two to three weeks). The study lists 2 primary outcomes in all. 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 NCT02930642, which also lists 6 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 4 Mar 2020.