Overweight and ObesityNCT03976427
Translating Neuroscience to Population Health
A study testing Guided Imagery in people with Overweight and Obesity, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The current study will examine the relationship between brain responses and a guided imagery exercise in overweight and obese individuals. Results of this work are highly relevant to public health because they employ neuroimaging methods to understand food decision-making. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 11 Jul 2019
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index 25 to 55 kg/m2
- right-handed
- not currently dieting or attempting to lose weight.
Who cannot join
- serious medical illness unsuitable for the magnetic resonance imaging scanner based on best clinical judgment
- any neurologic or current psychiatric diagnosis
- currently taking anti-seizure medication
- history of concussion
- left-handedness
- risk for hazard due to magnetic fields such as metal in the body surgically or accidentally
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Changing How the Brain Responds When Making Decisions: Translating Neuroscience to Population Health
The current study will examine the relationship between brain responses and a guided imagery exercise in overweight and obese individuals. Results of this work are highly relevant to public health because they employ neuroimaging methods to understand food decision-making. Findings from this study will inform health decision making and holds great potential for future translation across multiple health behaviors and scalable interventions to impact population health
Read the detailed description
Negative health behaviors (e.g. overeating, smoking) are associated with increased negative health outcomes. Engaging in healthy behaviors is not always rewarding (e.g. carrot vs. cake). Neural models of healthy behaviors focus on the balance between reward and regulation brain regions. The current pilot application examines the engagement of these regions during the evaluation of food and nonfood cues before and after a guided imagery exercise targeting positive associations with food and regulation.
The long-term goal is to understand the interaction between positive associations with healthy foods and thinking about future rewards may influence healthy decision-making. The objective of the current study is to empirically test the combined effects of positive affect and positive episodic future thinking on brain activation.
- Conditions
- Overweight and Obesity
- Being tested
- Guided Imagery
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves.
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery | Experimental | Participants will listen to a guided imagery recording Receives: Behavioral: Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Activation in Self-Regulation Brain Regions
Functional Magnetic Resonance Imaging will measure brain activation changes in self-regulation brain regions including the dorsolateral prefrontal cortex, dorsomedial prefrontal cortex and anterior cingulate cortex when participants view healthy compared to unhealthy food images before and after the guided imagery exercise
Measured: 1 hour
Brain Activation in Reward Brain Regions
Functional Magnetic Resonance Imaging will measure brain activation changes in reward brain regions including the ventromedial prefrontal cortex and striatum when participants view healthy compared to unhealthy food images before and after the guided imagery exercise
Measured: 1 hour
Secondary outcomes (2)
Food Choice
Observational preference for healthy compared to unhealthy food choices measured by the number of healthy and unhealthy foods selected following the guided imagery exercise
Measured: 1 hour
Food Demand
Behavioral changes in demand for healthy compared to unhealthy foods will be measured by asking participants to indicate how healthy and unhealthy food items they would eat in a day if the items were freely available
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start24 Apr 2019
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be assigned to a guided imagery exercise
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976427
- Sponsor's protocol ID
- STUDY00142526
- Status last verified
- Aug 2019
- First submitted
- 29 May 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for primary outcomes will be made available
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing How the Brain Responds When Making Decisions: Translating Neuroscience to Population Health
- ClinicalTrials.gov ID
- NCT03976427
- Acronym / sponsor ID
- STUDY00142526
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- 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 current study will examine the relationship between brain responses and a guided imagery exercise in overweight and obese individuals. Results of this work are highly relevant to public health because they employ neuroimaging methods to understand food decision-making. Findings from this study will inform health decision making and holds great potential for future translation across multiple health behaviors and scalable interventions to impact population health
Detailed description
Negative health behaviors (e.g. overeating, smoking) are associated with increased negative health outcomes. Engaging in healthy behaviors is not always rewarding (e.g. carrot vs. cake). Neural models of healthy behaviors focus on the balance between reward and regulation brain regions. The current pilot application examines the engagement of these regions during the evaluation of food and nonfood cues before and after a guided imagery exercise targeting positive associations with food and regulation.
The long-term goal is to understand the interaction between positive associations with healthy foods and thinking about future rewards may influence healthy decision-making. The objective of the current study is to empirically test the combined effects of positive affect and positive episodic future thinking on brain activation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be assigned to a guided imagery exercise
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Behavioral: Guided ImageryParticipants will listen to a guided imagery recording |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- body mass index 25 to 55 kg/m2
- right-handed
- not currently dieting or attempting to lose weight.
Key exclusion criteria (7 listed)
- serious medical illness unsuitable for the magnetic resonance imaging scanner based on best clinical judgment
- any neurologic or current psychiatric diagnosis
- currently taking anti-seizure medication
- history of concussion
- left-handedness
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 |
|---|---|---|
| Guided ImageryThe guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves. | Behavioural | Guided Imagery |
Primary outcome
Brain Activation in Self-Regulation Brain Regions
Time frame: 1 hour
Functional Magnetic Resonance Imaging will measure brain activation changes in self-regulation brain regions including the dorsolateral prefrontal cortex, dorsomedial prefrontal cortex and anterior cingulate cortex when participants view healthy compared to unhealthy food images before and after the guided imagery exercise
Brain Activation in Reward Brain Regions
Time frame: 1 hour
Functional Magnetic Resonance Imaging will measure brain activation changes in reward brain regions including the ventromedial prefrontal cortex and striatum when participants view healthy compared to unhealthy food images before and after the guided imagery exercise
2 secondary outcomes
Food Choice
Time frame: 1 hour
Food Demand
Time frame: 1 hour
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 5 Aug 2019.
- Individual participant dataSharing planned: Yes. De-identified data for primary outcomes will be made available
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Overweight and Obesity, run by University of Kansas Medical Center 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 3 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 5 Aug 2019. 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?
Brain Activation in Self-Regulation Brain Regions (time frame: 1 hour). 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?
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 5 Aug 2019.