Eating BehaviorGCENCT03850990
Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss
A study of Eating Behavior and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The study will assess the effect of attending to stomach-cues of hunger and fullness on body weight and any additional benefit provided by open-label placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Obesity, Body Weight
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to 30 May 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Desire to lose weight
- 18-60 years of age
- Student of employee at the University of Alabama at Birmingham
Who cannot join
- Current enrollment in commercial weight loss program
- Uncontrolled diabetes
- Uncontrolled hypertension
- Current bipolar disorder
- Current or history of eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
The study will assess the effect of attending to stomach-cues of hunger and fullness on body weight and any additional benefit provided by open-label placebo.
Read the detailed description
Students and employees from the University of Alabama at Birmingham will consent to four lab visits. On the first visit, they will get measured for a BMI, complete surveys about eating and cognitive styles. They will also get their heart rate and blood pressure taken, and provide a saliva sample for saliva quantification with dental cotton rolls in the mouth before and after a food-craving task (rating computer photos of various foods for liking and desire). They will then see a video explaining the difference between mouth and stomach hunger and instructing them to use a hunger meter to know when to start eating and when to stop eating. They will have a chance to ask questions and will receive a hard copy of the video. They will also receive a satiety tips sheet and will give permission to receive and start receiving daily motivational text messages for the next 2 weeks.
At this time all participants will also watch a short video about placebos and the effect that open-label placebos (non-deceptive placebos; the person knows they are receiving a placebo) have had on previous studies unrelated to obesity or weight loss. If randomized to the placebo group they will take 2 capsules of micro-crystalline cellulose, a non-bioactive ingredient, every day for the duration of the study. Those in the no placebo group will not receive the pills.
The second visit will take place 2 weeks after the first visit. They will be measured for another BMI, complete a meal patterns questionnaire, and have a progress interview about their experience with the new eating instructions. They will receive answers and suggestions corresponding to their interview responses on any challenges faced. Those in the placebo group will have a chance to have any questions or concerns addressed. All participants will then be scheduled for their next visit and will receive the text messages twice a week for the next 3 weeks.
The third visit will take place 3 weeks after the second visit. They will be measured again for a BMI, complete another meal patterns questionnaire, have another progress interview, and get scheduled for their last visit. No text messages will go out between this and the fourth visit.
The fourth visit will take place 3 weeks after the third visit. They will be measured for a BMI and complete another meal patterns questionnaire. They will also get another heart rate, blood pressure, and saliva quantification reading before and after the food-craving task as in the first visit. They will have a final progress interview, followed by a debriefing meeting to let them know more about the study and answer any questions related to any part of the study. They will then be asked if they want to know more about their survey and questionnaire scores. Those in the no placebo group who wish to take placebos will grant permission to be contacted for any future studies that include a placebo group.
- Conditions
- Eating Behavior, Obesity, Body Weight, Hunger
- Being tested
- Placebo pill and no placebo pill
- Medical subject headings
- Feeding Behavior, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo pill and no placebo pillBehavioural
The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Experimental | In the first visit, this group will learn about placebo pills from a video and will be placebo pills to take twice a day for 8 weeks. They will be asked to take the pills in conjunction with following the weight-loss protocol. Receives: Behavioral: Placebo pill and no placebo pill |
| No placebo group | Experimental | In the first visit, this group will learn about placebo pills from a video but will not be given placebo pills. They will follow the weight-loss protocol without placebo pills. Receives: Behavioral: Placebo pill and no placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Change in body mass index over 8 weeks on the protocol.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start25 Sep 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single group will be assessed for change in body weight across time.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Boggiano, University of Alabama at Birmingham
- Investigators
- Mary M Boggiano, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850990
- Sponsor's protocol ID
- IRB-300000000
- Acronym
- GCE
- Status last verified
- Jun 2021
- First submitted
- 20 Feb 2019
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
White TR, Wood AS, Ebeling M, Braswell AC, Lausen MA, Isaac S, Gampher JE, Boggiano MM. Change in craving and frequency of consuming palatable foods for non-homeostatic motives after a gut-cued eating intervention. Eat Behav. 2022 Aug;46:101656. doi: 10.1016/j.eatbeh.2022.101656. Epub 2022 Jul 28.
PubMed 35944376
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss
- ClinicalTrials.gov ID
- NCT03850990
- Acronym / sponsor ID
- GCE / IRB-300000000
- Conditions
- Eating Behavior, Obesity, Body Weight, Hunger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 22 Feb 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 study will assess the effect of attending to stomach-cues of hunger and fullness on body weight and any additional benefit provided by open-label placebo.
Detailed description
Students and employees from the University of Alabama at Birmingham will consent to four lab visits. On the first visit, they will get measured for a BMI, complete surveys about eating and cognitive styles. They will also get their heart rate and blood pressure taken, and provide a saliva sample for saliva quantification with dental cotton rolls in the mouth before and after a food-craving task (rating computer photos of various foods for liking and desire). They will then see a video explaining the difference between mouth and stomach hunger and instructing them to use a hunger meter to know when to start eating and when to stop eating. They will have a chance to ask questions and will receive a hard copy of the video. They will also receive a satiety tips sheet and will give permission to receive and start receiving daily motivational text messages for the next 2 weeks.
At this time all participants will also watch a short video about placebos and the effect that open-label placebos (non-deceptive placebos; the person knows they are receiving a placebo) have had on previous studies unrelated to obesity or weight loss. If randomized to the placebo group they will take 2 capsules of micro-crystalline cellulose, a non-bioactive ingredient, every day for the duration of the study. Those in the no placebo group will not receive the pills.
The second visit will take place 2 weeks after the first visit. They will be measured for another BMI, complete a meal patterns questionnaire, and have a progress interview about their experience with the new eating instructions. They will receive answers and suggestions corresponding to their interview responses on any challenges faced. Those in the placebo group will have a chance to have any questions or concerns addressed. All participants will then be scheduled for their next visit and will receive the text messages twice a week for the next 3 weeks.
The third visit will take place 3 weeks after the second visit. They will be measured again for a BMI, complete another meal patterns questionnaire, have another progress interview, and get scheduled for their last visit. No text messages will go out between this and the fourth visit.
The fourth visit will take place 3 weeks after the third visit. They will be measured for a BMI and complete another meal patterns questionnaire. They will also get another heart rate, blood pressure, and saliva quantification reading before and after the food-craving task as in the first visit. They will have a final progress interview, followed by a debriefing meeting to let them know more about the study and answer any questions related to any part of the study. They will then be asked if they want to know more about their survey and questionnaire scores. Those in the no placebo group who wish to take placebos will grant permission to be contacted for any future studies that include a placebo group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single group will be assessed for change in body weight across time.
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Experimental | Behavioral: Placebo pill and no placebo pillIn the first visit, this group will learn about placebo pills from a video and will be placebo pills to take twice a day for 8 weeks. They will be asked to take the pills in conjunction with following the weight-loss protocol. |
| No placebo group | Experimental | Behavioral: Placebo pill and no placebo pillIn the first visit, this group will learn about placebo pills from a video but will not be given placebo pills. They will follow the weight-loss protocol without placebo pills. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Desire to lose weight
- 18-60 years of age
- Student of employee at the University of Alabama at Birmingham
Key exclusion criteria (5 listed)
- Current enrollment in commercial weight loss program
- Uncontrolled diabetes
- Uncontrolled hypertension
- Current bipolar disorder
- Current or history of eating disorder
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 |
|---|---|---|
| Placebo pill and no placebo pillThe placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients. | Behavioural | No placebo group, Placebo group |
Primary outcome
BMI
Time frame: 8 weeks
Change in body mass index over 8 weeks on the protocol.
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 Jun 2021.
- Derived from this study: PubMed 35944376White TR, Wood AS, Ebeling M, Braswell AC, Lausen MA, Isaac S, Gampher JE, Boggiano MM. Change in craving and frequency of consuming palatable foods for non-homeostatic motives after a gut-cued eating intervention. Eat Behav. 2022 Aug;46:101656. doi: 10.1016/j.eatbeh.2022.101656. Epub 2022 Jul 28.
- Individual participant dataSharing planned: No
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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.
Mary M Boggiano, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Eating Behavior and Obesity, run by University of Alabama at Birmingham 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 5 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 Jun 2021. 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?
BMI (time frame: 8 weeks). 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 NCT03850990, which also lists 1 linked publication.
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 Jun 2021.