Weight LossNCT06269094
A Study to Understand How Continuous Glucose Monitors Impact Eating Behavior
A study testing CGM in people with Weight Loss, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- CGM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 3 May 2024
- 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
- Male or female, 18-60 y of age.
- Individual is attempting to lose ≥15 lbs.
- Individual is able to articulate a weight loss plan.
- Individual is a primary or co-primary grocery shopper (i.e., does all or most of the grocery shopping for the household or shares the responsibility with someone else).
- Individual shops for household food and beverages at mainstream grocery stores (e.g., Walmart, Target, Publix, Aldi, Costco, Sam's Club, etc.).
- Individual consumes packaged food within ≥2 General Mills categories (cereal, bars, yogurt, and soups).
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- Individual has attained a high school diploma or a General Educational Development (GED) equivalent.
- Individual has a household income ≥$30,000 per year before taxes.
- Individual has not participated in another research study within 1 month of the screening visit.
- Individual has access to reliable technology and high-speed internet to attend virtual focus groups and review CGM data in real-time.
- Individual is willing and able to undergo the scheduled study procedures, including use of a CGM for 6 weeks, complete food logs, answer weekly survey questions, and participate in online group discussions.
- Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Individual or someone in the household works as a registered dietitian or fitness professional.
- Individual or someone in the household works for a medical device company for diabetes management.
- Individual or someone in the household works in the medical field as a nurse, medical doctor, physician assistant, or a close equivalent.
- Individual or someone in the household currently uses a CGM.
- Individual has a clinically significant endocrine (e.g., diabetes) or gastrointestinal condition that could interfere with the interpretation of the study results.
- Individual has a history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
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- Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
- Individual has a history of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
- Individual has a history of bariatric surgery.
- Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Individual has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Consumer Pilot Study to Understand How Continuous Glucose Monitors Impact Eating Behavior in Individuals Attempting to Lose Weight
The purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach.
- Conditions
- Weight Loss
- Being tested
- CGM
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMOther
CGM use for 6 weeks during virtual focus groups
| Study group | Role | What they receive |
|---|---|---|
| CGM | Experimental | Not described Receives: Other: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative insights on consumer behavior
Discussions during the virtual focus groups will provide qualitative insights on if/how consumer behavior (related to food choice, eating behavior, and purchasing) changes when using a CGM.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start14 Feb 2024
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, PhD, Study director, Midwest Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269094
- Sponsor's protocol ID
- MB-2312
- Status last verified
- May 2024
- First submitted
- 13 Feb 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Consumer Pilot Study to Understand How Continuous Glucose Monitors Impact Eating Behavior in Individuals Attempting to Lose Weight
- ClinicalTrials.gov ID
- NCT06269094
- Acronym / sponsor ID
- MB-2312
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 21 Feb 2024 (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 purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM | Experimental | Other: CGM |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female, 18-60 y of age.
- Individual is attempting to lose ≥15 lbs.
- Individual is able to articulate a weight loss plan.
- Individual is a primary or co-primary grocery shopper (i.e., does all or most of the grocery shopping for the household or shares the responsibility with someone else).
- Individual shops for household food and beverages at mainstream grocery stores (e.g., Walmart, Target, Publix, Aldi, Costco, Sam's Club, etc.).
Key exclusion criteria (12 listed)
- Individual or someone in the household works as a registered dietitian or fitness professional.
- Individual or someone in the household works for a medical device company for diabetes management.
- Individual or someone in the household works in the medical field as a nurse, medical doctor, physician assistant, or a close equivalent.
- Individual or someone in the household currently uses a CGM.
- Individual has a clinically significant endocrine (e.g., diabetes) or gastrointestinal condition that could interfere with the interpretation of the study results.
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 |
|---|---|---|
| CGMCGM use for 6 weeks during virtual focus groups | Other | CGM |
Primary outcome
Qualitative insights on consumer behavior
Time frame: 6 weeks
Discussions during the virtual focus groups will provide qualitative insights on if/how consumer behavior (related to food choice, eating behavior, and purchasing) changes when using a CGM.
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 17 May 2024.
- 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.
Kevin Maki, PhD study director
Midwest Biomedical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM in people with Weight Loss, run by Midwest Center for Metabolic and Cardiovascular Research 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 12 inclusion and 12 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 17 May 2024. 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?
Qualitative insights on consumer behavior (time frame: 6 weeks). 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 17 May 2024.