ObesityPhase 1/2NCT05010083
The University of Michigan OWL (Online Wellness and Lifestyle) Study
A Phase 1/2 study testing diet and lifestyle program in people with Obesity, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Obesity
- What is being tested?
- diet and lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 1 Jun 2022
- Phase
- Phase 1/2
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-25
- Obese (BMI ≥ 30)
- Sufficient control over diet
- Access to internet and texting
- Living in the United States
- Willing and able to follow intervention and complete measurements
Who cannot join
- Non-English speaking
- Pregnant, breastfeeding, or planning to be in the next 6 months
- Vegan or vegetarian
- Currently enrolled in weight loss program
- Taking medications known to cause weight loss or gain
- Taking glucose-lowering medications other than metformin
Show all 14Show fewer
- Type 1 diabetes
- Cancer
- Heart failure
- Kidney failure
- History of eating disorders
- Untreated psychiatric disorder
- History of or planned weight loss surgery
- Consumption of greater than 30 alcoholic beverages per week
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults.
Read the detailed description
Obesity increases the risk of a variety of illnesses such as heart disease, type 2 diabetes, cancer, sleep apnea, asthma, and depression. While advice from the Centers for Disease Control, American Heart Association, and the National Institutes of Health recommend a low-fat diet with a focus on whole grains and lean meats, research shows that a very low-carbohydrate diet may be more effective at reducing body mass index (BMI). Given the disconnect between recommendations and research, higher quality, long term, large trials are needed. In preparation for that research, the investigators plan to pilot test a very low-carbohydrate diet program, the OWL study (Online Wellness and Lifestyle Study), for 30 young adults followed over 4 months.
- Conditions
- Obesity
- Being tested
- diet and lifestyle program
- Keywords
- nutrition, Diet, Ketogenic, Diet, Carbohydrate-Restricted
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and lifestyle programBehavioural
See description of main arm.
| Study group | Role | What they receive |
|---|---|---|
| diet and lifestyle program | Experimental | Not described Receives: Behavioral: diet and lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent bodyweight
Measured with bodyweight scale
Measured: 4 months
Secondary outcomes (1)
Change in HbA1c
Measured with at-home finger prick analyzed in CLIA certified lab
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start23 Aug 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
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 ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrition Science Initiative
- Responsible party
- Principal investigator, Laura Saslow, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010083
- Sponsor's protocol ID
- HUM00192032
- Status last verified
- Oct 2022
- First submitted
- 10 Aug 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saslow LR, O'Brien A, Raymond K, Bayandorian H, Marriott D, Moskowitz JT, Daubenmier J, Bridges D, Cousineau CM, Griauzde DH. Feasibility and acceptability of an online multicomponent very low-carbohydrate intervention in young adult women with obesity: a pilot study. Pilot Feasibility Stud. 2024 Jul 29;10(1):102. doi: 10.1186/s40814-024-01525-0.
PubMed 39075617
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University of Michigan OWL (Online Wellness and Lifestyle) Study
- ClinicalTrials.gov ID
- NCT05010083
- Acronym / sponsor ID
- HUM00192032
- Conditions
- Obesity
- Keywords
- nutrition, Diet, Ketogenic, Diet, Carbohydrate-Restricted
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Nutrition Science Initiative
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 18 Aug 2021 (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 goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults.
Detailed description
Obesity increases the risk of a variety of illnesses such as heart disease, type 2 diabetes, cancer, sleep apnea, asthma, and depression. While advice from the Centers for Disease Control, American Heart Association, and the National Institutes of Health recommend a low-fat diet with a focus on whole grains and lean meats, research shows that a very low-carbohydrate diet may be more effective at reducing body mass index (BMI). Given the disconnect between recommendations and research, higher quality, long term, large trials are needed. In preparation for that research, the investigators plan to pilot test a very low-carbohydrate diet program, the OWL study (Online Wellness and Lifestyle Study), for 30 young adults followed over 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diet and lifestyle program | Experimental | Behavioral: diet and lifestyle program |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-25
- Obese (BMI ≥ 30)
- Sufficient control over diet
- Access to internet and texting
- Living in the United States
Key exclusion criteria (14 listed)
- Non-English speaking
- Pregnant, breastfeeding, or planning to be in the next 6 months
- Vegan or vegetarian
- Currently enrolled in weight loss program
- Taking medications known to cause weight loss or gain
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 |
|---|---|---|
| diet and lifestyle programSee description of main arm. | Behavioural | diet and lifestyle program |
Primary outcome
Change in percent bodyweight
Time frame: 4 months
Measured with bodyweight scale
1 secondary outcome
Change in HbA1c
Time frame: 4 months
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 24 Oct 2022.
- Derived from this study: PubMed 39075617Saslow LR, O'Brien A, Raymond K, Bayandorian H, Marriott D, Moskowitz JT, Daubenmier J, Bridges D, Cousineau CM, Griauzde DH. Feasibility and acceptability of an online multicomponent very low-carbohydrate intervention in young adult women with obesity: a pilot study. Pilot Feasibility Stud. 2024 Jul 29;10(1):102. doi: 10.1186/s40814-024-01525-0.
- 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.
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 Phase 1/2 study testing diet and lifestyle program in people with Obesity, run by University of Michigan 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 6 inclusion and 14 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 24 Oct 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in percent bodyweight (time frame: 4 months). 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 NCT05010083, 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 24 Oct 2022.