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The University of Michigan OWL (Online Wellness and Lifestyle) Study

The University of Michigan OWL (Online Wellness and Lifestyle) Study

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05010083
Enrollment
17
Registered
2021-08-18
Start date
2021-08-23
Completion date
2022-06-01
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

nutrition, Diet, Ketogenic, Diet, Carbohydrate-Restricted

Brief summary

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.

Interventions

See description of main arm.

Sponsors

Nutrition Science Initiative
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Change in percent bodyweight4 monthsMeasured with bodyweight scale

Secondary

MeasureTime frameDescription
Change in HbA1c4 monthsMeasured with at-home finger prick analyzed in CLIA certified lab

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026