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

Study Overview
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Brief Summary
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The goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: diet and lifestyle program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diet and lifestyle program<br> | Behavioral: diet and lifestyle program<br>* See description of main arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent bodyweight | Measured with bodyweight scale | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Measured with at-home finger prick analyzed in CLIA certified lab | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, Diet, Ketogenic, Diet, Carbohydrate-Restricted