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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2022-06-01

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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diet and lifestyle program

Group Type EXPERIMENTAL

diet and lifestyle program

Intervention Type BEHAVIORAL

See description of main arm.

Interventions

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diet and lifestyle program

See description of main arm.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No