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Clinical Trials/NCT05010083
NCT05010083
Completed
Phase 1

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

University of Michigan1 site in 1 country17 target enrollmentAugust 23, 2021
ConditionsObesity

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Michigan
Enrollment
17
Locations
1
Primary Endpoint
Change in percent bodyweight
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2021
End Date
June 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura Saslow

Assistant Professor

University of Michigan

Eligibility Criteria

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
  • Heart failure
  • Kidney failure
  • History of eating disorders

Outcomes

Primary Outcomes

Change in percent bodyweight

Time Frame: 4 months

Measured with bodyweight scale

Secondary Outcomes

  • Change in HbA1c(4 months)

Study Sites (1)

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