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

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University of Michigan

Status and phase

Completed
Phase 2
Phase 1

Conditions

Obesity

Treatments

Behavioral: diet and lifestyle program

Study type

Interventional

Funder types

Other

Identifiers

NCT05010083
HUM00192032

Details and patient eligibility

About

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

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

diet and lifestyle program
Experimental group
Treatment:
Behavioral: diet and lifestyle program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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