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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010083
• Other study ID #: HUM00192032
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 23, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• diet and lifestyle program
See description of main arm.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Nutrition Science Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent bodyweight	Measured with bodyweight scale	4 months
Secondary	Change in HbA1c	Measured with at-home finger prick analyzed in CLIA certified lab	4 months