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

• Sponsor: University of Michigan (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05010083
• Collaborator: Nutrition Science Initiative (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 13.3
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: diet and lifestyle program	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The University of Michigan OWL (Online Wellness and Lifestyle) Study
• Actual Study Start Date: Aug 23, 2021
• Actual Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: diet and lifestyle program	Behavioral: diet and lifestyle program; See description of main arm.

Outcome Measures

Primary Outcome Measures

1. Change in percent bodyweight [4 months]

   Measured with bodyweight scale

Secondary Outcome Measures

1. Change in HbA1c [4 months]

   Measured with at-home finger prick analyzed in CLIA certified lab

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• Nutrition Science Initiative

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Saslow, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT05010083
• Other Study ID Numbers: HUM00192032
• First Posted: Aug 18, 2021
• Last Update Posted: Jul 6, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Laura Saslow, Assistant Professor, University of Michigan: nutrition; Diet, Ketogenic; Diet, Carbohydrate-Restricted

Study Results

No Results Posted as of Jul 6, 2022