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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Behavioral: diet and lifestyle program

• Registration Number: NCT05010083
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-18
• Study Start: 2021-08-23
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
diet and lifestyle program	diet and lifestyle program	-

Primary Outcome Measures

Name	Time	Method
Change in percent bodyweight	4 months	Measured with bodyweight scale

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	4 months	Measured with at-home finger prick analyzed in CLIA certified lab

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States