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Completed

NCT Number: NCT05010083

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

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diet and lifestyle program

Behavioral

See description of main arm.

Primary outcomes

  1. Change in percent bodyweight

    Time frame: 4 months

    Measured with bodyweight scale

Secondary outcomes

  1. Change in HbA1c

    Time frame: 4 months

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Nutrition Science Initiative

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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