The University of Michigan OWL (Online Wellness and Lifestyle) Study
1 other identifier
interventional
17
1 country
1
Brief Summary
The goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 obesity
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedStudy Start
First participant enrolled
August 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedOctober 24, 2022
October 1, 2022
9 months
August 10, 2021
October 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in percent bodyweight
Measured with bodyweight scale
4 months
Secondary Outcomes (1)
Change in HbA1c
4 months
Study Arms (1)
diet and lifestyle program
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Nutrition Science Initiativecollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Saslow LR, O'Brien A, Raymond K, Bayandorian H, Marriott D, Moskowitz JT, Daubenmier J, Bridges D, Cousineau CM, Griauzde DH. Feasibility and acceptability of an online multicomponent very low-carbohydrate intervention in young adult women with obesity: a pilot study. Pilot Feasibility Stud. 2024 Jul 29;10(1):102. doi: 10.1186/s40814-024-01525-0.
PMID: 39075617DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 10, 2021
First Posted
August 18, 2021
Study Start
August 23, 2021
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
October 24, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share