20
Participants
Start Date
June 22, 2022
Primary Completion Date
December 16, 2022
Study Completion Date
December 16, 2022
Continuous Energy Restriction (CER)
Energy intake will be prescribed at approximately 1,200-1,500 kcal/day with high protein. The diet will consist of low-calorie shakes provided by the study, as well as commercially available portion-controlled entrées, fruits/vegetables, and low energy-density foods available in grocery stores.
Alternate Day Modified Fasting (ADMF)
Enhanced Care participants will have an alternate between three days of very-low energy intake (VLED; approximately 600-800 kcal/d) and four days of healthy eating (HE) each week. On HE days, participants will consume foods ad libitum for satiety.
Group Health Education Sessions
Using video conferencing, all participants will attend weekly approximately 45-60 minutes group health education sessions led by a registered dietitian. The session will deliver a comprehensive nutritional and lifestyle change program to promote lifestyle changes and improve compliance.
Late Evening Snack
The participants will have a late evening snack with a protein supplement.
Physical activity
All participants will be prescribed moderate-intensity aerobic activities that do not require access to specialized exercise facilities.
Self-monitoring
Weekly data related to adherence, food intake, physical activity, weight measurement, and nonserious adverse events will be self-reported via a REDCap survey. Participants will also be provided with a wireless activity tracker to measure total physical activity and intensity of activity objectively. These data will be used to counsel participants in addition to providing valuable feasibility data.
Remotely Supervised Exercise Sessions
Sessions of 45 minutes duration will be delivered via video conferencing 2-3 times per week.
University of Kansas Medical Center, Kansas City
University of Kansas Medical Center
OTHER