An interventional study of High Carbohydrate Diet and Reduced Carbohydrate Diet in Disabilities, Obesity and Overweight and Prediabetes, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 30 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.
Behavioral: High Carbohydrate Diet
Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.
Behavioral: Reduced Carbohydrate Diet
Participants randomized to this group will participate in a group-based weight behavioral management program and consume a high carbohydrate (HC) diet. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine HC diet with time-restricted eating (TRE) or HC diet with additional exercise counseling and support.
Participants randomized to this group will participate in a group-based behavioral weight management program and consume a reduced carbohydrate (RC) diet. Because this is a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine RC diet with time-restricted eating (TRE) or RC diet with additional exercise counseling and support.
Change in glucose
Serum glucose will be measured in a fasted state.
Time frame: Baseline & Week 16
Changes in body weight
Measured on validated digital scale
Time frame: Baseline, Week4, and Week 16
Changes in fat mass
As measured by dual-energy X-ray absorptiometry (DEXA)
Time frame: Baseline & Week 16
Change in insulin
Serum insulin will be measured in a fasted state.
Time frame: Baseline & Week 16
Changes in lipids
Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol
Time frame: Baseline & Week 16
Changes in QUICKI index
Predictor of insulin resistance that will be calculated from glucose and insulin measures
Time frame: Baseline & Week 16
Changes in overall strength
As measured by hand grip dynamometry
Time frame: Baseline & Week 16
Changes in aerobic fitness
As measured by graded exercise test using arm crank
Time frame: Baseline & Week 16
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham