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| ID | Type | Description | Link |
|---|---|---|---|
| CEDHARS | Other Grant/Funding Number | Center for Engagement in Disability Health and Rehabilitation Sciences (CEDHARS); University of Alabama at Birmingham |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Carbohydrate Diet | Experimental | Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan. |
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| Reduced Carbohydrate Diet | Experimental | Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Carbohydrate Diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose | Serum glucose will be measured in a fasted state. | Baseline & Week 16 |
| Changes in body weight | Measured on validated digital scale | Baseline, Week4, and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fat mass | As measured by dual-energy X-ray absorptiometry (DEXA) | Baseline & Week 16 |
| Change in insulin | Serum insulin will be measured in a fasted state. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Ferguson, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellness Health and Research Facility (WHARF) | Birmingham | Alabama | 35209 | United States |
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| Reduced Carbohydrate Diet | Behavioral | 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. |
|
| Baseline & Week 16 |
| Changes in lipids | Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol | Baseline & Week 16 |
| Changes in QUICKI index | Predictor of insulin resistance that will be calculated from glucose and insulin measures | Baseline & Week 16 |
| Changes in overall strength | As measured by hand grip dynamometry | Baseline & Week 16 |
| Changes in aerobic fitness | As measured by graded exercise test using arm crank | Baseline & Week 16 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D011236 | Prediabetic State |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D000076107 | Diet, High-Protein Low-Carbohydrate |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D000073600 | Diet, High-Protein |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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