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| ID | Type | Description | Link |
|---|---|---|---|
| General Mills | Other Grant/Funding Number | General Mills |
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| Name | Class |
|---|---|
| General Mills | INDUSTRY |
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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. |
|
| 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 |
|---|---|---|
| Changes in body weight | Measured on digital scale at final visit. | week 16 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose | Serum glucose will be measured in a fasted state. | week 16 visit |
| Change in hemoglobin A1c | A1c is a measure of average glucose over the previous 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fat mass | As measured by bioelectrical impedance analysis (BIA) on the InBody S10 body composition analyzer. | week 16 visit |
| Changes in lipids | Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Wyatt, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Highlands Family and Community Medicine Clinic | Birmingham | Alabama | 35205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40763896 | Derived | Ellison KM, El Zein A, Baidwan NK, Ferguson CC, Fowler LA, Bryan DR, Reynolds C, Hermanson D, Berg KJ, Mehta T, Hill JO, Wyatt HR, Sayer RD. Adaptive dietary and exercise strategies for weight loss in Adults with Prediabetes Trial (ADAPT): a sequential multiple assignment randomized trial. Am J Clin Nutr. 2025 Oct;122(4):1093-1102. doi: 10.1016/j.ajcnut.2025.07.034. Epub 2025 Aug 7. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
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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. |
|
| week 16 visit |
| Change in insulin | Serum insulin will be measured in a fasted state. | week 16 visit |
| Changes in QUICKI index | Predictor of insulin resistance that will be calculated from glucose and insulin measures | week 16 visit |
| week 16 visit |
| Change in Blood Pressure | Measured with a clinical grade blood pressure cuff. | week 16 visit |
| Changes in body weight | Measured on digital scale in order to determine "responder" or "non-responder" status. | week 4 visit |
| Changes in aerobic fitness | As measured by the 3-minute step test. | week 16 visit |
| Changes in overall strength | As measured by hand grip dynamometry | week 16 visit |
| Diet Intake and Physical Activity Monitoring | 7-day food logs and weekly physical activity logs | week 16 visit |
| Diet Intake and Physical Activity Monitoring | 7-day food logs and weekly physical activity logs | week 4 visit |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D000073600 |
| Diet, High-Protein |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |