Disabilities, Obesity and Overweight, Prediabetes
Conditions
Keywords
SMART, diet, exercise, weight loss, disabilities
Brief summary
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.
Interventions
BEHAVIORALHigh 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.
BEHAVIORALReduced Carbohydrate Diet
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years of age * BMI of 27 kg/m2 or greater for ambulatory individuals and 22 kg/m2 for individuals with spinal cord injury. Adjustments will be calculated for those with amputations and/or limb indifference * at risk for developing type 2 diabetes (prediabetes) * One or more physical or mobility disabilities * Stable medication type and dosage for 3 or more months for medications likely to affect body weight and/or appetite * Willing to complete requirements for participation
Exclusion criteria
* Pregnant, planning to become pregnant or breastfeeding * Currently taking medication(s) for weight loss * Medical history of Type 1 or 2 Diabetes, using exogenous insulin, using prescription or OTC weight loss medications within the past 3 months, current alcohol or drug abuse or dependence, smoker with unstable habits in the past 3 months, pacemaker or other life-threatening medical implant, eating disorder(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glucose | Baseline & Week 16 | Serum glucose will be measured in a fasted state. |
| Changes in body weight | Baseline, Week4, and Week 16 | Measured on validated digital scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fat mass | Baseline & Week 16 | As measured by dual-energy X-ray absorptiometry (DEXA) |
| Change in insulin | Baseline & Week 16 | Serum insulin will be measured in a fasted state. |
| Changes in lipids | Baseline & Week 16 | Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol |
| Changes in QUICKI index | Baseline & Week 16 | Predictor of insulin resistance that will be calculated from glucose and insulin measures |
| Changes in overall strength | Baseline & Week 16 | As measured by hand grip dynamometry |
| Changes in aerobic fitness | Baseline & Week 16 | As measured by graded exercise test using arm crank |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Ferguson, PhD
University of Alabama at Birmingham
Outcome results
None listed