DisabilitiesiADAPTNCT06976307
Development of an Inclusive Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
A study testing High Carbohydrate Diet and Reduced Carbohydrate Diet in people with Disabilities and Obesity and Overweight, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disabilities, Obesity and Overweight, Prediabetes
- What is being tested?
- High Carbohydrate Diet and Reduced Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellness Health and Research Facility (WHARF)
Birmingham, Alabama, 35209
About this study
Official title: Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
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.
- Conditions
- Disabilities, Obesity and Overweight, Prediabetes
- Being tested
- High Carbohydrate Diet, Reduced Carbohydrate Diet
- Keywords
- SMART, diet, exercise, weight loss, disabilities
- Medical subject headings
- Obesity, Overweight, Prediabetic State, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Carbohydrate DietBehavioural
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.
Reduced Carbohydrate DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High Carbohydrate Diet |
| 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. Receives: Behavioral: Reduced Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose
Serum glucose will be measured in a fasted state.
Measured: Baseline & Week 16
Changes in body weight
Measured on validated digital scale
Measured: Baseline, Week4, and Week 16
Secondary outcomes (6)
Changes in fat mass
As measured by dual-energy X-ray absorptiometry (DEXA)
Measured: Baseline & Week 16
Change in insulin
Serum insulin will be measured in a fasted state.
Measured: Baseline & Week 16
Changes in lipids
Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol
Measured: Baseline & Week 16
Changes in QUICKI index
Predictor of insulin resistance that will be calculated from glucose and insulin measures
Measured: Baseline & Week 16
Changes in overall strength
As measured by hand grip dynamometry
Measured: Baseline & Week 16
Changes in aerobic fitness
As measured by graded exercise test using arm crank
Measured: Baseline & Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start24 Mar 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisabilitiesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Ferguson, PhD, RD, LD, University of Alabama at Birmingham
- Investigators
- Christine Ferguson, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976307
- Sponsor's protocol ID
- IRB-300006816-sub-study
- Other IDs
- CEDHARS
- Acronym
- iADAPT
- Status last verified
- Jul 2026
- First submitted
- 8 May 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
- ClinicalTrials.gov ID
- NCT06976307
- Acronym / sponsor ID
- iADAPT / IRB-300006816-sub-study
- Conditions
- Disabilities, Obesity and Overweight, Prediabetes
- Keywords
- SMART, diet, exercise, weight loss, disabilities
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Carbohydrate Diet | Experimental | Behavioral: High Carbohydrate DietEnrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan. |
| Reduced Carbohydrate Diet | Experimental | Behavioral: Reduced Carbohydrate DietEnrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Carbohydrate DietParticipants 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. | Behavioural | High Carbohydrate Diet |
| Reduced Carbohydrate DietParticipants 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. | Behavioural | Reduced Carbohydrate Diet |
Primary outcome
Change in glucose
Time frame: Baseline & Week 16
Serum glucose will be measured in a fasted state.
Changes in body weight
Time frame: Baseline, Week4, and Week 16
Measured on validated digital scale
6 secondary outcomes
Changes in fat mass
Time frame: Baseline & Week 16
Change in insulin
Time frame: Baseline & Week 16
Changes in lipids
Time frame: Baseline & Week 16
Changes in QUICKI index
Time frame: Baseline & Week 16
Changes in overall strength
Time frame: Baseline & Week 16
Changes in aerobic fitness
Time frame: Baseline & Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Ferguson, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Carbohydrate Diet and Reduced Carbohydrate Diet in people with Disabilities and Obesity and Overweight, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose (time frame: Baseline & Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.