PreDiabetesNCT04745572
Development of an Adaptive Treatment for Weight Loss in People With Prediabetes
A study testing High Carbohydrate Diet and Reduced Carbohydrate Diet in people with PreDiabetes and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Obesity
- 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
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 21 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- BMI of 27 kg/m2 or greater
- at risk for developing type 2 diabetes (prediabetes)
Who cannot join
- Pregnant, planning to become pregnant, or breastfeeding
- uncontrolled hypo or hyperthyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Highlands Family and Community Medicine Clinic
Birmingham, Alabama, 35205
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 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
- PreDiabetes, Obesity
- Being tested
- High Carbohydrate Diet, Reduced Carbohydrate Diet
- Keywords
- weight loss, reduced carbohydrate diet, exercise training, time restricted eating
- Medical subject headings
- Prediabetic State, Obesity, Weight Loss, Intermittent Fasting
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.
Changes in body weight
Measured on digital scale at final visit.
Measured: week 16 visit
Secondary outcomes (4)
Change in glucose
Serum glucose will be measured in a fasted state.
Measured: week 16 visit
Change in hemoglobin A1c
A1c is a measure of average glucose over the previous 3 months.
Measured: week 16 visit
Change in insulin
Serum insulin will be measured in a fasted state.
Measured: week 16 visit
Changes in QUICKI index
Predictor of insulin resistance that will be calculated from glucose and insulin measures
Measured: week 16 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start14 May 2021
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Principal investigator, Holly Wyatt, University of Alabama at Birmingham
- Investigators
- Holly Wyatt, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745572
- Sponsor's protocol ID
- IRB-300006816
- Other IDs
- General Mills
- Status last verified
- Oct 2024
- First submitted
- 4 Feb 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40763896
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. 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
- NCT04745572
- Acronym / sponsor ID
- IRB-300006816
- Conditions
- PreDiabetes, Obesity
- Keywords
- weight loss, reduced carbohydrate diet, exercise training, time restricted eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- 14 May 2021 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 9 Feb 2021 (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 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years of age
- BMI of 27 kg/m2 or greater
- at risk for developing type 2 diabetes (prediabetes)
Key exclusion criteria (2 listed)
- Pregnant, planning to become pregnant, or breastfeeding
- uncontrolled hypo or hyperthyroidism
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
Changes in body weight
Time frame: week 16 visit
Measured on digital scale at final visit.
4 secondary outcomes
Change in glucose
Time frame: week 16 visit
Change in hemoglobin A1c
Time frame: week 16 visit
Change in insulin
Time frame: week 16 visit
Changes in QUICKI index
Time frame: week 16 visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 40763896Ellison 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.
- 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.
Holly Wyatt, MD 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 PreDiabetes and Obesity, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in body weight (time frame: week 16 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04745572, which also lists 1 linked publication.
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 27 Apr 2025.