Weight LossDPP-TOONCT05640869
Diabetes Prevention Program to Treat Overweight and Obesity
A study testing Modified Diabetes Prevention Program Curriculum in people with Weight Loss and PreDiabetes, run by Auburn University at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the efficacy of the diabetes prevention program for the treatment of overweight and obesity within the community pharmacy setting. The long-term goal is to demonstrate the potential to improve diabetes prevention efforts through expanded access to weight loss services… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, PreDiabetes
- What is being tested?
- Modified Diabetes Prevention Program Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- BMI ≥ 25kg/m2 (23 if Asian)
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diabetes Prevention Program to Treat Overweight and Obesity
The purpose of this study is to demonstrate the efficacy of the diabetes prevention program for the treatment of overweight and obesity within the community pharmacy setting. The long-term goal is to demonstrate the potential to improve diabetes prevention efforts through expanded access to weight loss services provided in community pharmacies.
Read the detailed description
An estimated 38% percent of U.S. adults currently has prediabetes. In individuals aged 65 years and older, the prevalence of prediabetes is 48.8%. Prediabetes is commonly a precursor to the development of type 2 diabetes (t2d). Approximately 5-10% of individuals with prediabetes progress to t2d annually, with 70% developing t2d within their lifetime. Obesity is a significant risk factor for both prediabetes and diabetes, and its prevalence is steadily increasing. In 2020, a combined 66.7% of U.S. adults were classified as overweight or obese. In individuals with prediabetes, interventions leading to a 5-10% decrease in baseline body weight decrease the risk for progression to t2d by 58% at three years and 71% for those aged 60 years and older. At ten and fifteen years, the risk was decreased by 34% and 27%, respectively, and diabetes progression was significantly delayed. Based on these findings, a structured lifestyle intervention program was developed and has been available for public use by the Centers for Disease Control and Prevention (CDC) since 2010. Despite significant resources for the implementation of the Diabetes Prevention Program (DPP), program dissemination and utilization remains low. There are currently 1,882 registered DPP providers nationwide. Due to the modest results attributed to significant efforts to increase the access to and participation in DPP programs across the country, consideration should be given to modifying the current approach to diabetes prevention efforts.
In 2020, approximately 42.4% of American adults had obesity according to the 2021 State of Obesity: Better Policies for a Healthier America report. The prevalence of obesity has been steadily increasing for the last two decades. This upward trend is expected to continue this if effective and sustainable solutions are not employed. According to the CDC, in 2013-2016, 49.1% of adults reported having tried to lose weight within the last year. Searching "weight loss" in any internet browser will return over a billion results ranging from diet plans and weight loss programs to testimonials of individual weight loss journeys. Due to the prevalence of overweight and obesity, the demand for weight loss interventions, and the efficacy of weight reduction for decreasing the risk for t2d development, expanding access to evidence-based weight loss interventions has the potential to significantly advance diabetes prevention efforts nationwide by shifting the focus from preventing prediabetes to treating overweight and obesity. One major gap in the current treatment landscape is how to implement an effective program for adult weight loss with widespread impact.
Given the prevalence and visibility of community pharmacies, this setting is ideal for the dissemination of weight management services. In order to assess the potential impact, this pilot study aims to implement a modified-DPP program and to assess the diabetes risk and health outcomes of individuals choosing to participate in the program..
- Conditions
- Weight Loss, PreDiabetes
- Being tested
- Modified Diabetes Prevention Program Curriculum
- Keywords
- community pharmacy
- Medical subject headings
- Weight Loss, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Diabetes Prevention Program CurriculumBehavioural
The modified DPP curriculum will be an exact copy of the current DPP curriculum except that references to the prevention of diabetes will be modified to prevention of health outcomes associated with overweight/obesity and/or management of overweight/obesity.
| Study group | Role | What they receive |
|---|---|---|
| Modified DPP | Experimental | Participants in this arm will participate in the modified Diabetes Prevention Program curriculum. Receives: Behavioral: Modified Diabetes Prevention Program Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Change from baseline body weight
Measured: 6 months
Change in A1c
Change from baseline A1c
Measured: 3- and 6- months
Secondary outcomes (3)
Proportion of patients meeting DPP program criteria
Percentage of individuals meeting DPP criteria at baseline
Measured: From enrollment, assessed once enrollment is complete, within 3 months of study start.
Blood pressure change
Change from baseline blood pressure
Measured: 6 months
Physical activity change
Change from baseline self-reported physical activity in minutes per week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start7 Feb 2023
- Primary completion1 Aug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney E Gamston, Auburn University
- Investigators
- Courtney E Gamston, PharmD, Principal investigator, Auburn University Harrison School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640869
- Sponsor's protocol ID
- 22-254 EP 2207
- Acronym
- DPP-TOO
- Status last verified
- Apr 2023
- First submitted
- 22 Aug 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
PubMed 22683128Venkataramani M, Pollack CE, Yeh HC, Maruthur NM. Prevalence and Correlates of Diabetes Prevention Program Referral and Participation. Am J Prev Med. 2019 Mar;56(3):452-457. doi: 10.1016/j.amepre.2018.10.005. Epub 2019 Jan 17.
PubMed 30661888Joiner KL, McEwen LN, Hurst TE, Adams MP, Herman WH. Domains from the health belief model predict enrollment in the National Diabetes Prevention Program among insured adults with prediabetes. J Diabetes Complications. 2022 Jul;36(7):108220. doi: 10.1016/j.jdiacomp.2022.108220. Epub 2022 May 17.
PubMed 35613987Martin CB, Herrick KA, Sarafrazi N, Ogden CL. Attempts to Lose Weight Among Adults in the United States, 2013-2016. NCHS Data Brief. 2018 Jul;(313):1-8.
PubMed 30044214Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
PubMed 3432232Andres A, Saldana C, Gomez-Benito J. Establishing the stages and processes of change for weight loss by consensus of experts. Obesity (Silver Spring). 2009 Sep;17(9):1717-23. doi: 10.1038/oby.2009.100. Epub 2009 Apr 9.
PubMed 19360014
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diabetes Prevention Program to Treat Overweight and Obesity
- ClinicalTrials.gov ID
- NCT05640869
- Acronym / sponsor ID
- DPP-TOO / 22-254 EP 2207
- Conditions
- Weight Loss, PreDiabetes
- Keywords
- community pharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Dec 2022 (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.
The purpose of this study is to demonstrate the efficacy of the diabetes prevention program for the treatment of overweight and obesity within the community pharmacy setting. The long-term goal is to demonstrate the potential to improve diabetes prevention efforts through expanded access to weight loss services provided in community pharmacies.
Detailed description
An estimated 38% percent of U.S. adults currently has prediabetes. In individuals aged 65 years and older, the prevalence of prediabetes is 48.8%. Prediabetes is commonly a precursor to the development of type 2 diabetes (t2d). Approximately 5-10% of individuals with prediabetes progress to t2d annually, with 70% developing t2d within their lifetime. Obesity is a significant risk factor for both prediabetes and diabetes, and its prevalence is steadily increasing. In 2020, a combined 66.7% of U.S. adults were classified as overweight or obese. In individuals with prediabetes, interventions leading to a 5-10% decrease in baseline body weight decrease the risk for progression to t2d by 58% at three years and 71% for those aged 60 years and older. At ten and fifteen years, the risk was decreased by 34% and 27%, respectively, and diabetes progression was significantly delayed. Based on these findings, a structured lifestyle intervention program was developed and has been available for public use by the Centers for Disease Control and Prevention (CDC) since 2010. Despite significant resources for the implementation of the Diabetes Prevention Program (DPP), program dissemination and utilization remains low. There are currently 1,882 registered DPP providers nationwide. Due to the modest results attributed to significant efforts to increase the access to and participation in DPP programs across the country, consideration should be given to modifying the current approach to diabetes prevention efforts.
In 2020, approximately 42.4% of American adults had obesity according to the 2021 State of Obesity: Better Policies for a Healthier America report. The prevalence of obesity has been steadily increasing for the last two decades. This upward trend is expected to continue this if effective and sustainable solutions are not employed. According to the CDC, in 2013-2016, 49.1% of adults reported having tried to lose weight within the last year. Searching "weight loss" in any internet browser will return over a billion results ranging from diet plans and weight loss programs to testimonials of individual weight loss journeys. Due to the prevalence of overweight and obesity, the demand for weight loss interventions, and the efficacy of weight reduction for decreasing the risk for t2d development, expanding access to evidence-based weight loss interventions has the potential to significantly advance diabetes prevention efforts nationwide by shifting the focus from preventing prediabetes to treating overweight and obesity. One major gap in the current treatment landscape is how to implement an effective program for adult weight loss with widespread impact.
Given the prevalence and visibility of community pharmacies, this setting is ideal for the dissemination of weight management services. In order to assess the potential impact, this pilot study aims to implement a modified-DPP program and to assess the diabetes risk and health outcomes of individuals choosing to participate in the program..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified DPP | Experimental | Behavioral: Modified Diabetes Prevention Program CurriculumParticipants in this arm will participate in the modified Diabetes Prevention Program curriculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years old
- BMI ≥ 25kg/m2 (23 if Asian)
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Modified Diabetes Prevention Program CurriculumThe modified DPP curriculum will be an exact copy of the current DPP curriculum except that references to the prevention of diabetes will be modified to prevention of health outcomes associated with overweight/obesity and/or management of overweight/obesity. | Behavioural | Modified DPP |
Primary outcome
Weight loss
Time frame: 6 months
Change from baseline body weight
Change in A1c
Time frame: 3- and 6- months
Change from baseline A1c
3 secondary outcomes
Proportion of patients meeting DPP program criteria
Time frame: From enrollment, assessed once enrollment is complete, within 3 months of study start.
Blood pressure change
Time frame: 6 months
Physical activity change
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 22683128Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
- Background: PubMed 30661888Venkataramani M, Pollack CE, Yeh HC, Maruthur NM. Prevalence and Correlates of Diabetes Prevention Program Referral and Participation. Am J Prev Med. 2019 Mar;56(3):452-457. doi: 10.1016/j.amepre.2018.10.005. Epub 2019 Jan 17.
- Background: PubMed 35613987Joiner KL, McEwen LN, Hurst TE, Adams MP, Herman WH. Domains from the health belief model predict enrollment in the National Diabetes Prevention Program among insured adults with prediabetes. J Diabetes Complications. 2022 Jul;36(7):108220. doi: 10.1016/j.jdiacomp.2022.108220. Epub 2022 May 17.
- Background: PubMed 30044214Martin CB, Herrick KA, Sarafrazi N, Ogden CL. Attempts to Lose Weight Among Adults in the United States, 2013-2016. NCHS Data Brief. 2018 Jul;(313):1-8.
- Background: PubMed 3432232Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
- Background: PubMed 19360014Andres A, Saldana C, Gomez-Benito J. Establishing the stages and processes of change for weight loss by consensus of experts. Obesity (Silver Spring). 2009 Sep;17(9):1717-23. doi: 10.1038/oby.2009.100. Epub 2009 Apr 9.
- National Diabetes Statistics ReportLink provided by the sponsor.
- NIH Diabetes Prevention ProgramLink provided by the sponsor.
- National Diabetes Prevention Program CurriculaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Weight Loss
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Active, not recruiting
A Multidisciplinary Weight Loss Program at AUB-MC
Obesity, Weight Loss
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
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.
Courtney E Gamston, PharmD principal investigator
Auburn University Harrison School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Diabetes Prevention Program Curriculum in people with Weight Loss and PreDiabetes, run by Auburn University 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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?
Results are not available in the source record.
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?
Weight loss (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT05640869, which also lists 6 linked publications.
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 25 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.