Diabetes Prevention Program to Treat Overweight and Obesity (DPP-TOO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Weight Loss; PreDiabetes
• Intervention / Treatment: Behavioral: Modified Diabetes Prevention Program Curriculum

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥18 years old
• BMI ≥ 25kg/m2 (23 if Asian)

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified DPP; Participants in this arm will participate in the modified Diabetes Prevention Program curriculum.	Behavioral: Modified Diabetes Prevention Program Curriculum; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Change from baseline body weight	6 months
Change in A1c	Change from baseline A1c	3- and 6- months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients meeting DPP program criteria	Percentage of individuals meeting DPP criteria at baseline	From enrollment, assessed once enrollment is complete, within 3 months of study start.
Blood pressure change	Change from baseline blood pressure	6 months
Physical activity change	Change from baseline self-reported physical activity in minutes per week	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation and attrition	Rate of participation and attrition	6 months
Reasons for participation/non-participation	Qualitative analysis through semi-structured interview	1 year
Change in level of confidence in ability to motivate oneself to maintain dietary and physical activity behaviors for at least 6 months	Change from baseline in level of confidence in motivating oneself to engage the included dietary and physical behaviors for at lease six months as assessed by "Self-efficacy for diet and exercise behaviors" tool. Domains include sticking to an exercise regimen, making time for exercise, sticking to a diet, reducing calories, reducing salt, and reducing fat. Scale 1 to 5; higher = more confident	6 months
Change in Stage of Change for Weight Loss	Change from baseline in stage of change (scale 1-5; 1= precontemplation, 2= contemplation, 3= preparation, 4= action, 5= maintenance)	6 months
Change in Processes of Change for Weight Loss including the following processes: emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions	Change from baseline in process of change (scale 0 to 100; higher = more active use of the process of change)	6 months

Collaborators and Investigators

• Sponsor: Auburn University

Publications and helpful links

General 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.
• Venkataramani 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.
• Joiner 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.
• Martin 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.
• Sallis 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.
• Andres 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.

Helpful Links

• National Diabetes Statistics Report
• CDC Nutrition, Physical Activity, and Obesity: Data, Trends and Maps
• NIH Diabetes Prevention Program
• CDC National Diabetes Prevention Program
• National Diabetes Prevention Program Curricula
• RX for the National Diabetes Prevention Program
• Prediabetes Risk Test

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: community pharmacy
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 22-254 EP 2207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No