PreDiabetes, Weight Loss
Conditions
Keywords
community pharmacy
Brief 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 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..
Interventions
BEHAVIORALModified 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.
Sponsors
Auburn University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥18 years old * BMI ≥ 25kg/m2 (23 if Asian)
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 6 months | Change from baseline body weight |
| Change in A1c | 3- and 6- months | Change from baseline A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity change | 6 months | Change from baseline self-reported physical activity in minutes per week |
| Proportion of patients meeting DPP program criteria | From enrollment, assessed once enrollment is complete, within 3 months of study start. | Percentage of individuals meeting DPP criteria at baseline |
| Blood pressure change | 6 months | Change from baseline blood pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Stage of Change for Weight Loss | 6 months | Change from baseline in stage of change (scale 1-5; 1= precontemplation, 2= contemplation, 3= preparation, 4= action, 5= maintenance) |
| Change in Processes of Change for Weight Loss including the following processes: emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions | 6 months | Change from baseline in process of change (scale 0 to 100; higher = more active use of the process of change) |
| Participation and attrition | 6 months | Rate of participation and attrition |
| Reasons for participation/non-participation | 1 year | Qualitative analysis through semi-structured interview |
| Change in level of confidence in ability to motivate oneself to maintain dietary and physical activity behaviors for at least 6 months | 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 |
Countries
United States
Outcome results
None listed