scholarly journals Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Natalie D Ritchie ◽  
Jodi Summers Holtrop ◽  
R Mark Gritz ◽  
Katherine Ann Sauder ◽  
Michael Josh Durfee ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Low Income ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Diabetes Prevention Program ◽  
Evidence Based ◽  
Randomized Controlled

BACKGROUND Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov. OBJECTIVE This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment. METHODS This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery. RESULTS This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024. CONCLUSIONS This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country. CLINICALTRIAL ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/15499

scholarly journals Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial

10.2196/15499 ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. e15499
Author(s):  
Natalie D Ritchie ◽  
Jodi Summers Holtrop ◽  
R Mark Gritz ◽  
Katherine Ann Sauder ◽  
Michael Josh Durfee ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Low Income ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Diabetes Prevention Program ◽  
Evidence Based ◽  
Randomized Controlled

Background Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov. Objective This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment. Methods This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery. Results This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024. Conclusions This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country. Trial Registration ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499. International Registered Report Identifier (IRRID) PRR1-10.2196/15499

Randomized Controlled Trial of Technology-Assisted Case Management in Low-Income Adults with Type 2 Diabetes

2017 ◽  
Vol 19 (8) ◽  
pp. 476-482 ◽  
Author(s):  
Leonard E. Egede ◽  
Joni S. Williams ◽  
Delia C. Voronca ◽  
Rebecca G. Knapp ◽  
Jyotika K. Fernandes
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Case Management ◽  
Low Income ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Cost-Efficacy of Surgically Induced Weight Loss for the Management of Type 2 Diabetes: A randomized controlled trial

Diabetes Care ◽  
2009 ◽  
Vol 32 (4) ◽  
pp. 580-584 ◽  
Author(s):  
C. L. Keating ◽  
J. B. Dixon ◽  
M. L. Moodie ◽  
A. Peeters ◽  
J. Playfair ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Cost Efficacy ◽  
Surgically Induced

scholarly journals Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Tatiana Toro-Ramos ◽  
Andreas Michaelides ◽  
Maria Anton ◽  
Zulekha Karim ◽  
Leah Kang-Oh ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Prevention Program ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Control Group ◽  
Significant Weight Loss ◽  
Randomized Controlled

BACKGROUND The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). OBJECTIVE This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. METHODS Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA<sub>1c</sub> levels. RESULTS A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA<sub>1c</sub> levels (mean difference 0.004%, SE 0.05; <i>P</i>=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; <i>P</i>&lt;.001) and −0.99 kg/m2 (SE 0.29; <i>P</i>=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; <i>P</i>&lt;.001) at 6 months, maintaining 4.7% (SE 0.88; <i>P</i>&lt;.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; <i>P</i>=.85) and gained 0.33% (SE 0.70; <i>P</i>=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA<sub>1c</sub> level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA<sub>1c</sub> levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA<sub>1c</sub> levels. CONCLUSIONS This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. CLINICALTRIAL ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342

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