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

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

10.2196/17842 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e17842
Author(s):  
Tatiana Toro-Ramos ◽  
Andreas Michaelides ◽  
Maria Anton ◽  
Zulekha Karim ◽  
Leah Kang-Oh ◽  
...  
Keyword(s):  
Weight Loss ◽  
Prevention Program ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Control Group ◽  
Significant Weight Loss ◽  
Randomized Controlled ◽  
Hba1c Levels

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 A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c 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 HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; P<.001) and −0.99 kg/m2 (SE 0.29; P=.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; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c 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. Trial Registration ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342

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 The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) program: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kar-Fu Yeung ◽  
Mihir Gandhi ◽  
Amanda Yun Rui Lam ◽  
Selly Julianty ◽  
Alvin Yeow Meng Chia ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Plasma Glucose ◽  
Prevention Program ◽  
Financial Incentives ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Diabetes Prevention Program ◽  
Community Based ◽  
Randomized Controlled

Abstract Background Community-based diabetes prevention programs varied widely in effectiveness, and the intervention strategy consisting of lifestyle interventions, stepwise addition of metformin, and financial incentives has not been studied in real-world clinical practice settings. The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) trial is a pragmatic trial that aims to compare the effectiveness of a community-based stepwise diabetes prevention program with added financial incentives (intervention) versus the standard of care (control) in reducing the risk of type 2 diabetes over 3 years among overweight or obese individuals with pre-diabetes. Methods This is an open-label, 1:1 randomized controlled trial which aims to recruit 846 adult individuals with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or both IFG and IGT from Singapore. Intervention arm participants attend 12 group-based sessions (2 nutrition workshops, 9 exercise sessions, and a goal-setting workshop) delivered at community sites (weeks 1 to 6), receive weekly physical activity and nutrition recommendations delivered by printed worksheets (weeks 7 to 12), and receive monthly health tips delivered by text messages (months 4 to 36). From month 6 onwards, intervention arm participants who remain at the highest risk of conversion to diabetes are prescribed metformin. Intervention arm participants are also eligible for a payment/rewards program with incentives tied to attendance at the group sessions and achievement of the weight loss target (5% of baseline weight). All participants are assessed at baseline, month 3, month 6, and every 6 months subsequently till month 36. The primary endpoint is the proportion of participants with diabetes at 3 years. Secondary endpoints include the mean change from baseline at 3 years in fasting plasma glucose, 2-hour plasma glucose, HbA1c, body weight, body mass index, physical activity, and dietary intake. Discussion The Pre-DICTED trial will provide evidence of the effectiveness and feasibility of a community-based stepwise diabetes prevention program with added financial incentives for individuals with pre-diabetes in Singapore. The study will provide data for a future cost-effectiveness analysis, which will be used to inform policymakers of the value of a nationwide implementation of the diabetes prevention program. Trial registration ClinicalTrials.govNCT03503942. Retrospectively registered on April 20, 2018. Protocol version: 5.0 Date: 1 March 2019

scholarly journals Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Simon Driver ◽  
Chad Swank ◽  
Katherine Froehlich-Grobe ◽  
Evan McShan ◽  
Stephanie Calhoun ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Emotional Disorders ◽  
Cerebrovascular Accident ◽  
Recurrent Stroke ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Weight gain can be a consequence of stroke, or cerebrovascular accident (CVA), because of impaired mobility, behavioral and emotional disorders, and sensory losses. Weight gain increases the patient’s risk of recurrent stroke and chronic diseases, such as diabetes, metabolic syndrome, and pulmonary and heart disease. Approaches to weight loss in this population are lacking, although necessary because of the unique physiological and cognitive needs of persons after a stroke. Evidence shows that intensive behavioral therapy interventions that address both physical activity and diet offer the greatest potential for weight loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight loss program that has been used extensively with the general population; this program was modified to meet the needs of people who have had a stroke (GLB-CVA). OBJECTIVE This randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with that of a waitlist control group. METHODS This RCT will enroll and randomize 64 patients over an 18-month period. RESULTS Currently, 51 people are waitlisted, with 23 out of 51 screened and 16 out of 23 eligible. CONCLUSIONS It is anticipated that the findings from this RCT will contribute to the evidence base regarding weight loss strategies for people living with stroke. CLINICALTRIAL ClinicalTrials.gov NCT03873467; https://clinicaltrials.gov/ct2/show/NCT03873467. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14338

The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Kar-Fu Yeung ◽  
Mihir Gandhi ◽  
Amanda Yun Rui Lam ◽  
Selly Julianty ◽  
Alvin Yeow Meng Chia ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Plasma Glucose ◽  
Prevention Program ◽  
Financial Incentives ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Diabetes Prevention Program ◽  
Community Based ◽  
Randomized Controlled

Abstract BackgroundCommunity-based diabetes prevention programs varied widely in effectiveness, and the intervention strategy consisting of lifestyle interventions, stepwise addition of metformin and financial incentives has not been studied in real-world clinical practice settings. The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) trial is a pragmatic trial that aims to compare the effectiveness of a community-based stepwise diabetes prevention program with added financial incentives (intervention) versus the standard of care (control) in reducing the risk of type 2 diabetes over 3 years among overweight or obese individuals with pre-diabetes. MethodsThis is an open-label, 1:1 randomized controlled trial which aims to recruit 846 adult individuals with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or both IFG and IGT from Singapore. Intervention arm participants attend 12 group-based sessions (2 nutrition workshops, 9 exercise sessions and a goal-setting workshop) delivered at community sites (weeks 1 to 6), receive weekly physical activity and nutrition recommendations delivered by printed worksheets (weeks 7 to 12), and receive monthly health tips delivered by text messages (months 4 to 36). From month 6 onwards, intervention arm participants who remain at the highest risk of conversion to diabetes are prescribed metformin. Intervention arm participants are also eligible for a payment/rewards program with incentives tied to attendance at the group sessions and achievement of the weight loss target (5% of baseline weight). All participants are assessed at baseline, month 3, month 6, and every 6 months subsequently till month 36. The primary endpoint is the proportion of participants with diabetes at 3 years. Secondary endpoints include the mean change from baseline at 3 years in fasting plasma glucose, 2-hour plasma glucose, HbA1c, body weight, body mass index, physical activity and dietary intake. DiscussionThe Pre-DICTED trial will provide evidence of the effectiveness and feasibility of a community-based stepwise diabetes prevention program with added financial incentives for individuals with pre-diabetes in Singapore. The study will provide data for a future cost-effectiveness analysis, which will be used to inform policymakers of the value of a nationwide implementation of the diabetes prevention program.Trial registrationClinicalTrials.gov ID: NCT03503942; April 20, 2018 retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03503942Protocol version: 5.0 Date: 1 March 2019

scholarly journals A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012–2014

2015 ◽  
Vol 12 ◽  
Author(s):  
Kellie R. Weinhold ◽  
Carla K. Miller ◽  
David G. Marrero ◽  
Haikady N. Nagaraja ◽  
Brian C. Focht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Prevention Program ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Diabetes Prevention Program ◽  
Randomized Controlled
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