scholarly journals Culturally tailored lifestyle interventions for the prevention and management of type 2 diabetes in adults of Black African ancestry: a systematic review of tailoring methods and their effectiveness

2021 ◽  
pp. 1-15
Author(s):  
Noor M Wadi ◽  
Summor Asantewa-Ampaduh ◽  
Carol Rivas ◽  
Louise M Goff
Keyword(s):  
Type 2 Diabetes ◽  
Controlled Trial ◽  
African Ancestry ◽  
Glycated Haemoglobin ◽  
Lifestyle Interventions ◽  
Black African ◽  
Management Interventions ◽  
Culturally Tailored ◽  
Cultural Tailoring

Abstract Objective: To evaluate the cultural tailoring methods used in type 2 diabetes (T2D), prevention and management interventions for populations of Black African ancestry and to examine their effectiveness on measures of glycaemia. Design: Three databases were searched in October 2020; eligible studies used a randomised controlled trial (RCT) design to evaluate the effectiveness of culturally tailored lifestyle interventions compared with usual care for the prevention or management of T2D in adults of Black African ancestry. Cultural tailoring methods were evaluated using the Facilitator-Location-Language-Messaging (FiLLM) framework, whereby facilitator refers to delivery by individuals from the target community, language focuses on using native language or language appropriate to literacy levels, location refers to delivery in meaningful settings, and messaging is tailoring with relevant content and modes of delivery. Results: Sixteen RCT were identified, all from USA. The mean age of participants was 55 years, majority female. Six of fifteen RCT reported significant improvements in glycated haemoglobin (HbA1c) at 6 and 8 months; one, in prediabetes, reported significantly improved fasting plasma glucose. Diabetes knowledge improvement (5/7 studies) was associated with HbA1c improvement. The majority tailored to location (12/16), facilitators (11/16), messaging (9/16) and language (6/16) domains of FiLLM. Those with ethnically matched facilitators and those which tailored to more than one domain showed the greatest HbA1C benefits. Conclusion: This evidence supports the effectiveness of culturally tailored lifestyle interventions for T2D management in populations of Black African ancestry, with further RCT needed to evaluate interventions for T2D prevention and for communities outside of the USA.

scholarly journals Salud paso por paso : a culturally-tailored physical activity intervention with hispanic adults with type 2 diabetes mellitus

2021 ◽  
Author(s):  
◽  
Julio Cesar Loya
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Culturally Tailored ◽  
Hispanic Adults

Limited information is available regarding culturally-tailored physical activity (PA) interventions for Hispanic adults with type 2 diabetes mellitus (T2DM). A community-partnered approach was used to examine a novel culturally-tailored PA intervention using a pre-post, no control group design. The intervention consisted of six weekly 45-minute sessions for participants to engage in PA led by the researcher. A total of 21 individuals participated in the study. The typical participant was a 53-year-old female (90 percent) Hispanic adult living with T2DM with low acculturation. On average, before the intervention, the participants walked 10,285 (sd 14,779) steps per week with 43.4 (sd 68.1) minutes of PA per week. Despite implementation during the COVID-19 pandemic, the intervention was feasible and acceptable, and 19 (90.5 percent) participants attended all intervention sessions. There were significant increases in steps per week (p=0.007; d=1.03) and minutes of PA per week (p=0.000; d=1.62). Findings suggest that Salud Paso por Paso has promise as a strategy to enhance PA behaviors in the priority population. A randomized, controlled trial with a larger study sample is warranted to examine efficacy and impact on the diabetes health outcomes of Hispanic adults with T2DM.

scholarly journals Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study)

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Yifei Zhang ◽  
Yanyun Gu ◽  
Huahui Ren ◽  
Shujie Wang ◽  
Huanzi Zhong ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Oral Intake ◽  
Glycated Haemoglobin ◽  
Double Blind ◽  
Promising Target ◽  
Bacteriostatic Agent ◽  
Gastrointestinal Side Effects

Abstract Human gut microbiome is a promising target for managing type 2 diabetes (T2D). Measures altering gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis. We hence conducted a randomized, double-blind, placebo-controlled trial with newly diagnosed T2D patients from 20 centres in China. Four-hundred-nine eligible participants were enroled, randomly assigned (1:1:1:1) and completed a 12-week treatment of either BBR-alone, probiotics+BBR, probiotics-alone, or placebo, after a one-week run-in of gentamycin pretreatment. The changes in glycated haemoglobin, as the primary outcome, in the probiotics+BBR (least-squares mean [95% CI], −1.04[−1.19, −0.89]%) and BBR-alone group (−0.99[−1.16, −0.83]%) were significantly greater than that in the placebo and probiotics-alone groups (−0.59[−0.75, −0.44]%, −0.53[−0.68, −0.37]%, P < 0.001). BBR treatment induced more gastrointestinal side effects. Further metagenomics and metabolomic studies found that the hypoglycaemic effect of BBR is mediated by the inhibition of DCA biotransformation by Ruminococcus bromii. Therefore, our study reports a human microbial related mechanism underlying the antidiabetic effect of BBR on T2D. (Clinicaltrial.gov Identifier: NCT02861261).

scholarly journals Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Marja Harjumaa ◽  
Pilvikki Absetz ◽  
Miikka Ermes ◽  
Elina Mattila ◽  
Reija Männikkö ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Control Group ◽  
User Engagement ◽  
Lifestyle Interventions ◽  
Randomized Controlled ◽  
Healthy Habits ◽  
Internet Based Intervention

BACKGROUND Type 2 diabetes can be prevented through lifestyle changes, but sustainable and scalable lifestyle interventions are still lacking. Habit-based approaches offer an opportunity to induce long-term behavior changes. OBJECTIVE The purposes of this study were to describe an internet-based lifestyle intervention for people at risk for type 2 diabetes targeted to support formation of healthy habits and explore its user engagement during the first 6 months of a randomized controlled trial (RCT). METHODS The app provides an online store that offers more than 400 simple and contextualized habit-forming behavioral suggestions triggered by daily life activities. Users can browse, inspect, and select them; report their performances; and reflect on their own activities. Users can also get reminders, information on other users’ activities, and information on the prevention of type 2 diabetes. An unblended parallel RCT was carried out to evaluate the effectiveness of the app in comparison with routine care. User engagement is reported for the first 6 months of the trial based on the use log data of the participants, who were 18- to 70-year-old community-dwelling adults at an increased risk of type 2 diabetes. RESULTS Of 3271 participants recruited online, 2909 were eligible to participate in the RCT. Participants were randomized using a computerized randomization system to the control group (n=971), internet-based intervention (digital, n=967), and internet-based intervention with face-to-face group coaching (F2F+digital, n=971). Mean age of control group participants was 55.0 years, digital group 55.2 years, and F2F+digital 55.2 years. The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group. Of the participants allocated to the digital and F2F+digital groups, 99.53% (1929/1938) logged in to the app at least once, 98.55% (1901/1938) selected at least one habit, and 95.13% (1835/1938) reported at least one habit performance. The app was mostly used on a weekly basis. During the first 6 months, the number of active users on a weekly level varied from 93.05% (1795/1929) on week 1 to 51.79% (999/1929) on week 26. The daily use activity was not as high. The digital and F2F+digital groups used the app on a median of 23.0 and 24.5 days and for 79.4 and 85.1 minutes total duration, respectively. A total of 1,089,555 habit performances were reported during the first 6 months. There were no significant differences in the use metrics between the groups with regard to cumulative use metrics. CONCLUSIONS Results demonstrate that internet-based lifestyle interventions can be delivered to large groups including community-dwelling middle-aged and older adults, many with limited experience in digital app use, without additional user training. This intermediate analysis of use behavior showed relatively good engagement, with the percentage of active weekly users remaining over 50% at 6 months. However, we do not yet know if the weekly engagement was enough to change the lifestyles of the participants. CLINICALTRIAL ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478

scholarly journals The effect of individual and mixed rewards on diabetes management: A feasibility randomized controlled trial

2018 ◽  
Vol 3 ◽  
pp. 139
Author(s):  
J. Jaime Miranda ◽  
María Lazo-Porras ◽  
Antonio Bernabe-Ortiz ◽  
M. Amalia Pesantes ◽  
Francisco Diez-Canseco ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Glycated Haemoglobin ◽  
Economic Incentives ◽  
Controlled Study ◽  
Randomized Controlled

Background: Incentives play a role in introducing health-related benefits, but no interventions using mixed incentives, i.e. a combination of individual and group incentives, have been tested in individuals with type 2 diabetes mellitus (T2DM). We evaluated the feasibility of implementing individual- and mixed-incentives, with and without a supportive partner, on glycated haemoglobin (HbA1c) control and weight loss among patients with T2DM. Methods: This is a feasibility, sex-stratified, single-blinded, randomized controlled study in individuals with T2DM. All participants received diabetes education and tailored goal setting for weight and glycated haemoglobin (HbA1c). Participants were randomly assigned into three arms: individual incentives (Arm 1), mixed incentives-altruism (Arm 2), and mixed incentives-cooperation (Arm 3). Participants were accompanied by a diabetes educator every other week to monitor targets, and the intervention period lasted 3 months. The primary outcome was the change in HbA1c at 3 months from baseline. Weight and change body mass index (BMI) were considered as secondary outcomes. Results: Out of 783 patients screened, a total of 54 participants, 18 per study arm, were enrolled and 44 (82%) completed the 3-month follow-up. Mean baseline HbA1c values were 8.5%, 7.9% and 8.2% in Arm 1, Arm 2, and Arm 3, respectively. At 3 months, participants in all three study arms showed reductions in HbA1c ranging from -0.9% in Arm 2 to -1.4% in Arm 1. Weight and BMI also showed reductions. Conclusions: Individual and mixed cash incentives show important reductions in HbA1c, weight and BMI in patients with type 2 diabetes mellitus after 3 months.  Recruitment and uptake of the intervention were successfully accomplished demonstrating feasibility to conduct larger effectiveness studies to test individual and mixed economic incentives for diabetes management. Registration: ClinicalTrials.gov Identifier NCT02891382

scholarly journals The effect of individual and mixed rewards on diabetes management: A feasibility randomized controlled trial

2018 ◽  
Vol 3 ◽  
pp. 139
Author(s):  
J. Jaime Miranda ◽  
María Lazo-Porras ◽  
Antonio Bernabe-Ortiz ◽  
M. Amalia Pesantes ◽  
Francisco Diez-Canseco ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Glycated Haemoglobin ◽  
Economic Incentives ◽  
Controlled Study ◽  
Randomized Controlled

Background: Incentives play a role in introducing health-related benefits, but no interventions using mixed incentives, i.e. a combination of individual and group incentives, have been tested in individuals with type 2 diabetes mellitus (T2DM). We evaluated the feasibility of implementing individual- and mixed-incentives, with and without a supportive partner, on glycated haemoglobin (HbA1c) control and weight loss among patients with T2DM. Methods: This is a feasibility, sex-stratified, single-blinded, randomized controlled study in individuals with T2DM. All participants received diabetes education and tailored goal setting for weight and glycated haemoglobin (HbA1c). Participants were randomly assigned into three arms: individual incentives (Arm 1), mixed incentives-altruism (Arm 2), and mixed incentives-cooperation (Arm 3). Participants were accompanied by a diabetes educator every other week to monitor targets, and the intervention period lasted 3 months. The primary outcome was the change in HbA1c at 3 months from baseline. Weight and change body mass index (BMI) were considered as secondary outcomes. Results: Out of 783 patients screened, a total of 54 participants, 18 per study arm, were enrolled and 44 (82%) completed the 3-month follow-up. Mean baseline HbA1c values were 8.5%, 7.9% and 8.2% in Arm 1, Arm 2, and Arm 3, respectively. At 3 months, participants in all three study arms showed reductions in HbA1c ranging from -0.9% in Arm 2 to -1.4% in Arm 1. Weight and BMI also showed reductions. Conclusions: Individual and mixed cash incentives show important reductions in HbA1c, weight and BMI in patients with type 2 diabetes mellitus after 3 months.  Recruitment and uptake of the intervention were successfully accomplished demonstrating feasibility to conduct larger effectiveness studies to test individual and mixed economic incentives for diabetes management. Registration: ClinicalTrials.gov Identifier NCT02891382

scholarly journals Efficacy and safety over 2 years of exenatide plus dapagliflozin in the DURATION-8 study: a multicenter, double-blind, phase 3, randomized controlled trial

2020 ◽  
Author(s):  
Serge A Jabbour ◽  
Juan P Frías ◽  
Azazuddin Ahmed ◽  
Elise Hardy ◽  
Jasmine Choi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Rescue Therapy ◽  
Controlled Trial ◽  
Glycated Haemoglobin ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
Exenatide Qw ◽  
Adjusted Least Squares

<b>OBJECTIVE: </b>In patients with type 2 diabetes uncontrolled with metformin, exenatide once weekly (QW) plus dapagliflozin produced greater reductions in glycemic parameters (glycated haemoglobin [HbA<sub>1c</sub>], fasting plasma glucose [FPG], and 2-hour postprandial glucose [2-h PPG]), weight, and systolic blood pressure (SBP) than exenatide QW or dapagliflozin alone after 28 weeks of treatment in DURATION-8. Following a 24‑week extension period, improvements were sustained at 52 weeks. Here, we investigated efficacy and safety at 104 weeks after randomization. <p><b>RESEARCH DESIGN AND METHODS:</b> DURATION-8 was a 104-week, multicenter, double-blind, randomized, active‑controlled, phase 3 trial. In total, 695 adults (age ≥18 years) with type 2 diabetes and inadequate glycemic control (HbA<sub>1c</sub>, 8.0%–12.0% [64–108 mmol/mol]) despite stable metformin monotherapy (≥1500 mg/day) were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo. All 104-week evaluations were exploratory. </p> <p><b>RESULTS: </b>At week 104, 431 (62.0%) patients completed treatment. The adjusted least squares mean (LSM) change [standard error] from baseline to week 104 in HbA<sub>1c </sub>was greater with exenatide QW plus dapagliflozin (–1.70% [0.11]) versus exenatide QW plus placebo (–1.29% [0.12]; <i>P</i>=0.007) and dapagliflozin plus placebo (–1.06% [0.12]; <i>P</i><0.001). Clinically relevant changes in FPG, 2-h PPG, weight and SBP were also observed with exenatide QW plus dapagliflozin. There were no unexpected safety findings and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia. </p> <p><b>CONCLUSIONS: </b>In this exploratory analysis, among those individuals who completed the trial without rescue therapy, there was clinically relevant efficacy over 2 years with exenatide QW plus dapagliflozin, with no unexpected safety findings.<b></b></p>

scholarly journals Culturally Tailored Self-Management Interventions for South Asians With Type 2 Diabetes: A Systematic Review

2019 ◽  
Vol 43 (6) ◽  
pp. 445-452 ◽  
Author(s):  
Nevin Navodia ◽  
Olive Wahoush ◽  
Tricia Tang ◽  
Jennifer Yost ◽  
Sarah Ibrahim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
South Asians ◽  
Self Management ◽  
Management Interventions ◽  
Culturally Tailored

scholarly journals Efficacy and safety over 2 years of exenatide plus dapagliflozin in the DURATION-8 study: a multicenter, double-blind, phase 3, randomized controlled trial

2020 ◽  
Author(s):  
Serge A Jabbour ◽  
Juan P Frías ◽  
Azazuddin Ahmed ◽  
Elise Hardy ◽  
Jasmine Choi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Rescue Therapy ◽  
Controlled Trial ◽  
Glycated Haemoglobin ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
Exenatide Qw ◽  
Adjusted Least Squares

<b>OBJECTIVE: </b>In patients with type 2 diabetes uncontrolled with metformin, exenatide once weekly (QW) plus dapagliflozin produced greater reductions in glycemic parameters (glycated haemoglobin [HbA<sub>1c</sub>], fasting plasma glucose [FPG], and 2-hour postprandial glucose [2-h PPG]), weight, and systolic blood pressure (SBP) than exenatide QW or dapagliflozin alone after 28 weeks of treatment in DURATION-8. Following a 24‑week extension period, improvements were sustained at 52 weeks. Here, we investigated efficacy and safety at 104 weeks after randomization. <p><b>RESEARCH DESIGN AND METHODS:</b> DURATION-8 was a 104-week, multicenter, double-blind, randomized, active‑controlled, phase 3 trial. In total, 695 adults (age ≥18 years) with type 2 diabetes and inadequate glycemic control (HbA<sub>1c</sub>, 8.0%–12.0% [64–108 mmol/mol]) despite stable metformin monotherapy (≥1500 mg/day) were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo. All 104-week evaluations were exploratory. </p> <p><b>RESULTS: </b>At week 104, 431 (62.0%) patients completed treatment. The adjusted least squares mean (LSM) change [standard error] from baseline to week 104 in HbA<sub>1c </sub>was greater with exenatide QW plus dapagliflozin (–1.70% [0.11]) versus exenatide QW plus placebo (–1.29% [0.12]; <i>P</i>=0.007) and dapagliflozin plus placebo (–1.06% [0.12]; <i>P</i><0.001). Clinically relevant changes in FPG, 2-h PPG, weight and SBP were also observed with exenatide QW plus dapagliflozin. There were no unexpected safety findings and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia. </p> <p><b>CONCLUSIONS: </b>In this exploratory analysis, among those individuals who completed the trial without rescue therapy, there was clinically relevant efficacy over 2 years with exenatide QW plus dapagliflozin, with no unexpected safety findings.<b></b></p>

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