scholarly journals The effect of a cluster-randomized controlled trial on lifestyle behaviors among families at risk for developing type 2 diabetes across Europe: the Feel4Diabetes-study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Vicky Van Stappen ◽  
Greet Cardon ◽  
Marieke De Craemer ◽  
Christina Mavrogianni ◽  
Nataliya Usheva ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
At Risk ◽  
Energy Balance ◽  
Vigorous Physical Activity ◽  
Intervention Group ◽  
Control Group ◽  
Lifestyle Behaviors ◽  
Intervention Effects

Abstract Background This study investigated the effect of the Feel4Diabetes-intervention, a 2-year multilevel intervention, on energy balance-related behaviors among European families at risk for developing type 2 diabetes. Intervention effects on self-reported physical activity, sedentary behavior and eating behaviors were investigated across and within the participating countries: Belgium, Finland, Greece, Spain, Hungary and Bulgaria. Methods Families were recruited through schools, located in low socio-economic status areas. In total, 4484 families at risk for developing type 2 diabetes were selected using the FINDRISC-questionnaire. Parents’ and children’s energy balance-related behaviors data were collected by questionnaires at three time points (baseline, mid- and post intervention). Families assigned to the intervention group were invited to participate in a 2-year school-, community-, and family-based intervention to promote a healthier lifestyle, including counseling sessions (first intervention year) and text messages (second intervention year). Families assigned to the control group received standard care, including medical check-up results and recommendations and tips regarding a healthy lifestyle. To assess the intervention-effects, Mixed Models were conducted using the R-Package “lmer “with R v3.2. Results Significant intervention effects were found on a certain number of families’ lifestyle behaviors. Significant favorable intervention effects were detected on parents’ water consumption and consumption of fruit and vegetables, and on children’s consumption of sweets and moderate-to-vigorous physical activity. Analyses by country revealed significant favorable intervention effects on water consumption and on moderate-to-vigorous physical activity in Belgian parents and on fruit and vegetable consumption among Belgian children, on sweets consumption among Spanish parents and children, and on moderate-to-vigorous physical activity among Finnish children. Unfavorable intervention effects were found on the consumption of soft drinks and sugar-containing juices among Hungarian children and parents, while when examining the intervention effects for the overall population and per country, 10 from the 112 investigated outcome variables were improved in the intervention group compared to the control group (9%). Conclusions The Feel4Diabetes-intervention managed to improve a certain number of targeted lifestyle behaviors while the intervention was not effective on a large number of targeted lifestyle behaviors. The findings of the current study are encouraging, but further research is needed on how we can further improve effectiveness of lifestyle interventions to prevent type 2 diabetes in families at risk. Trial registration The Feel4Diabetes-study is registered with the clinical trials registry http://clinicaltrials.gov, ID: 643708.

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

scholarly journals Moderate-Vigorous Physical Activity and Clinical Parameters in Adults with Type 2 Diabetes Mellitus: A Report from the Walking with Diabetes Study

2019 ◽  
Vol 26 (2) ◽  
pp. 107-117
Author(s):  
Novita Intan Arovah ◽  
Bernadeta Maria Wara Kushartanti
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Vigorous Physical Activity ◽  
Control Group ◽  
Clinical Parameters ◽  
Protective Effects ◽  
Activity Data

Abstract Background and aims: This study investigate the effects of increases in moderate-vigorous physical activity (MVPA) on several clinical parameters in Indonesian type 2 diabetes mellitus (T2DM) patients. Material and methods: This study used clinical and physical activity data of forty-two T2DM patients who completed a 6 month-free-living physical activity program, the Walking with Diabetes Study. Upon completion of the program, participants were categorised into a group with increases in MVPA (the MVPA+ group, n=24) or a group with steady/decreases in MVPA (the control group, n=18). High density lipoprotein, triglyceride, routine hematology profiles, blood pressure, body mass index, weight/hip ratio and self-reported MVPA, at baseline, 3 and 6 months were retrospectively analysed. Generalized estimating equation adjusted for age and sex were conducted to assess group and time effects on the clinical parameters. Results: Hemoglobin (p <0.01), erythrocytes (p<0.05), hematocrits (p<0.001) and thrombocytes (p<0.05) were higher in the MVPA+ group. The 1h and 2h-erythrocyte sedimentation rate (ESR) increased in both groups across time (p<0.001). No changes between groups across time were found for other parameters. Conclusions: Increases in MVPA improve several hematology parameters in T2DM patients, but it does not have protective effects in controlling systemic inflammation in T2DM patients.

Effect of a multifactorial intervention on the increase in physical activity in subjects with type 2 diabetes mellitus: a randomized clinical trial (EMID Study)

2019 ◽  
Vol 18 (5) ◽  
pp. 399-409 ◽  
Author(s):  
Rosario Alonso-Domínguez ◽  
María C Patino-Alonso ◽  
Natalia Sánchez-Aguadero ◽  
Luis García-Ortiz ◽  
Jose I Recio-Rodríguez ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Type 2 Diabetes Mellitus ◽  
Intervention Group ◽  
Control Group ◽  
Multifactorial Intervention ◽  
Metabolic Equivalent

Background: Regular physical activity is essential for metabolic control in type 2 diabetes mellitus. Aims: The aim of this study was to assess the short and long-term impact of a multifactorial intervention on physical activity and clinically relevant biochemical parameters in patients with type 2 diabetes mellitus. Methods: This randomised, controlled clinical trial (NCT02991079) included two parallel groups aged 25–70 years from a primary care health centre in Salamanca, Spain. The subjects were assigned randomly (1:1) to control and intervention groups, using Epidat 4.0 software. Both were counselled on the importance of physical activity and maintaining a healthy diet. The intervention group also took five low–moderate intensity 4 km nurse-guided walks, received a smartphone application to promote healthy habits and attended a diet workshop. Physical activity was measured objectively using a pedometer and subjectively using a shortened international physical activity questionnaire (at baseline, 3 and 12 months). Results: In total, 204 subjects were included (mean age 60.6 years, 45.6% were women). After 3 months, relative to the control group, the intervention group increased their daily number of steps by 1852, aerobic steps by 1623, distance walked by 994 m, and total metabolic equivalent minutes per week by 1297 and decreased sedentary time by 34.3 minutes per day. Differences from baseline persisted at 12 months, including mean increases of 1141 daily steps, 917 aerobic steps, and 1065 total metabolic equivalent minutes per week in the intervention group relative to the control group ( P<0.05 for all). Conclusions: The success of this multifactorial intervention should help inform future clinical approaches and application designs towards managing type 2 diabetes mellitus and improving patient outcomes.

scholarly journals Effectiveness of a Behavior Change Technique–Based Smartphone Game to Improve Intrinsic Motivation and Physical Activity Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Christoph Höchsmann ◽  
Denis Infanger ◽  
Christopher Klenk ◽  
Karsten Königstein ◽  
Steffen P Walz ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Behavior Change ◽  
Intrinsic Motivation ◽  
Intervention Group ◽  
Control Group ◽  
Intervention Period ◽  
Behavior Change Technique

BACKGROUND Regular physical activity (PA) is an essential component of a successful type 2 diabetes treatment. However, despite the manifest evidence for the numerous health benefits of regular PA, most patients with type 2 diabetes remain inactive, often due to low motivation and lack of PA enjoyment. A recent and promising approach to help overcome these PA barriers and motivate inactive individuals to change their PA behavior is PA-promoting smartphone games. While short-term results of these games are encouraging, the long-term success in effectively changing PA behavior has to date not been confirmed. It is possible that an insufficient incorporation of motivational elements or flaws in gameplay and storyline in these games affect the long-term motivation to play and thereby prevent sustained changes in PA behavior. We aimed to address these design challenges by developing a PA-promoting smartphone game that incorporates established behavior change techniques and specifically targets inactive type 2 diabetes patients. OBJECTIVE To investigate if a self-developed, behavior change technique-based smartphone game designed by an interdisciplinary team is able to motivate inactive individuals with type 2 diabetes for regular use and thereby increase their intrinsic PA motivation. METHODS Thirty-six inactive, overweight type 2 diabetes patients (45-70 years of age) were randomly assigned to either the intervention group or the control group (one-time lifestyle counseling). Participants were instructed to play the smartphone game or to implement the recommendations from the lifestyle counseling autonomously during the 24-week intervention period. Intrinsic PA motivation was assessed with an abridged 12-item version of the Intrinsic Motivation Inventory (IMI) before and after the intervention. In addition, adherence to the game-proposed PA recommendations during the intervention period was assessed in the intervention group via the phone-recorded game usage data. RESULTS Intrinsic PA motivation (IMI total score) increased significantly in the intervention group (+6.4 (SD 4.2; P<.001) points) while it decreased by 1.9 (SD 16.5; P=.623) points in the control group. The adjusted difference between both groups was 8.1 (95% CI 0.9, 15.4; P=.029) points. The subscales “interest/enjoyment” (+2.0 (SD 1.9) points, P<.001) and “perceived competence” (+2.4 (SD 2.4) points, P<.001) likewise increased significantly in the intervention group while they did not change significantly in the control group. The usage data revealed that participants in the intervention group used the game for an average of 131.1 (SD 48.7) minutes of in-game walking and for an average of 15.3 (SD 24.6) minutes of strength training per week. We found a significant positive association between total in-game training (min) and change in IMI total score (beta=0.0028; 95% CI 0.0007-0.0049; P=.01). CONCLUSIONS In inactive individuals with type 2 diabetes, a novel smartphone game incorporating established motivational elements and personalized PA recommendations elicits significant increases in intrinsic PA motivation that are accompanied by de-facto improvements in PA adherence over 24 weeks. CLINICALTRIAL ClinicalTrials.gov NCT02657018; https://clinicaltrials.gov/ct2/show/NCT02657018

scholarly journals Early Lifestyle Interventions in People with Impaired Glucose Tolerance in Northern Colombia: The DEMOJUAN Project.

2019 ◽  
Vol 16 (8) ◽  
pp. 1403
Author(s):  
Barengo ◽  
Acosta ◽  
Arrieta ◽  
Ricaurte ◽  
Smits ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutritional Intervention ◽  
Control Group ◽  
Lifestyle Interventions ◽  
Relative Risks

Background: The objective of the demonstration project for type 2 diabetes prevention in the Barranquilla and Juan Mina (DEMOJUAN) study was to investigate the extent to which it is possible to reach normal glucose metabolism with early lifestyle interventions in people at high risk of type 2 diabetes (prediabetes), compared with those who receive standard usual care. Methods: DEMOJUAN was a randomized controlled trial conducted in Juan Mina and Barranquilla, Northern Colombia. Eligible participants were randomized into one of three groups (control group, initial nutritional intervention, and initial physical activity intervention). The duration of the intervention was 24 months. The main study outcome in the present analysis was reversion to normoglycemia. Relative risks and their corresponding 95% confidence intervals were calculated for reversal to normoglycemia and T2D incidence. Results: There was no statistically significant association between the intervention groups and reversion to normoglycemia. The relative risk of reversion to normoglycemia was 0.88 (95% CI 0.70–1.12) for the initial nutritional intervention group participants and 0.95 (95% CI 0.75–1.20) for the initial physical activity intervention group participants. Conclusions: Our study did not find any statistically significant differences in reversion to normoglycemia or the development of type 2 diabetes between the intervention groups and the control group in this population.

scholarly journals Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care—results of the cluster-randomised controlled DEBATE trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anja Wollny ◽  
Christin Löffler ◽  
Eva Drewelow ◽  
Attila Altiner ◽  
Christian Helbig ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Decision Making ◽  
Type 2 Diabetes Mellitus ◽  
Shared Decision Making ◽  
Intervention Group ◽  
Control Group ◽  
Shared Decision ◽  
Patient Centeredness

Abstract Background We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. Conclusions The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. Trial registration The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571.

scholarly journals Rationale and design of a type 2 diabetes prevention intervention for at-risk mothers and children at a Federally Qualified Healthcare Center: EPIC El Rio Families Study Protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David G. Marrero ◽  
Robert M. Blew ◽  
Kelly N. B. Palmer ◽  
Kyla James ◽  
Denise J. Roe ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
At Risk ◽  
Cardiovascular Health ◽  
Excess Body Weight ◽  
Lifestyle Behaviors ◽  
Increased Risk ◽  
Group Randomized Trial ◽  
Prevention Model ◽  
History Of

Abstract Background Exposure to gestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes (T2DM) in mothers, and poor cardiovascular health among offspring. Identifying effective methods to mitigate T2DM risk has the potential to improve health outcomes for mothers with a history of GDM and their children. The goal of the EPIC El Rio Families Study is to implement and evaluate the effects of a 13-week behavioral lifestyle intervention on T2DM risk factors in at-risk mothers and their 8- to 12-year-old children. We describe herein the rationale for our specific approach, the adaption of the DPP-based curriculum for delivery to patients of a Federally Qualified Health Center (FQHC), and the study design and methodology. Methods The effects of the intervention on reduction in excess body weight (primary outcome), hemoglobin A1c, blood pressure, and changes in lifestyle behaviors associated with weight trajectory and T2DM risk in mother-child dyads will be evaluated during a 13-week, group randomized trial wherein 60 mothers and their children will be recruited to the intervention or wait-listed control conditions at one of two FQHC locations. Intervention participants (n = 30) will begin the group program immediately, whereas the wait-listed controls (n = 30) will receive a booklet describing self-guided strategies for behavior change. Associated program delivery costs, acceptability of the program to participants and FQHC staff, and potential for long-term sustainability will also be evaluated. Discussion Successful completion in our aims will produce a scalable program with high potential for replication and dissemination, and estimated intervention effects to inform T2DM prevention efforts on families who use the FQHC system. The results from this study will be critical in developing a T2DM prevention model that can be implemented and scaled across FQHCs serving populations disproportionately burdened by T2DM. Trial registration ClinicalTrials.gov NCT03781102; Date of registration: 19 December 2018.

Abstract P112: Changes in Lifestyle Behavior to Reduce Uncontrolled Blood Pressure in the Faith Trial

Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Kristie J Lancaster ◽  
Antoinette M Schoenthaler ◽  
William Chaplin ◽  
Gbenga Ogedegbe
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Medication Adherence ◽  
Lifestyle Modification ◽  
Intervention Group ◽  
Black Americans ◽  
Control Group ◽  
Lifestyle Behaviors ◽  
Uncontrolled Blood Pressure ◽  
Faith Based

Introduction: Modifying lifestyle behaviors is a key method for controlling hypertension. This strategy is extremely important for hypertensive Black Americans, as they are more likely to have uncontrolled blood pressure (BP), have a higher risk of complications, and poorer outcomes. To address this need, we conducted a cluster-randomized controlled trial to reduce BP through lifestyle modification that was delivered by lay health advisors in Black churches. The Faith-based Approaches in the Treatment of Hypertension (FAITH) trial was designed to evaluate the effectiveness of a 12-week faith-based lifestyle intervention and subsequent 3-month motivational interviewing vs. health education control on BP reduction among hypertensive Black adults. This study examines the change in lifestyle behaviors during the trial from baseline to 6 months. Methods: We recruited 373 Black Americans with uncontrolled hypertension from 32 urban churches. BP was considered to be uncontrolled if systolic BP (SBP)≥140 mmHg or diastolic BP (DBP)≥90 mmHg, or DBP≥130 mmHg or DBP≥80 mmHg for participants with self-reported diabetes or kidney disease The primary outcome was within-participant change in BP from baseline to 6 months. Lifestyle data collected included the NCI fruit/vegetable intake screener and % calories from fat screener, the International Physical Activity Questionnaire (IPAQ), medication adherence, and measured height and weight. Results: Participants’ mean age was 63.4 y, 76.4% were female, and 96.1% reported being of African descent. The mean BMI was 32.1 kg/m2. At 6 months, the intervention was associated with significant reduction in SBP but not DBP compared with the control group (-16.0 mmHg vs -10.3 mmHg, p=0.017). There was no significant change in number of servings of fruits and vegetables consumed, minutes walked per day, or weight for either group. However, the intervention group had a slight but significantly greater decrease of 1.08 % calories from fat over time compared with the control (p=0.018), but that change was not related to change in SBP. Most notably, there was a significant months x treatment interaction on medication adherence the intervention group had a greater decrease in non-adherence score than the control (-0.84 vs -0.30, p=0.28). This improvement in adherence was related to decrease in SBP (p=0.019). Conclusion: Community-based lifestyle modification program led to significantly reduced systolic BP; and this intervention effect was mediated by improved medication adherence. However, the 12-week intervention resulted in little change in key diet and physical activity behaviors found in other trials to positively affect BP.

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