Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial.
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SUBMITTER: Voils CI
PROVIDER: S-EPMC3464684 | biostudies-literature | 2012 Aug
REPOSITORIES: biostudies-literature
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Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial.
Voils Corrine I CI Coffman Cynthia J CJ Edelman David D Maciejewski Matthew L ML Grubber Janet M JM Sadeghpour Azita A Cho Alex A McKenzie Jamiyla J Blanpain Francoise F Scheuner Maren M Sandelowski Margarete M Gallagher M Patrick MP Ginsburg Geoffrey S GS Yancy William S WS
Trials 20120801
<h4>Background</h4>We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes.<h4>Methods/design</h4>Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m(2) and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genet ...[more]
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Project description:ObjectiveWe examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling.Research design and methodsIn this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM.ResultsThe mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: -0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: -0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p's ≤ 0.05) but not at 6 months (p's > 0.20).ConclusionsProviding patients with genetic test results was not more effective in changing patient behavior to reduce the risk of DM compared to conventional risk counseling.Trial registrationClinicalTrials.gov NCT01060540 http://clinicaltrials.gov/show/NCT01060540.
| S-EPMC4617940 | biostudies-literature
Project description:Rapid advances in diabetes genetic epidemiology may lead to a new era of "personalized medicine" based on individual genetic risk assessment. There is minimal experience to guide how best to clinically implement such testing so that results (e.g., "higher" or "lower" relative genetic risk) improve rather than reduce patient motivation for behavior change.Between November 2009 and May 2010, we conducted in-depth interviews with 22 overweight participants at high phenotypic risk for type 2 diabetes to explore perceptions of diabetes genetic risk testing compared with currently available prediction using nongenetic risk factors (e.g., family history, abnormal fasting glucose, obesity). We used hypothetical scenarios to specifically investigate the impact of both "higher" and "lower" relative genetic risk results on participants' views about diabetes prevention.Many participants conferred a unique value on personal genetic risk information relative to nongenetic risk based on the perceived scientific certainty and durability of genetic results. In contrast, other participants considered their genetic risk within the overall context of their other measured risk factors. Reactions to diabetes genetic test results differed by current motivation levels. Whereas most subjects reported that "higher" risk results would motivate behavior change, subjects with lower current motivation often reported that "lower" genetic risk results would further reduce their motivation to engage in diabetes prevention behaviors.To be effective, future clinical implementation of type 2 diabetes genetic risk testing should be individualized based on each patient's risk perception and current level of motivation to prevent diabetes.
| S-EPMC3041182 | biostudies-literature
Project description:BackgroundThe nonpharmacological approach to diabetic control in patients with diabetes focuses on a healthy diet, physical activity, and self-management. Therefore, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns and include brief advice and counseling services. Within this context, motivational interviewing (MI) has proven to be effective in changing health behaviors for specific cases. However, stronger evidence is needed on the effectiveness of MI in treating chronic pathologies such as diabetes.ObjectiveThis study will obtain preliminary data on the impact of a nurse-led MI intervention in improving glycemic control, as well as clinical, psychosocial, and self-care outcomes for individuals with type 2 diabetes mellitus when compared with usual care, with the aim of improving diabetic control in patients with diabetes.MethodsAn open, two-arm, parallel, randomized controlled, pilot exploratory trial will be performed. Two government outpatient clinics in the New Territories West Cluster in Hong Kong will be involved. In total, 20 to 25 participants will be invited in each arm. Intervention participants will receive face-to-face MI interventions in addition to their usual care from the clinic. Control participants will only receive usual care. Outcomes are assessed at baseline, 6 months, and 12 months. The primary outcome measure is glycated hemoglobin levels. Secondary outcomes include blood pressure, BMI, hip and waist circumference, fasting blood, and psychosocial and self-care measures.ResultsThis study is currently underway with funding support from the Hong Kong College of Family Physician Research Seed Fund 2017.ConclusionsMI skills constitute the main strategies primary care nurses use on their patients. Having economical, simple, effective, and applicable techniques is essential for primary care professionals to help their patients change their lifestyle and improve their health. This study will provide scientific evidence on the effectiveness of MI. It will be performed with strict control over the data collection, ensuring the maintenance of therapeutic integrity.Trial registrationCentre for Clinical Research and Biostatistics CUHK_CCRB00614; https://tinyurl.com/v9awzk6.International registered report identifier (irrid)DERR1-10.2196/15709.
| S-EPMC7157490 | biostudies-literature
Project description:BACKGROUND: The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16. DISCUSSION: The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus. TRIAL REGISTRATION: Sri Lanka Clinical Trial Registry: SLCTR/2012/010.
| S-EPMC3599871 | biostudies-other
Project description:Many informal caregivers of persons with dementia suffer adverse health consequences. Although established psychoeducation programs are known to benefit caregivers, attending in-person programs is challenging for them. To address this challenge, the Savvy Caregiver Program, an evidence-based psychoeducation program with demonstrated effectiveness for caregiving and disease-related outcomes, was transformed into an on-line program, Tele-Savvy. This article describes the rationale for and design of a prospective longitudinal randomized controlled trial (targeted N?=?215), currently underway. The trial aims to establish Tele-Savvy's efficacy in (i) reducing the negative effects of caregiving on caregivers; (ii) promoting care recipients' quality of life; (iii) improving caregiver mastery; and to explore (iv) Tele-Savvy's efficacy among caregivers of different races/ethnicities. The mediating role of mastery will be assessed. Participants are randomized to the active condition (immediate Tele-Savvy participation), attention control, or usual care. Participants in the two latter conditions will complete Tele-Savvy 6 months post-baseline. Multilevel mixed effects models will be used to examine changes in outcomes and to model group by time (months since baseline) interactions. The exploratory aim will be addressed using analysis of covariance and qualitative analysis. This trial's results may be used by healthcare and community organizations to implement Tele-Savvy in dementia care, increasing caregivers' access to this evidence-based intervention.
| S-EPMC5945279 | biostudies-literature
Project description:BackgroundPreschoolers regularly display disruptive behaviors in child care settings because they have not yet developed the social skills necessary to interact prosocially with others. Disruptive behaviors interfere with daily routines and can lead to conflict with peers and educators. We investigated the impact of a social skills training program led by childcare educators on children's social behaviors and tested whether the impact varied according to the child's sex and family socio-economic status.MethodsNineteen public Child Care Centers (CCC, n = 361 children) located in low socio-economic neighborhoods of Montreal, Canada, were randomized into one of two conditions: 1) intervention (n = 10 CCC; 185 children) or 2) wait list control (n = 9 CCC; 176 children). Educators rated children's behaviors (i.e., disruptive and prosocial behaviors) before and after the intervention. Hierarchical linear mixed models were used to account for the nested structure of the data.ResultsAt pre-intervention, no differences in disruptive and prosocial behaviors were observed between the experimental conditions. At post-intervention, we found a significant sex by intervention interaction (β intervention by sex = - 1.19, p = 0.04) indicating that girls in the intervention condition exhibited lower levels of disruptive behaviors compared to girls in the control condition (f2 effect size = - 0.15). There was no effect of the intervention for boys.ConclusionsGirls may benefit more than boys from social skills training offered in the child care context. Studies with larger sample sizes and greater intervention intensity are needed to confirm the results.Trial registrationCurrent clinical trial number is ISRCTN84339956 (Retrospectively registered in March 2017). No amendment to initial protocol.
| S-EPMC7181512 | biostudies-literature
Project description:BackgroundChronic diseases are a substantial public health issue worldwide and affect an individual's quality of life. Due to the alarming rise in type 2 diabetes, health care that was primarily focused on diagnosis and treatment of the disease is increasingly focused on prevention and self-care. Patients who adhere to a constant and strict treatment regimen (physical activity, diet, medication) and regularly monitor their health are more likely to maintain self-care and health, prevent the exacerbation of the disease, and avoid the complications of diabetes (retinopathy, diabetic feet, etc). In recent years, many innovative devices that have become increasingly present in inpatient health care, such as mobile apps, are available to help patients maintain consistency in monitoring their health status. Mobile apps make it easier for individuals to monitor their self-care and illness and follow instructions regarding disease control.ObjectiveThis study aims to determine the impact of mobile app use on self-care in patients with type 2 diabetes. We will evaluate and test the usefulness of the forDiabetes app as a tool to improve the self-care of individuals with type 2 diabetes.MethodsWe will perform a double-blind randomized controlled trial. The study will include individuals aged over 18 years diagnosed with or have regulated type 2 diabetes who are treated in family medicine practices. Additionally, the individuals included in the study should not have any acute complications due to the consequences of type 2 diabetes. They will use an Android or iOS mobile phone and a blood glucose meter during the investigation. With the help of simple randomization, individuals will be divided into the intervention and control groups. Individuals in the intervention group will use the forDiabetes mobile app to monitor their self-care for type 2 diabetes. Individuals in the control group will not receive a particular intervention. Data will be collected using the Self-care of Diabetes Inventory questionnaire and Brief Illness Perception Questionnaire. Blood sugar, blood pressure, glycated hemoglobin (HbA1c), and weight measurements will be monitored using calibrated instruments during the study by the nurses employed at the family medicine practice. Data will be collected at the beginning of the study and after a patient visits the family medicine practice.ResultsIn the first half of 2020, we have prepared a translation of the mobile app that will be used by the participants of the intervention group, as well as more detailed instructions for using the app. We have also prepared a translation of the questionnaires in Slovene. The research results will be published in 2023.ConclusionsThis research contributes to greater visibility and usability of mobile apps for the self-care of patients with type 2 diabetes and raises awareness of the possible use of innovative methods.Trial registrationClinicaltrials.gov NCT04999189; https://clinicaltrials.gov/ct2/show/NCT04999189.International registered report identifier (irrid)PRR1-10.2196/31652.
| S-EPMC9250066 | biostudies-literature
Project description:The early identification of individuals at risk for type 2 diabetes (T2D) enables prevention. Recent genome-wide association studies (GWAS) have added at least 40 genetic variants to the list of already well characterized T2D risk predictors, including family history, obesity, and elevated fasting plasma glucose levels. Although these variants can significantly predict T2D alone and as a part of genotype risk scores, they do not yet offer clinical discrimination beyond that achieved with common clinical measurements. Future progress on at least two research fronts may improve the predictive performance of genotype information. First, expanded GWAS efforts in non-European populations will allow targeted sequencing of risk loci and the identification of true causal variants. Second, studies with longer prediction time horizons may demonstrate that genotype information performs better than clinical risk predictors over a longer period of the life course. At present, however, genetic testing cannot be recommended for clinical T2D risk prediction in adults.
| S-EPMC4070012 | biostudies-literature
Project description:BackgroundThis study aimed to assess the effects of digital storytelling on the self-management behavior of adolescents with type 1 diabetes (TID).MethodsIn this pilot randomized controlled clinical trial, 60 adolescents with TID were randomly allocated into two parallel groups: intervention (training with digital storytelling method, n = 33) or control (training with a conventional method, n = 33). The primary outcome was assessing the Self-Management behavior of adolescents with TID (SMOD-A) at baseline and three months after the intervention.ResultsThe results revealed that digital storytelling could significantly improve self-management behaviors amongst adolescents with TID (P = 0.005). In contrast, in the control group, no significant changes were observed (P > 0.05). Furthermore, the mean score of Collaboration with Parents subscale was significantly higher in the digital storytelling group than in the control group after the intervention (p = 0.022). The results also showed that the level of Collaboration With Parents' subscale scores had a meaningful reverse relationship with the adolescent age after digital storytelling (p = 0.048). Repeated measures ANOVAs showed that there were significant main effects of time and group on collaboration with parents(p = 0.002) and goal subscales (p = 0.035). With respect to HbA1c levels, significant changes were not observed in any of the groups (P > 0.05).ConclusionsDigital storytelling is practicable and a potentially beneficial training modality for adolescents with TID.Trial registrationThis trial was respectively registered.Clinicaltrialsgov Identifier: IRCT20191220045828N1 . Date of registration: Oct 29. 2020.
| S-EPMC8941790 | biostudies-literature
Project description:BackgroundAdolescents living with type 1 diabetes (T1D) often experience diabetes distress (DD), a construct distinct from depression or anxiety that refers to the negative emotions that arise from living with and managing diabetes. Self-compassion, which involves being open to one's own suffering and treating oneself with the same care one would show to loved ones, is associated with better psychological and clinical outcomes among individuals with T1D. Self-compassion is a skill that can be taught and therefore represents an opportunity for intervention.ObjectiveThe overall aim of this study is to assess the effectiveness of a web-based mindful self-compassion for teens (MSC-T) intervention on improving DD, anxiety, depression, diabetes-related disordered eating, and suicidal ideation experienced by youth with T1D (aged between 12 and 17 years) compared with a waitlist control group (standard of care). We will also explore (1) if the effect of the MSC-T intervention changes over time, (2) if the MSC-T intervention has a positive impact on measures of glycemic control, and (3) if the effect of the MSC-T intervention differs based on self-reported gender.MethodsWe will conduct a single-center, parallel-group randomized controlled trial of 140 adolescents with T1D followed for 12 months. Participants will be randomly allocated (using hidden allocation) in a 1:1 ratio to either the MSC-T intervention or the waitlist control group. Our primary outcome is DD, as measured by the Problem Areas in Diabetes-Teen (PAID-T) version at 3 months. Secondary outcomes, assessed at 3 and 12 months, include anxiety (Generalized Anxiety Disorder 7-item [GAD-7] scale), depression (Patient Health Questionnaire-9 [PHQ-9]), diabetes-related disordered eating (Diabetes Eating Problem Survey-Revised [DEPS-R] version), and suicidal ideation (using 1 question from the PHQ-9).ResultsStudy recruitment began in October 2022 and was completed in March 2023, with a total of 141 participants enrolling. Data collection will be ongoing until March 2024. The first results are expected in June 2024.ConclusionsThis study will be the first randomized trial to assess the effectiveness of the web-based MSC-T intervention on adolescents with T1D. Given that adolescence is a period where individuals are typically required to assume more responsibility for their diabetes care, providing adolescents with the tools they need to better manage the stress that often accompanies T1D management is paramount.Trial registrationClinicalTrials.gov NCT05463874; https://clinicaltrials.gov/study/NCT05463874.International registered report identifier (irrid)DERR1-10.2196/53935.
| S-EPMC10777281 | biostudies-literature