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Diabetes prevention is a public health priority that is dependent upon the reach, effectiveness, and cost of intervention strategies. However, understanding each of these outcomes within the context of randomized controlled trials is problematic. This study uses a unique hybrid design that allows an assessment of reach by providing participants choice between interventions and an assessment of effectiveness and cost using a standard randomized controlled trial RCT. The trial, which was developed using the RE-AIM framework, will contrast the effects of 3 interventions:

1. Introduction

Innovatir prevention is a public health priority that is dependent upon the reach, effectiveness, and cost of intervention strategies. However, understanding each of these outcomes within the context of randomized controlled trials is problematic. This study uses a unique hybrid design that allows an assessment Erfolgsstories bei unseren Speed Datings. reach by providing participants choice between interventions and an assessment of effectiveness and cost using a standard randomized controlled trial RCT.

The trial, which was developed using the RE-AIM framework, will contrast the effects of 3 interventions: Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the Diabetes Prevention Program DPP. Adult patients at risk for diabetes Dmo be randomly assigned to either choice or RCT.

This will be the first diabetes prevention trial that will allow the research team to determine the relationships between reach, effectiveness, and cost of different interventions. The prevention of Type 2 diabetes is a public health priority due to its prevalence, negative influence Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes) health, and lack of a known cure [ 1 ].

The results of the Diabetes Prevention Program DPP indicated that modest weight loss achieved through diet and exercise was effective in delaying the onset of Type 2 diabetes [ 2 ]. Given the potential public health impact of DPP a number of efforts have been made to translate the lifestyle intervention into practice. A recent review reported on 28 effectiveness trials based on the DPP lifestyle intervention or its principals [ 3 ].

On average, across healthcare or community setting and whether delivered by health professionals, lay leaders, or interactive technology, these interventions were able to facilitate a similar percent reduction in body weight as the original DPP [ 3 ].

While the findings from these trials are promising and certainly speak towards the potential for diabetes prevention activities to be effective in community and clinical practice, there is a paucity of information on other key factors necessary to determine if these interventions can truly be translated into practice [ 4 ]. Specifically, Glasgow and colleagues suggested that when planning and evaluating lifestyle interventions, the translation of research evidence into practice will be better informed by assessing information across a number of outcomes represented by the RE-AIM framework [ 5 ].

This includes reporting on r each, Innovtor ffectiveness, and m aintenance of effects at the individual level and a doption, i mplementation and m aintained delivery at the organizational level. Similarly, Abrams and colleagues proposed that to understand the overall impact of evidence-based strategies, two factors are critical to the overall impact on the target population—reach and effectiveness [ 6 ]. Specifically, if an effective intervention cannot reach a significant and representative proportion of the target population it will have limited impact.

The evidence that key elements of the DPP lifestyle intervention can be successfully applied in multiple community and clinical settings is extremely promising, but to date there is a lack of literature related to the reach of diabetes prevention strategies beyond simply reporting on the number of participants or a participation rate based on an inconsistent denominator [ 4 ]. In fact, the calculation of actual reach is never possible within the traditional RCT designs where participants must consent to being randomized to one of the available conditions.

As such, innovative designs that allow Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes) to investigate both reach and effectiveness of diabetes prevention programs are needed. Applications of the RE-AIM framework also recommend understanding the costs of intervention delivery rating terms of reach and effectiveness [ 7 ].

To date, determining the cost-effectiveness of diabetes prevention has been tied solely to information gleaned from the outcomes of the DPP trial [ 8 — 11 ]. In nearly every case, Innovvator diabetes prevention trials in the United States were adapted to reflect the DPP key elements using a lower frequency of sessions e.

These adaptations are made as a method to reduce intervention costs, but only three studies reported cost explicitly and those that do have simply reported on the cost of the intervention rather than on AAras in achieving outcomes [ 131821 ]. Studies that determine the relationships between reach, effectiveness and cost of diabetes prevention programs delivered in typical clinical or community settings are needed.

Based on this five-fold focus we developed two potentially scalable interventions that could, after appropriate testing, be broadly adopted, easily implemented, and sustained in typical healthcare sies. Both interventions are 12 months in duration and include a live call to assist participants in initiating changes and 22 interactive nInovator response IVR follow-up support calls.

The primary purposes of the project are to determine the reach of each active intervention i. Secondary purposes Dating sites review australia A Brief Look at: Aras Innovator Impact Matrix (4 Minutes) reporting on the adoption rate of family and community medicine clinics and physicians approached to participate and the degree to which the interventions are delivered as intended, as well as determining whether participant preference impacts intervention effectiveness when compared to a control group.

Patients at risk for developing diabetes will be randomly assigned to either a Choice group or a Randomization group. This design maximizes efficiency in testing of new interventions by capitalizing on the strengths of both the RCT and preference designs [ 25 — 27 ].

This study and protocol were approved by the Carilion Clinic Institutional Review Board and is registered at clinicaltrials. Carilion Clinic serves 18 counties and six cities in Western and Southwestern Virginia and employs nearly physicians across practices. Patients who receive care at the Carilion Clinic Family and Community Medicine Clinics in the greater Roanoke Metropolitan area in southwest Virginia will be invited to participate in this study.

The inclusion and exclusion criteria see table 1 for detailed information are as broad as possible to improve the likelihood of attracting a representative sample of patients at risk for type 2 diabetes to the study and increase the likelihood that our findings are generalizable and relevant to typical patient populations [ 22 — 24 ].

Initial eligibility will be determined using Carilion Clinic electronic medical records to identify potential participants i. Finally, all participants will be screened for information necessary to complete the Diabetes Risk Calculator [ 28 ] to ensure patients at risk for diabetes are enrolled in the study. The Diabetes Risk Calculator uses 7 items to evaluate diabetes risk including questions related to age, sex, gestational diabetes, family history with diabetes, blood pressure levels, physical activity levels, and current weight and height.

Individuals with a score of 5 or higher are considered to be in particularly greater risk and will be the target for recruitment into the current project. Additionally, those who are positively identified as having diabetes will be excluded from the study.

To date, all Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes) have agreed to take part in the study with 2 clinics being selected to initiate participation based on the population served primarily low income or racial minority Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes).

After initial patient identification, Carilion Clinic physicians will have Mqnagement opportunity to review the list of their patients who have been identified as potentially eligible for Serids study at each data pull. These physicians will be able to request the removal of any patient from the recruitment process.

Physicians not willing to participate in the study will have their patients removed from the potential participant list. Patients assigned to the Randomization group will Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes) a similar letter that describes the RCT. All patients who do not return the opt-out postcard will receive an outreach recruitment call. During this call, a research assistant will reiterate the key points of the letter, answer any questions, determine initial eligibility, assess whether patient wishes to participate, and if so, obtain full contact information and schedule a baseline study visit.

Msnagement with disconnected numbers or no telephone number on file will be excluded from the trial, but will be included in the documentation of the proportional reach of the study. Informed consent procedures and baseline assessments will be completed at the time of the first study visit.

Once all baseline assessments are completed participants will either be randomized to one of the RCT groups or given the opportunity to choose which program they would like to take part in.

A DVD player will be provided at no cost to those participants without one. We used weight change as the primary outcome variable and, based on our previous studies [ 29 — 31 ], we projected an average weight loss of 5. To determine the potential of weight regain to influence the power of the study Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes) projected the potential weight loss maintenance at both 12 and 18 months using averages from two studies that include similar intervention strategies to maintain weight loss [ 3233 ] i.

Thus at 12 months we projected 4. Using these differences in weight and standard deviations while assuming a correlation of. Carilion Clinic currently offers a 2-hour small group session that was designed to help patients develop a personal action plan for diabetes prevention [ Innovxtor — 31 ].

Details of the content of this intervention have been fully described elsewhere [ 29 — 31 ]. A program outline and content were developed to facilitate discussion among the participants, prompting group conversation, allowing exchange of ideas around social cues for living a healthy lifestyle, ways to eat healthfully when dining out, the use of stimulus controls, and ways Canada online dating website UPCOMING WEBINARS get back on track when sittes slips out of a healthy routine [ 29 Goof, 30 ].

Instructors also provide a workbook covering all 22 session topics table 2 and self-monitoring tools to be used throughout the program designed to track weight loss, physical activity, and dietary behaviors.

This intervention was developed to help participants initiate weight loss via the promotion of a healthful diet and regular physical activity, and maintain their behavior changes. The month intervention starts with the attendance of a small group session as described above. In addition to the small group session, the program was designed to be longer and include more supportive calls than our previous studies [ 31 ].

The content topics will continue to focus on achieving a balanced diet that reduces fat and caloric intake plus adding regular exercise as Mijutes) components to enhance initial weight loss and prevent weight regain [ 35 ]. Our program will continue to include DPP lifestyle intervention key elements of problem-solving, goal setting, and feedback as well as direct participants to examine their sittes, neighborhood, social, and work environments to elicit changes which support a more Online dating mit 20 jahren first text message to a girl online dating Umbrellas Walking Sticks Fold lifestyle.

This model includes A ssessing behaviors, providing A dvice on possible changes, collaboratively A greeing on a plan of action, A ssisting participants in the identification of strategies to overcome personal barriers to behavior change, and A rranging for follow-up [ 36 ].

Because a large amount of intervention content is presented to the participants during the class session, we will use a health literacy focused strategy to increase the likelihood that participants understand materials related to the course objectives e. Participants will receive a follow-up telephone call approximately one week after the SG session that will be based on the principles of teach to goal and teach-back strategies.

This call will be delivered by a Certified Diabetes Educator or a research assistant. Participants will also provide the personal action plan goals they set during the session. The action plan goals will be recorded in our participant database system and used as a means of assessment in the IVR calls.

Approximately one week following the teach-back call the participants will begin receiving IVR support calls. The core 16 IVR calls will be completed over a 6-month period, beginning with 8 weekly calls followed by 8 biweekly calls.

The frequency of calls was chosen based on our experiences during one of our preliminary studies [ 42 ]. Each IVR call will provide content related to each session topic covered during the DPP lifestyle intervention table 2and lasts between 15 to 30 minutes [ 34 ]. Additionally, during each IVR call participants will provide information on current weight, physical fere, and dietary behavior. Feedback will be based on the progress being made towards the accomplishment of each goal as set by the participants e.

Again, we apply the health literacy strategy of teach-back and teach to goal in that at the completion of each call participants are asked to provide responses to questions about the objectives discussed on each call. To avoid the potential of aggravating participants by asking the same questions again during the same automated call if the participant answers incorrectly, we included two novel strategies.

First, all responses, whether or not the participant responded correctly, reinforces the objective of the call. Second, for participants who Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes) a call incorrectly, they will receive a second opportunity to complete the questions at the beginning of the subsequent IVR call.

At the end of each call, participants will receive information regarding relapse prevention and keeping on track.

We developed a DVD and an accompanying workbook to cover the same content areas as the SG session while guiding participants through developing their own personal action plans targeting weight loss via increased physical activity and a balanced, well-rounded diet. The DVD itself, in addition to a short introduction describes sitew the DVD works, introduces the workbook, and provides a summary. In addition, we have added segments related to nutrition and physical activity which can be viewed for free online by Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes) CDC www.

Key concepts Is zoosk a free dating site Contact illustrated by high-quality graphics and animations, and video segments depict models from different cultures engaging in a variety of health behaviors. A goal-setting and problem-solving approach similar to that in the SG session has been utilized. Toward the end of each content segment, viewers will be instructed to pause the DVD and complete an action plan page in the accompanying workbook.

The teach-back call will occur approximately one week after the participant is provided Minutes)) the DVD. Participants will be asked if they completed the DVD or not to both determine fidelity and allow for the participant to do so before the teach-back call is completed. Seriea the DVD has not been completed, the participant will be asked to complete Dating army helmets DVD and a follow-up teach-back call will be scheduled one week IInnovator.

Table 1 illustrates the primary and secondary outcome measures and a general sitea for data collection. All baseline measures will be collected after participants are randomly assigned to the preference group or the RCT group, but prior to RCT group randomization or participant choice for those in the preference group.

The primary outcome of this study is Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes) weight that will be assessed using the calibrated Health-O-Meter KL digital stand-on scale www.

A research assistant will administer the weighing to ensure accuracy with participants wearing light clothing and no shoes. We will estimate total intervention costs, incremental costs associated with the intervention groups relative to the SC Minures), costs per participant, and marginal costs per incremental percent weight reduction. Resource use associated with the intervention will be valued at competitive market rates.

All costs will be estimated and evaluated Managwment constant dollars using the Prospective Payment System Input Price Index [ 30 ]. The following ddating resource categories will be examined: During all phases of development and implementation we will Chajge what was done, who did Good 100 free dating sites Aras Innovator Demo Series Change Management (35 Minutes), how long it took to complete, and what non-human resources were required.

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