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Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes.

ABSTRACT: While strong and consistent evidence supports the role of lifestyle modification in the prevention and management of type 2 diabetes (T2DM), the best strategies for program implementation to support lifestyle modification within primary care remain to be determined. The objective of the study is to evaluate the implementation of an evidence-based self- management program for patients with T2DM within a newly established primary care network (PCN) environment.Using a non-randomized design, participants (total N?=?110 per group) will be consecutively allocated in bi-monthly blocks to either a 6-month self-management program lead by an Exercise Specialist or to usual care. Our primary outcome is self-reported physical activity and pedometer steps.The present study will assess whether a diabetes self-management program lead by an Exercise Specialist provided within a newly emerging model of primary care and linked to available community-based resources, can lead to positive changes in self-management behaviours for adults with T2DM. Ultimately, our work will serve as a platform upon which an emerging model of primary care can incorporate effective and efficient chronic disease management practices that are sustainable through partnerships with local community partners.ClinicalTrials.gov identifier: NCT00991380.

SUBMITTER: Johnson ST

PROVIDER: S-EPMC3441468 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes.

Johnson Steven T ST Mundt Clark C Soprovich Allison A Wozniak Lisa L Plotnikoff Ronald C RC Johnson Jeffrey A JA

BMC public health 20120619

<h4>Background</h4>While strong and consistent evidence supports the role of lifestyle modification in the prevention and management of type 2 diabetes (T2DM), the best strategies for program implementation to support lifestyle modification within primary care remain to be determined. The objective of the study is to evaluate the implementation of an evidence-based self- management program for patients with T2DM within a newly established primary care network (PCN) environment.<h4>Method</h4>Usi ...[more]

PMID: 22712881

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Project description:BACKGROUND:Rigorous evidence is needed regarding the best approach for increasing the uptake of Diabetes Canada's evidence-based recommendations to include low-glycemic index (GI) foods in daily meal planning as an effective dietary self-care strategy for glycemic control among people with type 2 diabetes (T2D). OBJECTIVE:This study aims to present the study design and baseline data from the Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI) trial, which was designed to evaluate the effectiveness of an enhanced GI-targeted nutrition education on GI-related knowledge and mean daily GI among adults with T2D in Edmonton, Alberta. METHODS:We used a pragmatic randomized controlled trial design and allocated 67 adults (aged ≥18 years) with T2D living in Edmonton, Alberta, Canada, to a control group that received standard printed copies of Canada's Food Guide and Diabetes Canada's GI resources or to an intervention group that received the same materials, plus a customized Web-based platform with 6 self-directed learning modules and print material. Each module included videos, links to reliable websites, chat rooms, and quizzes. Evidence-based GI concept information included GI values of foods and low-GI shopping, recipes, and cooking tips by a registered dietitian. In addition, support through email, text messaging (short message service), phone calls, or postal mail was provided to reinforce participants' learning. The primary outcome, average dietary GI, was assessed using 3-day food records. Additional measures including GI knowledge and self-efficacy, glycated hemoglobin (HbA1c), lipids, systolic blood pressure, body mass index (BMI; weight, height), waist circumference, and computer proficiency were assessed at baseline and at 3-month postintervention. RESULTS:Between November 2017 and February 2018, we contacted adults (aged ≥18 years) with T2D living in Edmonton, Alberta, screened and recruited eligible participants into the study. All data collection ended in June 2018. Overall, 64% (43/67) participants were males; mean age was 69.5 (SD 9.3) years, with a mean diabetes duration of 19.0 (SD 13.7) years. Mean BMI was 30.1 (SD 5.7) kg/m2, and mean HbA1c value was 7.1% (SD 1.2%). Data analysis was completed in December 2018. CONCLUSIONS:The GI concept is often difficult to teach. The HEALD-GI study aims to provide evidence in support of an alternative approach to translating the GI concept to adults with T2D. Findings from this study may help registered dietitians to better disseminate low-GI dietary recommendations using efficient and cost-effective, patient-centered approaches. Furthermore, evidence generated will contribute to addressing some of the controversies regarding the clinical usefulness of the GI concept. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11707.

Project description:IntroductionDiabetes is one of the most common serious chronic health conditions in the USA. People living with diabetes face multiple barriers to optimal diabetes care, including gaps in access to medical care and self-management education, diabetes distress, and high burden of treatment. Community paramedics (CPs) are uniquely positioned to support multidisciplinary care for patients with diabetes by delivering focused diabetes self-management education and support and bridging the gaps between patients and the clinical and community resources they need to live well with their disease.Methods and analysisWe will conduct a pragmatic single-arm prospective trial of a CP-led Diabetes Rescue, Engagement and Management (D-REM) programme that seeks to reduce diabetes distress. We will enrol 70 adults (≥18 years) with diabetes who have haemoglobin A1c (HbA1c)≥9.0%, experienced an emergency department (ED) visit or hospitalisation for any cause within the prior 6 months, and reside in areas with available CP support in Southeast Minnesota (Olmsted, Freeborn and Mower counties) and Northwest Wisconsin (Barron, Rusk and Dunn counties). Participants will be identified using Mayo Clinic electronic health records, contacted for consent and enrolled into the D-REM programme. Visit frequency will be individualised for each patient, but will be an average of four CP visits over the course of approximately 1 month. Outcomes will be change in diabetes distress (primary outcome), confidence in diabetes self-management, health-related quality of life, self-reported hypoglycaemia and hyperglycaemia, HbA1c, ED visits and hospitalisations. Outcomes will be assessed on enrolment, programme completion and 3 months after programme completion.Ethics and disseminationThe study was approved by Mayo Clinic Institutional Review Board. Findings will be disseminated through peer-reviewed publications and presentations. If demonstrated to be successful, this model of care can be implemented across diverse settings and populations to support patients living with diabetes.Trial registration numberNCT04385758.

Project description:BackgroundWomen with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level.Methods/designThe GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks).DiscussionThere is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population. Given the use of a telephonic case management model, our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM.

Dataset Information

Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes.

Publications

Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes.

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