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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: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.

Project description:IntroductionBlack British communities are disproportionately burdened by type 2 diabetes (T2D) and its complications. Tackling these inequalities is a priority for healthcare providers and patients. Culturally tailored diabetes education provides long-term benefits superior to standard care, but to date, such programmes have only been developed in the USA. The current programme of research aims to develop the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) culturally tailored T2D self-management programme for black British communities and to evaluate its delivery, acceptability and the feasibility of conducting a future effectiveness trial of HEAL-D.Methods and analysisInformed by Medical Research Council Complex Interventions guidance, this research will rigorously develop and evaluate the implementation of the HEAL-D intervention to understand the feasibility of conducting a full-scale effectiveness trial. In phase 1, the intervention will be developed. The intervention curriculum will be based on existing evidence-based T2D guidelines for diet and lifestyle management; codesign methods will be used to foster community engagement, identify the intervention's underpinning theory, identify the optimal structure, format and delivery methods, ascertain adaptations that are needed to ensure cultural sensitivity and understand issues of implementation. In phase 2, the intervention will be delivered and compared with usual care in a feasibility trial. Process evaluation methods will evaluate the delivery and acceptability of HEAL-D. The effect size of potential primary outcomes, such as HbA1c and body weight, will be estimated. The feasibility of conducting a future effectiveness trial will also be evaluated, particularly feasibility of randomisation, recruitment, retention and contamination.Ethics and disseminationThis study is funded by a National Institute of Health Research Fellowship (CDF-2015-08-006) and approved by National Health Service Research Ethics Committee (17-LO-1954). Dissemination will be through national and international conferences, peer-reviewed publications and local and national clinical diabetes networks.Trial registration numberNCT03531177; Pre-results.

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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