A Randomized Controlled Trial to Evaluate the Effectiveness of the Pure Prairie Living Program - A Lifestyle Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Hb A1C
研究概览
简要总结
In Canada, there is a growing burden of type 2 diabetes (T2D). Approaches to implement nutrition recommendations and promote sustainable eating behaviours are required. The investigating research team developed an educational curriculum that includes practical information about Eating Well with Canada's Food Guide, portion control and food label reading. The research team also developed a cookbook, "Pure Prairie Eating Plan" which translates the Canadian Diabetes Association Clinical Practice Guidelines into a practical menu plan with recipes, grocery lists and cooking tips. These resources promote behaviour change and skill development to independently manage diabetes. These resources have been successfully employed in a clinical study trial conducted at the University of Alberta and in a pilot project at the community (Pure Prairie Living Program -PPLP), and showed beneficial effects in management of diabetes among participants. The objective of this study is to implement and evaluate the PPLP in a community level, to promote healthy lifestyle among people with T2D in the general community. To meet the study objective, 60 adult participants with diagnosed T2D will be recruited from three different primary care networks (total of 180 participants) and at each site 30 participants will be randomized into the education intervention (PPLP) and 30 will be the wait-listed controls (CON) receiving usual care. PPLP participants will attend 5, biweekly education sessions and a grocery store tour scheduled over a period of 3 months.The benefits of the lifestyle intervention on physiological indicators (BMI, Haemoglobin A1C, blood lipids, blood pressure) and lifestyle choices (adherence to dietary recommendations, self-efficacy and participation in physical activity) will be examined.
详细描述
Overall Goal: To implement and evaluate the effectiveness of a lifestyle intervention (LI) tailored to Albertans' environment called the Pure Prairie Living Program (PPLP) in primary care network (PCN) settings. The PPLP delivers innovation in the concept (based on the 4-A Framework), the setting (PCNs) and nutrition evaluation tools (for Dietary Adherence - PDAQ).
Background: In Canada, there is a growing burden of type 2 diabetes (T2D). One in four Canadians has diabetes or pre-diabetes and this number is projected to be 1 in 3 by 2020. The associated economic burden is estimated to be $16.9 billion in 2020.
Adopting a healthy lifestyle can prevent and also help effectively manage T2D. Several dietary LI in the recent decades have targeted achieving a healthy body weight, participation in physical activity, and healthy eating as primary goals of their intervention trials to delay the progression of the disease or to minimize co-morbidities associated with T2D. Although some of the programs have achieved success in improving health outcomes and delaying the risk of co-morbidities, sustaining long-term changes by the participants after completion of intervention trials is challenging.
Many interventions attempt to personalize treatment based on an individual's preferences and circumstances but fewer consider individual factors within a broader framework of health determinants that includes local food Availability, financially/physically Accessibility, culturally Acceptability and nutritionally Adequacy (4A Framework). Failure to achieve long-term adherence may be influenced by these social and environmental health determinants. Further, Healthcare Professionals (HCP) are designated with the primary responsibility of educating patients to prevent, treat and manage chronic diseases. However HCPs often lack the training, skills, confidence, and time required to implement effective LI and primary care delivery models often lack the required structure and organization for such LI. Few studies consider the health care system-level changes that are required to offer sustainable, high quality LI or programs. Hence to achieve sustained adoption and maintenance of the effects of a LI at a system level requires careful planning (considering the barriers for change, ongoing support to personnel and participants, adopting a framework for behaviour change, improving self-efficacy), implementation and evaluation of the interventions.
In Alberta, Primary Care Networks (PCNs) were implemented to provide citizens access to a multi-disciplinary care team of clinicians, including dietitians. One of the goals of PCNs is to increase the emphasis on health promotion, disease and injury prevention, and care of patients with complex problems or chronic disease. Therefore, the PCN setting is ideal for implementation of LI. The investigators will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework in planning and evaluating the PPLP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants who have consented to participate in this study will be assigned a number, those who receive an even number will be assigned to the intervention arm and those who receive an odd number will be in the control arm.
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes, Able to read and write in English
排除标准
- •Type 1 Diabetes, having severe gastrointestinal issues or diabetes complications requiring specialized diet
研究组 & 干预措施
Pure Prairie Living Program
Participants in the intervention arm will participate in 5 weekly education sessions ( 2hours / session) on nutrition education and healthy lifestyle.
干预措施: Pure Prairie Living Program (Behavioral)
Wait Listed Control
Participants in the control arm will not receive any intervention.
结局指标
主要结局
Change in Hb A1C
时间窗: Baseline, 3month, 6 month
Hb A1c will be measured at baseline, after intervention at 3 and 6 months. Changes in the test result pre and post intervention will be calculated
次要结局
- Height (m)(Baseline)
- Changes in Lipid Panel Test(Baseline, 3 and 6 months)
- Physical Activity Questionnaire(Baseline, 3 and 6 months.)
- Changes in Blood Pressure(Baseline, 3 and 6 months)
- Changes in BMI(kg/m^2)(Baseline, 3 and 6 months)
- 10 Item Perceived Dietary Adherence Questionnaire(Baseline, 3 and 6 months.)
- 8 item Nutrition Self Efficacy(Baseline, 3 and 6 months.)
- 5 Item Quality of Life(Baseline, 3 and 6 months.)
- Pedometer Steps Record(Baseline, 3 and 6 months.)
- Change in Weight(Baseline, 3 and 6 months.)
研究者
Catherine Chan
Professor, Dept. of Agriculture Food and Nutritional Sciences
University of Alberta
