A Trial to Evaluate the Effectiveness of the Pure Prairie Living Program

NCT03043859 | Completed

• 1 other identifier: Pro00070736
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hb A1C

  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

  Baseline, 3month, 6 month

Secondary Outcomes (10)

• 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.

• Physical Activity Questionnaire

  Baseline, 3 and 6 months.

• Pedometer Steps Record

  Baseline, 3 and 6 months.

Study Arms (2)

Pure Prairie Living Program

EXPERIMENTAL

Participants in the intervention arm will participate in 5 weekly education sessions ( 2hours / session) on nutrition education and healthy lifestyle.

Behavioral: Pure Prairie Living Program

Wait Listed Control

NO INTERVENTION

Participants in the control arm will not receive any intervention.

Interventions

Pure Prairie Living Program BEHAVIORAL

Education session (n=5) on healthy eating, menu planning and skill building for effective diabetes management

Pure Prairie Living Program

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes, Able to read and write in English

You may not qualify if:

• Type 1 Diabetes, having severe gastrointestinal issues or diabetes complications requiring specialized diet

Sponsors & Collaborators

• University of Alberta: lead
• Sherwood Park Strathcona County Primary Care Network, Alberta: collaborator

Study Sites (1)

Sherwood Park Primary Care Network

Sherwood Park, Alberta, T8H 0V3, Canada

Location

Related Publications (2)

• Asaad G, Soria-Contreras DC, Bell RC, Chan CB. Effectiveness of a Lifestyle Intervention in Patients with Type 2 Diabetes: The Physical Activity and Nutrition for Diabetes in Alberta (PANDA) Trial. Healthcare (Basel). 2016 Sep 27;4(4):73. doi: 10.3390/healthcare4040073.

  PMID: 27690122 BACKGROUND

• Raine KD. Determinants of healthy eating in Canada: an overview and synthesis. Can J Public Health. 2005 Jul-Aug;96 Suppl 3(Suppl 3):S8-14, S8-15. doi: 10.1007/BF03405195.

  PMID: 16042158 BACKGROUND

Study Officials

• Cathy Chan, PI

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept. of Agriculture Food and Nutritional Sciences

Model Details: This is a randomized, controlled trial of two arms \[intervention (PPLP) and wait-listed controls (CON)\]. Baseline data will be collected from all participants. PPLP participants will then receive 5 educational session on healthy eating, behaviour change and lifestyle in addition to usual care, whereas the controls will only receive usual care (no education intervention). Data for primary outcomes will be collected at 3 and 6 month period (from baseline). After the 6 month assessment all participants from the Control group will then recieve intervention and will complete the 3 and 6 month assessments.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 6, 2017
• Study Start: May 9, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)