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Trial record 4 of 94032 for:    5

Implementation and Validation of the "5As Framework of Obesity Management" in Primary Care. "5AsT" (5AsT)

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ClinicalTrials.gov Identifier: NCT01967797
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
Edmonton South Side Primary care network
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

The main goal of this project is to develop, implement and evaluate the 5As Team intervention (5AsT)for healthcare practitioners to improve their weight management patient encounters and improve patient health outcomes. The 5As of Obesity Management suite of tools is a robust, evidence-based approach to weight management, however its implementation and uptake has been heterogeneous in primary care.

This project was co-created by, and will be implemented with, our partners the Southside Primary Care Network (SSPCN). A needs assessment on weight management by the SSPCN revealed the need to change provider practice to increase the number of weight management visits. Despite a robust didactic training session on weight management for all providers, which includes the 5As, the uptake in practice has been highly heterogeneous. Thus, the 5AsT intervention to address the implementation of the 5As of Obesity Management in clinical practice was developed by the collaborative team. The SSPCN consists of 25 autonomous groups of multidisciplinary professionals that provide service to a defined group of patients within the SSPCN.

The 5As Team consists of multidisciplinary providers (Registered Nurse/ Nurse Practitioner, dietician, mental health worker) who work collaboratively. The intervention is a learning collaborative where these 12 different 5AsTs get together to work to address facilitators and barriers to weight management in their settings over a 6 month period. Half of the teams (N=12) will remain as controls and deliver usual care. They serve as a comparison group for the 5AsTs. This mixed methods study's primary outcomes will assess the change in provider practice and the effectiveness of the intervention and implementation.

To assess the impact of 5AsT on patients, we will recruit patients presenting to the central SSPCN programming, We will not intervene directly on patients; we will observe the impact of the 5AsT and SSPCN programming on their health outcomes for a minimum of 6 months, and where possible for 18 months. Data collected includes demographics, weight (BMI), waist circumference, vital signs,and Short Form-12 (SF-12,these measures are routinely measured in the SSPCN), EuroQol-5 dimensions 5 Level (EQ-5D-5L), modified patient assessment of chronic illness (PACIC), and observed adherence to routine clinical care for guideline recommended laboratory monitoring (cholesterol panel, fasting glucose, HbA1c, where appropriate).


Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: 5As Team Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implementation and Validation of the "5As Framework of Obesity Management" in Primary Care. "5AsT"
Actual Study Start Date : October 21, 2013
Actual Primary Completion Date : January 30, 2015
Actual Study Completion Date : December 22, 2016

Arm Intervention/treatment
Experimental: 5As Team Intervention
The intervention group will participate in an additional 6 month intensive learning collaborative model designed around the 5As of obesity management, but which addresses areas identified as barriers (i.e. weight bias, clinical environment, clinic processes & team based care, mental health, counseling around emotional eating, caregiver fatigue, designing appropriate patient follow-up, and additional topics identified by the professionals). A clinical Champion identified by our partner SSPCN will be available to provide 1:1 support and coaching of the practitioners & teams as needed. The practitioners will work collaboratively to do their own needs assessment, and will identify additional resources or tools that they need to overcome the barriers to weight management in their setting. The research team will use a Practice Facilitation model to provide additional resource and support to the change process for the practitioners.
Behavioral: 5As Team Intervention
The intervention group will participate in an additional 6 month intensive learning collaborative model designed around the 5As of obesity management, but which addresses areas identified as barriers (i.e. weight bias, clinical environment, clinic processes & team based care, mental health, counseling around emotional eating, caregiver fatigue, designing appropriate patient follow-up, and additional topics identified by the professionals). A clinical Champion identified by our partner SSPCN will be available to provide 1:1 support and coaching of the practitioners & teams as needed. The practitioners will work collaboratively to do their own needs assessment, and will identify additional resources or tools that they need to overcome the barriers to weight management in their setting. The research team will use a Practice Facilitation model to provide additional resource and support to the change process for the practitioners.

No Intervention: Control
Though the controls will have knowledge of the '5A's of Obesity Management', they will not be receiving 5As Team Intervention.



Primary Outcome Measures :
  1. Number of weight management visits/ practitioner Full Time Equivalent(FTE) [ Time Frame: Data will be collected monthly and analyzed at 6, 12 and 18 Months ]
    PROVIDER INTERVENTION STUDY- This is routine operational data collected by the SSPCN on all encounters conducted by all practitioners. Providers are blinded to the outcome measure.

  2. Change in BMI [ Time Frame: 3,6,12,and 18 month where possible ]
    PATIENT STUDY - Primary outcome measure. All patients receive SSPCN health courses. This measure compares patients from the 5AsT clinics and the control clinics to see whether they have greater weight loss, and more success in sustained weight management. This will also be assessed by the number of interactions they have for weight management over the time frame.

  3. Change in Self-reported health measures-SF12 [ Time Frame: 3,6,12 months and 18 months where possible ]
    PATIENT STUDY-All patients receive central SSPCN health programming. This compares those from 5AsT Team clinics with those from control clinics to see whether they have greater self-reported health measures and more success with sustained improvement. This will also be assessed by the number of interactions they have for weight management over the time frame.


Secondary Outcome Measures :
  1. Change in Self-reported health measures- EQ5D [ Time Frame: 3,6,12 months and 18 months where possible ]
    PATIENT STUDY - In order to account for short term health concerns, we are co-administering the EQ-5D-5L.

  2. Change in PACIC Score [ Time Frame: 3 months, 6 months, 12 months, and 18 months where possible ]
    Patient report of health care providers' management of weight as a chronic medical condition. (modified PACIC score)


Other Outcome Measures:
  1. Qualitative Description of the Implementation Process [ Time Frame: 12 months ]

    SSPCN Personnel randomized to the study intervention group will be trained for a 6 month period. During training, there will be collection of field notes, 1:1 interviews and focus groups for consenting practitioners. The data will be analyzed on a weekly basis to identify themes concerning the efficacy of the intervention process and practitioner behavior change. This will be used to continually refine the intervention, and describe how and why it is/not working.

    Following the 12 months (6 month intervention, 6 months of monitoring to assess sustainability) both qualitative and quantitative results will be combined to explore correlation. This will allow for more in-depth exploration of any variation in results.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients over 18 years
  • BMI ≥ 25
  • Enrolling in PCN programs for overweight/ obesity or depression able and willing to give written informed consent in English

Exclusion Criteria:

  • Children and pregnant women
  • Patients whose obesity is co-managed by an obesity specialist or tertiary care center
  • Patients who are unable to participate in regular clinic visits or programs due to geographic, social or physical reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967797


Locations
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Canada, Alberta
University Of Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Edmonton South Side Primary care network
Alberta Innovates Health Solutions
Investigators
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Principal Investigator: Arya M Sharma, MD,PhD University of Alberta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01967797     History of Changes
Other Study ID Numbers: RES 0014622
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: March 2016
Keywords provided by University of Alberta:
Obesity
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms