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Overweight and Obesity5AsTNCT01967797

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

A study testing 5As Team Intervention in people with Overweight and Obesity, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight and Obesity
What is being tested?
5As Team Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
1 siteCanada
Study dates
21 Oct 2013to 22 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University Of Alberta

    Edmonton, Alberta

Other trials in Canada

About this study

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.

Read more

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).

Read the detailed description

Obesity is a public health problem as it is associated with many co-morbidities, decreased life expectancy and high health care costs. In 2008, prevalence of obesity and overweight, combined, in Canada was 62.1%. Supported by Canadian Institute of Health Research (CIHR) and Public Health Agencies of Canada Innovation strategy, the Canadian Obesity Network developed a novel tool for obesity counseling and management in primary care settings know as the "5As of Obesity Management". However, despite current dissemination strategies and extensive provider education in the 5As, the uptake of current practices for weight management has been inconsistent. Evidence suggests that treating obesity can reduce the incidence of a number of chronic diseases, and that obesity is not effectively managed in our current health care system.This project was co-created by, and will be implemented with, our partners the Southside Primary Care Network (SSPCN).

The main goal of this project is to develop and evaluate a pragmatic intervention called the 5As Team Intervention(5AsT) which acts on health professionals, forming them into a 6 month learning collaborative that undergoes an iterative, action based process to address facilitators and barriers to weight management.

Primary Objective:

Increase the number of weight management visits conducted by SSPCN Registered Nurses/Nurse Practitioners (RN/NPs).

Primary questions:

  1. Does the 5As Team (5AsT) intervention affect the number of weight management visits conducted by SSPCN practitioners (RN/NP) in their SSPCN practice?
  2. Under what circumstances does the 5AsT intervention affect the number of weight management visits conducted by the SSPCN practitioners?
  3. Are changes in weight management visit rates sustained following the intervention period?
  4. What is the impact of implementation of 5AsT on practice level outcomes - on unique 5As Teams and the SSPCN?

Secondary Objective:

To evaluate the impact of SSPCN weight management programming, with and without this 5AsT intervention, on patient important outcomes including: weight (BMI), blood pressure, self reported health status (EQ5D,SF-12), and patient-reported measures of chronic disease management for obesity (modified PACIC), as well as completion of appropriate laboratory studies (HbA1c for diabetics, fasting glucose, and cholesterol panel for age>40).

Design: This is a mixed methods, pragmatic cluster randomized trial in regular practice. The quantitative portion focuses on provider weight management visits, and patient-important outcomes above. For the patient study, 2 primary patient outcomes the study is powered for are BMI and SF-12, the remainder above are secondary patient outcomes. The qualitative portion seeks to understand the implementation process and the efficacy of the 5AsT intervention. Practitioners affiliated with different clinical groups will be randomized to intervention or control. All practitioners receive a robust didactic training program in weight management. The intervention group practitioners will participate in a 6 month 5AsT learning collaborative to address barriers to implementation of effective weight management strategies based upon the 5As of Obesity Management tool kit. Interested patients presenting to the central SSPCN programming will be recruited to participate in the study. There is no study intervention on the patients; the study will only observe how they are doing on their weight management journey in the SSPCN - whether they come from an intervention or control practice group. We will conduct a rigorous qualitative analysis of the intervention process using numerous qualitative tools to assess both the intervention itself and participant views. A qualitative plan has been created that outlines the use of field notes, focus groups and interviews to collect data and the use of Thematic Analysis and Nvivo software for analysis.

Intervention: The 5As Team (5AsT) Program intervention in this study is based on behavior change theory. The Teams are groups of SSPCN practitioners (RN/NP, Social work, Registered Dietitian) who practice collaboratively in the community (N=25). The intervention group (N=12 teams) 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.

Setting: The SSPCN is one of the largest Primary Care Networks (PCN) in Alberta, which serves an ethnically and socially diverse population from 45 community family practices. The SSPCN centralizes programs that are not available at independent family practices. Also, each primary care center has a SSPCN team of personnel who reports directly to the SSPCN, and are responsible for delivering services to patients from that patient catchment.

Being tested
5As Team Intervention
Keywords
Obesity
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5As Team InterventionBehavioural

    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.

Study groups in NCT01967797
Study groupRoleWhat they receive
5As Team InterventionExperimentalThe 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.
Receives: Behavioral: 5As Team Intervention
ControlNo interventionThough the controls will have knowledge of the '5A's of Obesity Management', they will not be receiving 5As Team Intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of weight management visits/ practitioner Full Time Equivalent(FTE)

    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.

    Measured: Data will be collected monthly and analyzed at 6, 12 and 18 Months

  2. Change in BMI

    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.

    Measured: 3,6,12,and 18 month where possible

  3. Change in Self-reported health measures-SF12

    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.

    Measured: 3,6,12 months and 18 months where possible

Secondary outcomes (2)
  1. Change in Self-reported health measures- EQ5D

    PATIENT STUDY - In order to account for short term health concerns, we are co-administering the EQ-5D-5L.

    Measured: 3,6,12 months and 18 months where possible

  2. Change in PACIC Score

    Patient report of health care providers' management of weight as a chronic medical condition. (modified PACIC score)

    Measured: 3 months, 6 months, 12 months, and 18 months where possible

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2013 (estimated)
  2. Study start21 Oct 2013
  3. Primary completion30 Jan 2015
  4. Study completion22 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01967797
Sponsor's protocol ID
RES 0014622
Acronym
5AsT
Status last verified
Mar 2016
First submitted
18 Oct 2013
Last updated
16 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Campbell-Scherer DL, Asselin J, Osunlana AM, Ogunleye AA, Fielding S, Anderson R, Cave A, Johnson JA, Sharma AM. Changing provider behaviour to increase nurse visits for obesity in family practice: the 5As Team randomized controlled trial. CMAJ Open. 2019 May 30;7(2):E371-E378. doi: 10.9778/cmajo.20180165. Print 2019 Apr-Jun.

    PubMed 31147378
  • Luig T, Asselin J, Sharma AM, Campbell-Scherer DL. Understanding Implementation of Complex Interventions in Primary Care Teams. J Am Board Fam Med. 2018 May-Jun;31(3):431-444. doi: 10.3122/jabfm.2018.03.170273.

    PubMed 29743226
  • Asselin J, Salami E, Osunlana AM, Ogunleye AA, Cave A, Johnson JA, Sharma AM, Campbell-Scherer DL. Impact of the 5As Team study on clinical practice in primary care obesity management: a qualitative study. CMAJ Open. 2017 Apr 26;5(2):E322-E329. doi: 10.9778/cmajo.20160090.

    PubMed 28450428
  • Ogunleye A, Osunlana A, Asselin J, Cave A, Sharma AM, Campbell-Scherer DL. The 5As team intervention: bridging the knowledge gap in obesity management among primary care practitioners. BMC Res Notes. 2015 Dec 22;8:810. doi: 10.1186/s13104-015-1685-8.

    PubMed 26695407
  • Campbell-Scherer DL, Asselin J, Osunlana AM, Fielding S, Anderson R, Rueda-Clausen CF, Johnson JA, Ogunleye AA, Cave A, Manca D, Sharma AM. Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial. Implement Sci. 2014 Jun 19;9:78. doi: 10.1186/1748-5908-9-78.

    PubMed 24947045

Questions about this trial

What is this clinical trial studying?

A study testing 5As Team Intervention in people with Overweight and Obesity, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01967797, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.

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