Effect of Managing Problematic Eating Behaviours With Dietary Management on Chronic Disease Self-management

This study is not yet open for participant recruitment.
Verified March 2013 by University of Toronto Practice Based Research Network
Sponsor:
Information provided by (Responsible Party):
University of Toronto Practice Based Research Network
ClinicalTrials.gov Identifier:
NCT01804881
First received: March 2, 2013
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

Dietary management is an integral aspect of self care for many chronic diseases. Craving Change™ is a standard program already offered at many Family Health Teams (FHT) to patients interested in being more mindful of their food choices. The program helps patients understand why they have difficulty with modifying behaviours associated with diet, addresses the impact of emotion on eating behaviour and provides affect regulation strategies. Existing literature shows that emotion has a strong effect on food choice and that emotion regulation can lead to improvements in food choice. Craving Change™, however, is currently not selectively offered at FHTs to patients deemed to be at higher risk of cardiovascular disease and has not been evaluated in that context. For this study, we propose to 1) Selectively target patients at higher cardiometabolic risk; and 2) Evaluate an effect of the program (as modified to address chronic diseases) through a pilot Randomized Controlled Trial (RCT). If found to be effective, the modified Craving Change™ program, called "Beyond the Fork: A health-centred approach to managing chronic disease", could be broadly implemented within Family Health Teams.


Condition Intervention
Hypertension
Type 2 Diabetes
Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Craving Change-Plus on Chronic Disease Self-management: a Pilot RCT

Resource links provided by NLM:


Further study details as provided by University of Toronto Practice Based Research Network:

Primary Outcome Measures:
  • The change in EEQ (Emotional Eater Questionnaire) score is the primary outcome measure in this study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure the feasibility outcomes of this study [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Feasibility outcomes for this study include:

    • What percentage of physicians agreed to participate?
    • Were we able to identify patients meeting the study criteria?
    • How many participants agreed to participate in the study? (Will also document patients that were excluded by physician)
    • How many participants actually attended the sessions?
    • How many participants completed the sessions and all questionnaires?
    • Was there a sufficient change in the outcome of interest (EEQ) to enable sample size planning for a larger RCT?


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Craving change group intervention for dietary counseling, 6 group sessions
Behavioral: Lifestyle counseling
Six week program to address problematic eating
Other Name: Craving change program
Placebo Comparator: Wait list control
wait list, offered craving change program at end of study

Detailed Description:

This study is specifically focusing on Diabetes Mellitus Type 2 and Hypertension as these are chronic conditions in which dietary management is not only an integral part of managing the condition, but can also be a major factor in poor outcomes. Many of the current approaches and interventions used for treating these conditions provide patients with information about "what" eating behaviours to change and "how" to change them, such as through DEP (Diabetes Education Program) and CDSM (Chronic Disease Self-Management, aka Stanford).

The new intervention proposed in this study will be primarily based on the Craving Change™ program; the focus of which is to provide patients with an understanding of "why" it is difficult to change problematic eating behaviours. The new information that will be added is specific to chronic disease management. The original Craving Change™ program provides patients with information about how the environment, the physical body and emotional reactions can contribute to problematic eating behaviours thus increasing difficulty in changing those behaviours. The Craving Change™ program also provides patients with tools for overcoming the identified obstacles from the environment, physical body and emotional reactions in order to facilitate behaviour change. Patients who have a diagnosis of Diabetes Mellitus Type 2 and/or Hypertension and who are poorly controlled, are often required to make dietary changes to improve those conditions and often struggle to make the necessary dietary behaviour changes. By providing these patients with a behavioural intervention that uses the main components of the Craving Change™ program along with additional information specific to chronic disease management, the overall aim is to help patients improve control over the chronic condition with which they have been diagnosed.

As this is a feasibility study, the main goal is to determine if patients who are diagnosed with chronic disease(s) can be recruited successfully, stay in the program and experience a change in their perceptions of eating behaviours as a result of learning various strategies offered in the program. Specifically, this study is focusing on whether the strategies learned improve emotion regulation, which in turn could facilitate behaviour change. If the feasibility study is successful, the program can be evaluated in future studies to determine its effectiveness on more outcome measures.

Research question in this study: In a high risk population, does the "Beyond the Fork: A health-centered approach to managing chronic disease" program lead to decreased emotional reactivity in food choices when compared to usual care?

The modified Craving Change™ program may fill a treatment gap for those patients diagnosed with Diabetes Mellitus Type 2 or Hypertension who are poorly controlled and who struggle with changing eating habits, by providing these patients with information about "why" they have been struggling to change. If successful, the program could also become an additional part of evidence based treatment for managing chronic diseases.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All participants must meet the following criteria to be included in the study:

  • able to consent,
  • currently rostered to a physician in one of the three participating FHTs
  • have never attended the Craving Change™ program,
  • live with Hypertension and/or Type 2 Diabetes,
  • and meet at least 2 out of 3 of the following criteria: A1C (last) >7.5% Systolic BP (last) > 140 LDL (last)> 4 (in non-diabetics) or >2 (for diabetics)

Exclusion Criteria:

  • Physician opted out of the study, these patients will not be approached
  • Participant does not consent
  • Participant already attended Craving Change™ or modified Craving Change™ program in the past
  • Participant does not speak English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01804881

Contacts
Contact: Danuta Southgate, MSW, RSW 416-494-3003 ext 130 dsouthgate@nyfht.com

Locations
Canada, Ontario
North York Family Health Team Not yet recruiting
Toronto, Ontario, Canada, M3B 3S6
Contact: Danuta Southgate, MSW, RSW    416-494-3003 ext 130    dsouthgate@nyfht.com   
Principal Investigator: Danuta Southgate, MSW, RSW         
Sponsors and Collaborators
University of Toronto Practice Based Research Network
Investigators
Principal Investigator: Danuta Southgate, MSW, RSW North York Family Health Team
  More Information

Publications:
Responsible Party: University of Toronto Practice Based Research Network
ClinicalTrials.gov Identifier: NCT01804881     History of Changes
Other Study ID Numbers: 13-0225
Study First Received: March 2, 2013
Last Updated: March 19, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Chronic Disease
Diabetes Mellitus, Type 2
Hypertension
Disease Attributes
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014