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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Toronto Practice Based Research Network
ClinicalTrials.gov Identifier:
NCT01804881
First received: March 2, 2013
Last updated: June 4, 2014
Last verified: June 2014
  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 Beyond the Fork 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 weeks ] [ Designated as safety issue: No ]

    The EEQ is a10-item validated questionnaire measuring the degree of interaction between food intake and emotion. Scores on a scale between baseline score and score after 6 weeks was measured.

    The EEQ is scored as follows:

    Values: Never = '0'; Sometimes = '1'; Generally = '2'; Always = '3' Score between 0-5: "You are a non-emotional eater. Score between 6-10: "You are a low emotional eater. Score between 11-20: "You are an emotional eater. Score between 21-30: "You are a very emotional eater. The participants completed the EEQ at baseline and it was scored. After 6 weeks the participants completed the EEQ again and it was scored again. The participants' baseline score was compared to the score at week 6. The goal was for scores to reduce. If participants' scores were higher at week 6, that could mean that the intervention was not successful. If the participants' scores were lower at week 6, that could mean that the intervention was successful.



Secondary Outcome Measures:
  • Change in Blood Pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Blood Pressure was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to have blood pressure taken again.

  • Change in Weight [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Weight was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to be re-weighed.


Enrollment: 30
Study Start Date: March 2013
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Group program using Craving Change(tm) material was the intervention for dietary counseling, 6 group sessions
Behavioral: Lifestyle counseling
Six week program to address problematic eating
Other Name: Group program using Craving Change(tm) material
Placebo Comparator: Wait list control
Wait list, offered group program using Craving Change(tm) material 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 material from 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. Our primary outcome measure is the EEQ ("Emotional Eater Questionnaire"); which is a validated 10 item questionnaire measuring the degree of interaction between emotion and food choice.

This study is a Randomized Control Trial. The setting is 3 Family Health Teams in the Greater Toronto Area. Eligibility criteria includes rostered status to the Family Health Team, no previous participation in a program using Craving Change™, diagnosis of Diabetes Mellitus Type 2 and/or Hypertension, and 2 of 3 high A1c / BP / LDL. Patients are identified using Electronic Medical Records (EMRs) and those patients meeting criteria are sent an EEQ via mail. Patients consenting to participation are invited to intake at which blood pressure (BP), height/weight/waist circumference (ht/wt/wc) is measured and patients are randomized to immediate participation in the program or to wait list control. After 6 weeks EEQ is re-administered, and BP, ht/wt/wc is measured again.

  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 a program using Craving Change™ material
  • 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 a program using Craving Change™ material in the past
  • Participant does not speak English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804881

Locations
Canada, Ontario
North York Family Health Team
Toronto, Ontario, Canada, M3B 3S6
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
Results First Received: February 7, 2014
Last Updated: June 4, 2014
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 July 22, 2014