Effect of Managing Problematic Eating Behaviours With Dietary Management on Chronic Disease Self-management
Primary Purpose
Hypertension, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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
Sites / Locations
- North York Family Health Team
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lifestyle counseling
Wait list control
Arm Description
Group program using Craving Change(tm) material was the intervention for dietary counseling, 6 group sessions
Wait list, offered group program using Craving Change(tm) material at end of study
Outcomes
Primary Outcome Measures
The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.
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
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
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.
Full Information
NCT ID
NCT01804881
First Posted
March 2, 2013
Last Updated
September 5, 2018
Sponsor
University of Toronto Practice Based Research Network
1. Study Identification
Unique Protocol Identification Number
NCT01804881
Brief Title
Effect of Managing Problematic Eating Behaviours With Dietary Management on Chronic Disease Self-management
Official Title
Effect of Beyond the Fork on Chronic Disease Self-management: a Pilot RCT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toronto Practice Based Research Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Group program using Craving Change(tm) material was the intervention for dietary counseling, 6 group sessions
Arm Title
Wait list control
Arm Type
Placebo Comparator
Arm Description
Wait list, offered group program using Craving Change(tm) material at end of study
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Other Intervention Name(s)
Group program using Craving Change(tm) material
Intervention Description
Six week program to address problematic eating
Primary Outcome Measure Information:
Title
The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Blood Pressure
Description
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.
Time Frame
6 weeks
Title
Change in Weight
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danuta Southgate, MSW, RSW
Organizational Affiliation
North York Family Health Team
Official's Role
Principal Investigator
Facility Information:
Facility Name
North York Family Health Team
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20460650
Citation
Evers C, Marijn Stok F, de Ridder DT. Feeding your feelings: emotion regulation strategies and emotional eating. Pers Soc Psychol Bull. 2010 Jun;36(6):792-804. doi: 10.1177/0146167210371383. Epub 2010 May 11.
Results Reference
background
PubMed Identifier
22732995
Citation
Garaulet M, Canteras M, Morales E, Lopez-Guimera G, Sanchez-Carracedo D, Corbalan-Tutau MD. Validation of a questionnaire on emotional eating for use in cases of obesity: the Emotional Eater Questionnaire (EEQ). Nutr Hosp. 2012 Mar-Apr;27(2):645-51. doi: 10.1590/S0212-16112012000200043.
Results Reference
background
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Effect of Managing Problematic Eating Behaviours With Dietary Management on Chronic Disease Self-management
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