- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804881
Effect of Managing Problematic Eating Behaviours With Dietary Management on Chronic Disease Self-management
Effect of Beyond the Fork on Chronic Disease Self-management: a Pilot RCT
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M3B 3S6
- North York Family Health Team
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lifestyle counseling
Group program using Craving Change(tm) material was the intervention for dietary counseling, 6 group sessions
|
Six week program to address problematic eating
Other Names:
|
PLACEBO_COMPARATOR: Wait list control
Wait list, offered group program using Craving Change(tm) material at end of study
|
Six week program to address problematic eating
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.
Time Frame: 6 weeks
|
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. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Blood Pressure
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Change in Weight
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Danuta Southgate, MSW, RSW, North York Family Health Team
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0225
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
BayerCompletedPrimary HypertensionChina
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Lifestyle counseling
-
York UniversityPublic Health Agency of Canada (PHAC)Unknown
-
Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart AssociationCompletedStroke | Multiple Sclerosis | Rheumatoid ArthritisUnited States
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI)CompletedHypertension | Obesity | Diabetes | Metabolic Syndrome | Hypercholesterolemia
-
Mayo ClinicCompleted
-
UKK InstituteFinnish Institute of Occupational Health; Academy of Finland; Vitalmed Research...CompletedEffects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers (SF-Truck)Abdominal ObesityFinland
-
Federal University of São PauloUnknownPain | Myofascial Pain | Facial Pain | Therapeutic Exercise | Temporomandibular Disorder SyndromeBrazil
-
Maura PalmeryUniversidad Católica San Antonio de Murcia; Research Centre for Food and Nutrition...UnknownMedication AdherenceItaly, Spain
-
The Miriam HospitalCompleted
-
Equipo Multidisciplinar Sanitario CS FoietesCompletedDiabetes Mellitus, Type 2