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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Mar 2013
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 2, 2013
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
April 23, 2014
CompletedOctober 3, 2018
September 1, 2018
4 months
March 2, 2013
February 7, 2014
September 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Secondary Outcomes (2)
Change in Blood Pressure
6 weeks
Change in Weight
6 weeks
Study Arms (2)
Lifestyle counseling
EXPERIMENTALGroup program using Craving Change(tm) material was the intervention for dietary counseling, 6 group sessions
Wait list control
PLACEBO COMPARATORWait list, offered group program using Craving Change(tm) material at end of study
Interventions
Six week program to address problematic eating
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North York Family Health Team
Toronto, Ontario, M3B 3S6, Canada
Related Publications (2)
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.
PMID: 20460650BACKGROUNDGaraulet 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.
PMID: 22732995BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small sample size is limitation and was affected by small number recruited due to some participants declining participation due to being unable to come in for the day/time group program was offered and some participants dropped out during the study.
Results Point of Contact
- Title
- Principal Investigator
- Organization
- North York Family Health Team
Study Officials
- PRINCIPAL INVESTIGATOR
Danuta Southgate, MSW, RSW
North York Family Health Team
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2013
First Posted
March 5, 2013
Study Start
March 1, 2013
Primary Completion
July 1, 2013
Study Completion
October 1, 2013
Last Updated
October 3, 2018
Results First Posted
April 23, 2014
Record last verified: 2018-09