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

• Sponsor: University of Toronto Practice Based Research Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT01804881
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 4.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Type 2 Diabetes	Behavioral: Lifestyle counseling	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Beyond the Fork on Chronic Disease Self-management: a Pilot RCT
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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	Behavioral: Lifestyle counseling; Six week program to address problematic eating; Other Names: Group program using Craving Change(tm) material

Outcome Measures

Primary Outcome Measures

1. The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study. [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.

Secondary Outcome Measures

1. Change in Blood Pressure [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.

2. Change in Weight [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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, López-Guimera G, Sánchez-Carracedo D, Corbalán-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.

• Responsible Party: University of Toronto Practice Based Research Network
• ClinicalTrials.gov Identifier: NCT01804881
• Other Study ID Numbers: 13-0225
• First Posted: Mar 5, 2013
• Last Update Posted: Oct 3, 2018
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Chronic Disease

Study Results

Participant Flow

Arm/Group Title	Lifestyle Counseling	Wait List Control
Arm/Group Description	Craving change group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating	wait list, offered program based on craving change(tm) material at end of study
Period Title: Overall Study
STARTED	16	14
COMPLETED	11	10
NOT COMPLETED	5	4

Baseline Characteristics

Arm/Group Title	Lifestyle Counseling	Wait List Control	Total
Arm/Group Description	Craving change group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating	wait list, offered program based on craving change(tm) material at end of study	Total of all reporting groups
Overall Participants	16	14	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.2 (4.9)	59.9 (7.5)	61.7 (6.2)
Sex: Female, Male (Count of Participants)
Female	14 87.5%	7 50%	21 70%
Male	2 12.5%	7 50%	9 30%
Region of Enrollment (participants) [Number]
Canada	16 100%	14 100%	30 100%
Body Mass Index (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.2 (5.1)	32.8 (5.1)	32 (5.1)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intention to Treat analysis

Arm/Group Title	Lifestyle Counseling	Wait List Control
Arm/Group Description	Craving change group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating	wait list, offered craving change program at end of study
Measure Participants	13	12
Mean (Standard Deviation) [Scores on a scale]	-1.7 (2.6)	-3.2 (5.6)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intention to Treat analysis

Arm/Group Title	Lifestyle Counseling	Wait List Control
Arm/Group Description	Group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating	wait list, offered group program at end of study
Measure Participants	11	10
Blood Pressure - Systolic	-3.3 (15.5)	-7.2 (15.3)
Blood Pressure - Diastolic	0.6 (6.6)	-6 (6.8)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intention to Treat analysis

Arm/Group Title	Lifestyle Counseling	Wait List Control
Arm/Group Description	Group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating	wait list, offered group program at end of study
Measure Participants	11	10
Mean (Standard Deviation) [kg]	-0.5 (0.9)	-0.87 (1.06)

Adverse Events

Time Frame	6 months
Arm/Group Title	Lifestyle Counseling		Wait List Control
Arm/Group Description	Craving change group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating		wait list, offered craving change program at end of study
All Cause Mortality
	Lifestyle Counseling		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lifestyle Counseling		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Lifestyle Counseling		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.