Trial Outcomes & Findings for Effect of Managing Problematic Eating Behaviours With Dietary Management on Chronic Disease Self-management (NCT NCT01804881)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-10-03

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Counseling n=16 Participants Craving change group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating	Wait List Control n=14 Participants wait list, offered program based on craving change(tm) material at end of study	Total n=30 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 4.9 • n=5 Participants	59.9 years STANDARD_DEVIATION 7.5 • n=7 Participants	61.7 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Canada	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants
Body Mass Index (kg/m^2)	31.2 kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants	32.8 kg/m^2 STANDARD_DEVIATION 5.1 • n=7 Participants	32 kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Intention to Treat analysis

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.

Outcome measures

Outcome measures
Measure	Wait List Control n=12 Participants wait list, offered group program at end of study	Lifestyle Counseling n=13 Participants Group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating
The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.	-3.2 Scores on a scale Standard Deviation 5.6	-1.7 Scores on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 6 weeks

Population: Intention to Treat analysis

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.

Outcome measures

Outcome measures
Measure	Wait List Control n=10 Participants wait list, offered group program at end of study	Lifestyle Counseling n=11 Participants Group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating
Change in Blood Pressure Blood Pressure - Systolic	-7.2 mm Hg Standard Deviation 15.3	-3.3 mm Hg Standard Deviation 15.5
Change in Blood Pressure Blood Pressure - Diastolic	-6 mm Hg Standard Deviation 6.8	0.6 mm Hg Standard Deviation 6.6

SECONDARY outcome

Timeframe: 6 weeks

Population: Intention to Treat analysis

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.

Outcome measures

Outcome measures
Measure	Wait List Control n=10 Participants wait list, offered group program at end of study	Lifestyle Counseling n=11 Participants Group intervention for dietary counseling, 6 group sessions Lifestyle counseling: Six week program to address problematic eating
Change in Weight	-0.87 kg Standard Deviation 1.06	-0.5 kg Standard Deviation 0.9

Adverse Events

Lifestyle Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

North York Family Health Team

Phone: 4164943003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place