Trial Outcomes & Findings for Eating Behaviour in Crohn's Disease (NCT NCT02379117)
NCT ID: NCT02379117
Last Updated: 2019-07-15
Results Overview
The primary endpoints for this study will be food intake as measured by one telephone-administered 24-h dietary recall. Total calorific intake will be calculated.
COMPLETED
61 participants
Participants will be included in this study for 1 week
2019-07-15
Participant Flow
Participant milestones
| Measure |
Crohn's Disease Patients
Patients with a diagnosis of Crohn's disease fitting the studies inclusion \& exclusion criteria.
|
Healthy Volunteers
For healthy volunteers the studies exclusion criteria apply.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Crohn's Disease Patients
n=30 Participants
Patients with a diagnosis of Crohn's disease fitting the studies inclusion \& exclusion criteria.
|
Healthy Volunteers
n=31 Participants
For healthy volunteers the studies exclusion criteria apply.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=30 Participants
|
31 Participants
n=31 Participants
|
60 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=61 Participants
|
|
Age, Continuous
|
32.3 years
n=30 Participants
|
32.8 years
n=31 Participants
|
32.5 years
n=61 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=30 Participants
|
12 Participants
n=31 Participants
|
24 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=30 Participants
|
19 Participants
n=31 Participants
|
37 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=30 Participants
|
31 participants
n=31 Participants
|
61 participants
n=61 Participants
|
PRIMARY outcome
Timeframe: Participants will be included in this study for 1 weekThe primary endpoints for this study will be food intake as measured by one telephone-administered 24-h dietary recall. Total calorific intake will be calculated.
Outcome measures
| Measure |
Crohn's Disease Patients
n=30 Participants
Patients with a diagnosis of Crohn's disease fitting the studies inclusion \& exclusion criteria.
|
Healthy Volunteers
n=31 Participants
For healthy volunteers the studies exclusion criteria apply.
|
|---|---|---|
|
Dietary Recalls (Calorific Intake)
|
1900.9 kcal
Standard Error 138.6
|
2054.3 kcal
Standard Error 110.7
|
SECONDARY outcome
Timeframe: Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.The TFEQ contains 51 items and measures three dimensions of human eating behaviour: Cognitive Restraint of Eating \[I\], Disinhibition \[II\], and Hunger \[III\]. Each item scores either 0 or 1 point. The minimum score for factors I, II. and III is therefore 0, with the pos- sible maximum scores being 21, 16, and 14 respectively. High scores mean worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.The BES is a 16-item questionnaire that assesses the severity of binge eating tendencies. Eight questions describe the behavioural mani- festations of binge eating behaviour and eight describe the feelings and cognitions associated with binge eating. Scores are summed to produce a total score ranging from 0 to 46. Cut-off points have previously been reported denoting mild \[≤17\], moderate \[18-26\], and severe \[≥27\] binge eating behaviours. High score means worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.The PFS is a 15-item questionnaire reflecting the psychological influence of the food environment. It measures appetite for, rather than consumption of, palatable foods and may be a useful measure of the hedonic impact of food environments replete with highly palatable foods. Items are grouped into three domains according to food proximity; food available but not physically present; food present but not tasted; and food tasted but not consumed. High scores mean worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.The 33-item DEBQ assesses different eating styles that may contribute to weight gain: emotional eating, external eating, and restraint. 'Emotional eating' occurs in response to emotional arousal states such as fear, anger, or anxiety; 'external eating' occurs in response to external food cues such as sight and smell of food; and 'restraint eating' is overeating after a period of slimming when the cognitive resolve to diet is abandoned. High score means worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.The CoEQ is a 21-item questionnaire designed to assess the severity and type of food cravings experienced over the previous 7 days. The CoEQ has four subscales: Craving Control, Craving for Savoury, Craving for Sweet, and Positive Mood. Items on the CoEQ are assessed by 100-mm visual analogue scales \[VAS\], with items relating to each subscale being averaged to create a final score. High positive mood is better outcome
Outcome measures
Outcome data not reported
Adverse Events
Crohn's Disease Patients
Healthy Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place