Impact of Nutrition Counseling on the Nutritional Status of Patients with Ulcerative Colitis: a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- nutritional status
Study Overview
Brief Summary
randomized clinical trial aimed to find whether, In ulcerative colitis patients, nutrition counseling is associated with improved nutritional status.
objectives:
- Asses the nutritional status and quality of life among a sample of UC patients attending the NHTMRI outpatient clinic.
- Provide nutritional counseling for the randomly allocated intervention group
- Evaluate the effect of the nutritional counseling on nutritional status, quality of life and disease progression.
- Inclusion criteria: patients with moderate Ulcerative Colitis, in active phase. Adults aged 18-60, of both sexes
Patients in the intervention group will receive a counseling session then instructs on the subsequent follow up dates. Each patient of the intervention group is scheduled to receive weekly session, according to settled appointments; while the control arm will receive the regular service at the clinic.
Detailed Description
Administrative and Preparatory Phase:
After obtaining approval from the corresponding parties, a booklet in Arabic language with educational material and instruction will be prepared. Common foods for and against bowel discomfort will be emphasized. Dietary records will be included to check the adherence of the patients to the instructions.
II- Pre-intervention phase (The initial assessment):
The investigator will review the medical record of each patient to confirm the diagnosis and severity; then eligible patients in both counseling arm and the control arm will be interviewed by the investigator using a structured questionnaire to gather the following data for the initial assessment Personal and socio-demographic data: Comprised enquiry about each patient's age, sex, marital status, occupation, education, residency and telephone/mobile number.
b. Assessment of the quality of life using the short inflammatory bowel disease questionnaire (SIBDQ). It is a set of generic, coherent, and easily administered quality of life measures. Scores are from 0 to 10. A higher score indicates better health.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with moderate Ulcerative Colitis, in active phase.
- •Adults aged 18-60, of both sexes
Exclusion Criteria
- •Patients with acute fulminant colitis.
- •Patient with weight loss > 5% in the last month, and >10% weight loss in the last 6 months.
Arms & Interventions
intervention group
Patients with moderate Ulcerative Colitis, in active phase, Ages: Adults aged 18-60, of both sexes. Intervention: will receive nutritional counseling sessions ,nd weekly follow-up through clinic vists and mobile phones and messaging
Intervention: nutritional counseling (Behavioral)
control group
Patients with moderate Ulcerative Colitis, in active phase. Adults aged 18-60, of both sexes.
will receive regular care of the clinic.
Outcomes
Primary Outcomes
nutritional status
Time Frame: three months
weight in kilograms ,
dietary habits
Time Frame: three months
Dietary habits questionnaire to asses the cooking methods and daily habits.
quality of life score
Time Frame: three months
asses the QoL through the Short Inflammatory Bowel Disease Questionnaire SIBDQ score. It consists of 10 questions. Each question is scored by a 7-point Likert scale, ranging from 1 (a severe problem) to 7 (not a problem at all), giving an absolute SIBDQ score ranging from 10 (poor health related quality of life "HRQoL") to 70 (optimal HRQoL).
Secondary Outcomes
No secondary outcomes reported
Investigators
Rahma Mohammed Medhat Ali
assistant lecturer
Cairo University