Impact of Nutrition Counseling on the Nutritional Status of Patients with Ulcerative Colitis: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- nutritional status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate Ulcerative Colitis, in active phase.
- •Adults aged 18-60, of both sexes
排除标准
- •Patients with acute fulminant colitis.
- •Patient with weight loss > 5% in the last month, and >10% weight loss in the last 6 months.
研究组 & 干预措施
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
干预措施: 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.
结局指标
主要结局
nutritional status
时间窗: three months
weight in kilograms ,
dietary habits
时间窗: three months
Dietary habits questionnaire to asses the cooking methods and daily habits.
quality of life score
时间窗: 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).
次要结局
未报告次要终点
研究者
Rahma Mohammed Medhat Ali
assistant lecturer
Cairo University