Effect of Fruit Smoothie Supplementation on Psychological Distress Among People With Substance Use Disorders Receiving Opioid Agonist Therapy: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Psychological distress
研究概览
简要总结
Background: People with substance use disorders generally have poor diets including limited intake of fruit and vegetables. Evidence shows substantial health benefits from increasing fruit and vegetable consumption on a variety of indicators and possibly also psychological distress. A pilot study has indicated that supplementation with fruit smoothie could be promising also among people receiving opioid agonist therapy (OAT) for opioid dependence. FruktBAR will compare the efficacy of fruit smoothie supplementation within the OAT clinics compared to standard treatment.
Study design: FruktBAR is a multicentre, randomised controlled trial. The trial will recruit approximately 230 patients receiving OAT in Bergen and Stavanger, Norway.
Intervention: The intervention involves daily supplementation with 250 ml fruit smoothie. The main endpoints are 16 weeks after intervention initiation. Participants will be included and followed up during and after intervention.
Study population: The target group will be patients with opioid dependence receiving OAT from involved outpatient clinics in Bergen and Stavanger.
Expected outcome: This study will inform on the relative advantages or disadvantages of a fruit supplementation in addition to the current medically and psychologically oriented treatment of people receiving opioid agonist therapy. If the supplementation is found to be safe and efficacious, it can be considered for further scale-up.
详细描述
See below each section
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Even though complete blinding is regarded as difficult and infeasible, patients will be informed of the follow-up they will receive but not on other follow-up alternatives that are used or the exact hypotheses for the study. Outcomes assessor will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving OAT from an included outpatient clinic with outpatient follow-up on weekly basis
- •Having fruit and vegetable intake below 3 portions per day (assessed at screening)
- •Confirming interest in participating in diet intervention (criteria specified)
- •Giving informed consent
排除标准
- •Allergies or prior anaphylactic reactions involving fruits or vegetables
- •Poorly regulated diabetes type 1 or 2 (HbA1c >60 mmol/mol)
研究组 & 干预措施
Fruit smoothie
Participants randomised to the intervention arm will receive a 250 ml fruit smoothie as diet supplement for 20 weeks in addition to the regular OAT clinic follow-up. The fruit smoothies will be marketed products including combinations of the following fruits: apple, pineapple, mango, bananas, orange, blueberries, passion fruit, coconut, lime, and blackcurrant. The participants will receive a mixture of different smoothie types with the option of removing alternatives based on preferences. Fruit smoothie products will come in plastic bottles and will be delivered directly to the participants on a weekly basis. Each participant will receive a total of seven smoothie bottles per week with an oral agreement with each participant to consume one of these per day. Delivery of fruit smoothie will generally be given in parallel with delivery of OAT medication.
干预措施: Fruit smoothie (Dietary Supplement)
Standard
Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation.
结局指标
主要结局
Psychological distress
时间窗: Mid of the intervention period 16 weeks after initiation
The primary outcome is psychological distress assessed with the Norwegian validated translation ten item version of Hopkins Symptom Checklist (SCL-10) in the mid of the intervention period 16 weeks after initiation (12-20). This will be evaluated with mean SCL-10 item score and compared between intervention and control arm.
次要结局
- Biochemical indicators of fruit intake(Mid of the intervention period 16 weeks after initiation)
- Fatigue Symptom Scale(Mid of the intervention period 16 weeks after initiation)
- Biochemical indicator of inflammation(Mid of the intervention period 16 weeks after initiation)
- Physical functioning(Mid of the intervention period 16 weeks after initiation)
- Health-related quality of life(Mid of the intervention period 16 weeks after initiation)