A Novel Personalised NUtrition Intervention With Tailored Behavioural Support to Promote Sustainable and Healthy Diets in University Students: the P-NUTS Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Legume intake (g/d)
研究概览
简要总结
The aim of this study is to test the efficacy of a novel personalised nutrition intervention with tailored behavioural support compared to a control personalised nutrition intervention for improving adherence to sustainable and healthy dietary recommendations in young (18-30 years), healthy university students.
详细描述
Recruitment:
Participants will be recruited from the University College Dublin (UCD) PLAN'EAT Living Lab (LL) Citizen Panel (https://clinicaltrials.gov/study/NCT06939231), as well as from the wider eligible UCD university population. Eligible participants will be invited to participate in a 4-week study.
Power analysis:
The trial was powered for the group main effect in an analysis of covariance (ANCOVA) of the endpoint primary outcome variable adjusted for the baseline value of the primary outcome variable. Using G*Power 3.1 (F tests → ANCOVA: fixed effects, main effects and interactions), we set α = 0.05, power = 0.80, numerator df = 1, number of groups = 2, and number of covariates = 1. The effect size was taken from the primary outcome of the pilot trial (legume intake, g/d): partial eta squared (η²p) = 0.134, converted to Cohen's f, using the formula:
f = √η²p/(1- η²p)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a UCD student attending Belfield Campus.
- •Be an adult between the age of 18-30 years old, and in good general health.
排除标准
- •Do not attend UCD Belfield Campus.
- •Are <18 or >30 years of age.
- •Have a diagnosis of an acute or chronic medical condition that could interfere with the outcomes of the study. Such diagnoses include (but are not limited to) cardiovascular disease, diabetes mellitus, cancers (within the past 5 years), etc.
- •Are pregnant, lactating or planning to become pregnant.
- •Are following a medically prescribed diet.
- •Are immunocompromised or have a suspected immunodeficiency.
- •Have a known food allergy.
研究组 & 干预措施
Personalised sustainable/healthy dietary recommendations with standardised and tailored support
Intervention arm.
干预措施: Personalised sustainable and healthy dietary recommendations with standardised and tailored behavioural support. (Behavioral)
Personalised sustainable/healthy dietary recommendations with standardised support
Control arm.
干预措施: Personalised sustainable and healthy dietary recommendations with standardised behavioural support. (Behavioral)
结局指标
主要结局
Legume intake (g/d)
时间窗: 4 weeks
Legume intake (g/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If \<2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol). The primary outcome measure is endpoint legume intake (g/d). The primary estimand is the mean difference in legume intake (g/d) between groups at endpoint (4 weeks), adjusted for baseline legume intake (g/d). An exploratory analysis will be conducted to measure change in legume intake (g/d) between-groups at follow-up (8 weeks). The exploratory estimand will be the group × time interaction from a LMM at follow-up (8 weeks), and a between-group post-hoc test will be conducted where the group x time interaction is significant.
次要结局
- Total fruit and vegetable intake (g/d)(4 weeks)
- Total meat intake (g/d)(4 weeks)
- Total discretionary food intake (g/d)(4 weeks)
- Composite dietary behaviour index (CDBI) (z-score units)(4 weeks)