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临床试验/NCT04513769
NCT04513769已完成不适用

Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation

University of South Carolina1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
body weight

研究概览

简要总结

To date, few dissemination and implementation (D&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims:

Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through a train-the-trainer approach in a soul food vegan restaurant.

Aim 2: Assess resource use and cost associated with a train-the-trainer D&I approach in a restaurant setting.

Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight loss, and quality of life from baseline to follow-up (3-months) and at maintenance (9-months).

Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •self-identify as African American
  • •between 18-65 years old
  • •be free on meeting night (Tuesday at 6PM)
  • •be free of eating disorder
  • •be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
  • •willing to travel weekly to Rare Variety Café

排除标准

  • •currently following a plant-based/vegan diet
  • •have a body mass index of under 25 or over 49.9 kg/m2
  • •currently on medication for diabetes
  • •women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
  • •currently participating in a weight loss program or taking weight loss medications
  • •recent weight loss (>10lbs in the last 6 months)
  • •living in the same household as somebody already participating in the larger NEW Soul Study at the University of South Carolina
  • •currently in the NEW Soul study

研究组 & 干预措施

Study participants

Experimental

This is a single-arm study so all participants receive the same intervention.

干预措施: Vegan diet (Behavioral)

结局指标

主要结局

body weight

时间窗: 0, 3, and 12 months

Assess changes in body weight

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Bernhart

Principal Investigator

University of South Carolina

研究点 (1)

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