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临床试验/NCT05166512
NCT05166512已完成不适用

Development and Pilot Evaluation of a Novel Cooking Skills Intervention to Prevent Diabetes

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Change From Baseline in Absolute Body Weight (Kilograms (kg))

研究概览

简要总结

In this pilot trial participants will be randomized 1:1 to participate in either standard Diabetes Prevention Program (DPP) vs. DPP plus a novel cooking skills intervention (DPP Cooks). The researchers hypothesize that participants randomized to DPP Cooks will have greater weight loss, better diet quality at 4 months, and greater confidence in their cooking skills and ability to implement dietary changes recommended in the DPP.

详细描述

This study is a randomized pilot trial testing a novel cooking skills intervention (DPP Cooks) vs. the standard Diabetes Prevention Program (DPP). The DPP is a widely disseminated evidenced-based lifestyle behavior change program to help adults with pre-diabetes lose weight and prevent type-2 diabetes. In this trial the investigators will test whether the addition of food-agency based cooking skills classes improves the effectiveness of the DPP. This trial will take place in Baltimore, MD in collaboration with community partner DPP providers. The trial has been informed by formative work with prior DPP participants and has used a Community Based Participatory Research (CBPR) approach to developing the DPP Cooks intervention. Participants will be randomized 1:1 to participate in either standard DPP vs. DPP Cooks. The length of the trial will be 12 months and outcomes will be measured at baseline, 4 months, and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Adults in Baltimore City
  • eligible for DPP based on Centers for Disease Control guidelines
  • possession of a smart phone with camera
  • can commit to 12 month study participation

排除标准

  • current or prior diagnosis of type 1- or type 2 diabetes
  • non-English speaker
  • participating in another research study that may effect diabetes, diet, or weight loss
  • currently pregnant

结局指标

主要结局

Change From Baseline in Absolute Body Weight (Kilograms (kg))

时间窗: baseline, 4 months and 12 months

Weight change will be measured in absolute kg. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings).

Change From Baseline in Percentage of Baseline Bodyweight

时间窗: baseline, 4 months and 12 months

Weight change will be measured in the percent of body weight change. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings).

次要结局

  • Difference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score(Baseline and at 4 months)
  • Change From Baseline in Cooking Confidence(baseline, 4 months and 12 months)
  • Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)(baseline, 4 months and 12 months)
  • Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module(baseline, 4 months and 12 months)
  • Change From Baseline in Cooking Attitudes(baseline, 4 months and 12 months)
  • Change From Baseline in Cooking Behavior (Days Cooking Dinner)(baseline, 4 months and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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