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临床试验/NCT01837524
NCT01837524已完成不适用

The KP Personal Shopper: A Pilot to Improve the Impact of Dietary Advice

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).

研究概览

简要总结

Randomized trial of grocery-store based nutrition counseling visits for weight management vs. in-office visits. The investigators will test pre- and post-intervention individual-level dietary quality, knowledge, self-efficacy around dietary choice, and cost of shopping, measuring difference between intervention and control arms. At the study's end, the investigators will also conduct focus groups with a subset of 20 patients (10 from each arm) and do a structured interview with the dietitian to better understand the feasibility, strengths and shortcomings of this approach. Patients who complete the main portion of the trial will be randomly selected for recruitment into a focus group and consented separately for that focus group at the end of the study.

The investigators hypothesize that, compared to office-based visits, the KP Personal Shopper visits will result in higher member diet quality scores, better nutritional knowledge scores, higher self-efficacy and confidence around food purchasing decisions, and more favorable perception of the visit by both dietician and member. The KP Personal Shopper approach may also result in increased grocery store costs for some members. Long-term, the investigators hypothesize that improvements in member perception, knowledge and dietary quality will lead to improved health outcomes.

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
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Employee population of a specific Southeastern U.S. County
  • 18-64 years of age
  • Body Mass Index greater than or equal to 30kg/m^2 (Obese)
  • Low rate of no-shows for office visits (<10%)
  • Saw PCP or other provider in past 12 months
  • Does at least 50% of the food shopping and/or food preparation for their household

排除标准

  • non-English speaking
  • Currently being treated for cancer (other than non-melanoma skin cancer)
  • Pregnant or planning pregnancy in the next 6 months
  • Had or considering having bariatric surgery
  • Currently participating in commercial weight loss program (e.g. Jenny Craig)
  • Currently enrolled in another weight management or nutrition study

结局指标

主要结局

Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).

时间窗: 3 months

The Block FFQ will be administered at baseline in order to calculate a participant's baseline HEI score, and will be re-administered after the 3 month intervention to re-calculate the post-intervention HEI score. The numbers reported here represent the change from pre to post intervention, in the HEI scores for participants in each group HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet. There are no units associated with the HEI score. The measure was developed by the US Dept of Agriculture and complete details regarding its development can be found on their website.

次要结局

  • Nutritional Knowledge of Members(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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