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临床试验/NCT06245369
NCT06245369已完成不适用

Self-monitoring with Internet Technology to Choose Healthy Diets Study

University of South Carolina2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年4月15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
106
试验地点
2
主要终点
Change in Healthy Eating Index

研究概览

简要总结

The goal of the Self-monitoring With Internet Technology to Choose Healthy Diets (SWITCH) study is to examine a 12-week remotely delivered program designed to help adults adopt a healthy dietary lifestyle and lose weight in a diverse cohort of adults with overweight/obesity.

The intervention uses a self-determination theory framework to provide a deeper understanding of the factors that influence dietary behavior within the context of tracking. This study incorporates autonomy-supportive strategies to encourage participants to feel more in control of their dietary choices and will provide information and resources to boost participant's competence in achieving their dietary goals. The intervention includes weekly learning modules to support healthy eating and weight loss and daily dietary tracking with visual feedback, all accessible within the SWITCH app.

详细描述

The SWITCH study is a 12-week remotely delivered, randomized behavioral intervention. Participants will be randomized to one of two groups: 1) SWITCH tracking nutrients to decrease (n=50) or 2) SWITCH tracking nutrients to increase (n=50). Participants will attend a study orientation, complete all baseline measures, be randomized, and then attend a training session for their group. In addition, participants will complete assessment at baseline and 12 weeks.

Intervention Design:

Diet tracking. Participants in both groups will be asked to track all meals, snacks, and beverages via the SWITCH app and complete a weekly learning module. Both groups will receive the same intervention, but the targeted nutrient goals and the in-app display of daily intake will differ between groups. Participants will be given goals to either increase certain nutrients or to decrease certain nutrients.

Diet related education to support healthy eating and weight loss will be provided each week within the SWITCH app. Each module includes some or all (as applicable) of the following components: A brief educational video discussing the week's topic, a video sharing ideas for applying the educational content into daily life, "meal swap" examples, a weekly goal or challenge and example recipes.

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
Double (Participant, Outcomes Assessor)

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

入选标准

  • Age between 18 and 64 years.
  • BMI between 25 - 49.9 kg/m2
  • Have 2 risk factors for T2DM in addition to having overweight or obesity (as defined by the NIDDK).
  • Own and use a smartphone with a data plan.
  • Must be willing and able to change dietary intake.
  • Be free of major health or psychiatric diseases, drug, or alcohol dependency.
  • Willing to sign informed consent.
  • Own a digital body weight scale, have regular access, or be willing to purchase one

排除标准

  • Currently participating in a weight loss program
  • Has lost more than 10 pounds in the past 6 months.
  • Diagnosed with type 2 diabetes or currently using medications that may impact blood glucose.
  • Pregnant (or have been pregnant in the last 6 months), anticipating becoming pregnant in the next 12 months, or currently breastfeeding.
  • Having an eating disorder.

结局指标

主要结局

Change in Healthy Eating Index

时间窗: 12 weeks

Change in Healthy Eating Index from baseline to 12 weeks as assessed by dietary recalls.

次要结局

  • Change in Body weight(12 weeks)

研究者

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

Brie Turner-McGrievy

Professor

University of South Carolina

研究点 (2)

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