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临床试验/NCT05049005
NCT05049005已完成不适用

Dietary Approaches for Improving Engagement, Diet Quality, and Weight Loss in Young Adults

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月4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
60
试验地点
2
主要终点
Adherence to dietary goals

研究概览

简要总结

Purpose: Compare the efficacy of two 3-month Internet-based interventions that use a simplified strategy for monitoring of dietary intake among young adult men and women with overweight or obesity.

Participants: Young adult men and women who are between the ages of 18-35 years (N=75) and who currently have overweight or obesity (BMI between 25 and 50 kg/m^2).

Procedures (methods): This is a randomized controlled trial comparing the efficacy of two Internet-based dietary interventions among 75 young adult men and women who currently have overweight or obesity. Both interventions will use simplified monitoring of dietary intake using an approach based on the Traffic Light Diet. One intervention will target a reduction in intake of red foods (high-calorie, high-fat foods) and tracking of red foods in the study website. The other intervention will target an increase in intake of green foods (low-calorie, healthy foods) and tracking of green foods in the study website. Components of both interventions include (1) personalized goals for red/green food intake, (2) weekly tailored feedback, and (3) weekly lessons delivered via smartphone.

详细描述

The primary objective of the study is to test two approaches for dietary self-monitoring among young adults with overweight/obesity. Thus, all participants will receive an Internet-based dietary intervention that includes evidence-based lessons focused on dietary change, behavioral skills training, and frequent weighing. The only difference between the two groups will be the types of foods participants are instructed to self-monitor and the dietary goals participants are given. Young adult men and women (N=75) will be randomly assigned, with equal probability, to one of two groups:

  1. Red food reduction intervention (RED FOOD): An Internet-based dietary intervention delivered via REDCap; weekly self-report of weight and daily red food monitoring using a mobile-optimized study website.
  2. Green food promotion intervention (GREEN FOOD): An Internet-based dietary intervention delivered via REDCap; weekly self-report of weight and daily green food monitoring using a mobile-optimized study website.

During the 3-month Internet-based dietary intervention, participants will receive an email at the beginning of each week with a link to a REDCap page that will ask them to self-report their weight. They will then be directed via REDCap to their tailored feedback summaries based on their self-reported weight data and the dietary monitoring data that is pulled from the study website. After reading their feedback, participants will be directed to a weekly lesson in REDCap. Participants will be encouraged to login to the study website every day to self-monitor red or green foods, depending on their intervention group. Participants will receive a unique username and password to login to the study website. Each intervention component is described in more detail below.

Intervention Components:

Participant goals: Participants will be assigned a dietary goal based on their baseline weight. Participants will be able to view their daily dietary goal (number of red foods per day in RED FOOD and number of green foods per day in GREEN FOOD) on the study website. Participants' dietary goals will be based on their intervention group. Participants will not receive specific goals for weighing or physical activity. However, all participants will be recommended to weigh frequently throughout the week, as research has shown this is best for successful weight loss. Participants will self-report their weight online via REDCap once per week.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body Mass Index (BMI) between 25 and 50 kg/m^2
  • English-speaking and writing
  • Own a smartphone with an active data and text messaging plan
  • Own a bathroom scale or willing to purchase a bathroom scale prior to the study start date
  • Willing to be randomized to either group

排除标准

  • Type I or Type 2 diabetes
  • Currently participating in another nutrition or weight loss program
  • Lost 10 or more pounds (and kept it off) in the last 6 months
  • Currently taking weight loss medications
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant in the next 6 months
  • Serious current physical disease (i.e. heart disease, stroke, cancer, or renal disease) for which physician supervision of diet and exercise prescription is needed
  • Physical problems that limit the ability to exercise daily
  • History of clinically diagnosed eating disorder
  • Report a past diagnosis of or current symptoms of alcohol or substance dependence
  • Diagnosis of schizophrenia or bipolar disorder
  • Hospitalization for a psychiatric diagnosis within the last year
  • Currently living with another study participant

结局指标

主要结局

Adherence to dietary goals

时间窗: 3 months

Adherence will be measured as the total number of full days of tracking (i.e. breakfast or lunch AND dinner) during which participants met their dietary goal. Non-adherence will be assumed for partial days of tracking, or days where participants did not track.

Adherence to dietary tracking

时间窗: 3 months

Adherence will be assessed via frequency of dietary monitoring. Each food entry will be time-stamped and automatically captured by the study website interface. Frequency of dietary monitoring will be defined as the total number of days during the 3-month intervention that participants tracked breakfast or lunch AND dinner, which will be considered a full (versus partial) day of tracking.

次要结局

  • Change in Diet quality(Baseline, Month 3)
  • Percent weight loss(3 months)
  • Change in Dietary intake(Baseline, Month 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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