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临床试验/NCT04197063
NCT04197063已完成不适用

Evaluating a Portion Cap Policy on Sugar-Sweetened Beverages

Rutgers, The State University of New Jersey0 个研究点目标入组 359 人开始时间: 2015年1月14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
359
主要终点
Total calories food and beverages ordered from the study restaurant menu at the test dinner meal

研究概览

简要总结

This present study is an evaluation of de-identified data collected previously during a randomized controlled study (RCT). The objective of the original RCT titled "Sugar-Sweetened Beverage (SSB) Portion Limit Dining Lab RCT" was to examine the impact of limiting the portion size of SSB to 16 oz in a laboratory dining setting. The RCT was designed to assess the impact of limiting the size of SSB offered on a restaurant menu and the availability of free fills on beverage and food purchases, consumption and caloric intake at the test meal and subsequent meals (over a 24-hour period).

详细描述

Briefly, the data for this evaluation were collected from adults recruited from the Boston / Cambridge area to participate in an RCT conducted at an eating behavior lab at the Landmark Center (Lab). Participants were masked to the purpose of the study and were randomized to one of four conditions. To conceal the purpose of the study, participants were asked to participate in a pseudo-focus group pretending to conduct consumer research on restaurant preferences. Participants were asked not to eat after 3 pm prior to the 5:30 pm focus group. Participants were seated at individual dining tables and were asked to order and purchase dinner from a restaurant menu and consumed the meal while in the restaurant Lab. After the focus group, participants completed electronic questionnaires (e.g., demographic information, eating behaviors, and perceptions of the meal). Participants returned to the Lab the following day to complete a brief dietary recall interview. After they completed the study procedures, they were debriefed about the purpose of the study and provided the opportunity to withdraw from the study.

The current evaluation will be conducted under an IRB-approved, apriori, statistical analysis plan using the data collected during the Sugar-Sweetened Beverage (SSB) Portion limit Dining Lab RCT.

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
Single (Participant)

盲法说明

The data was collected during a sham focus group where the purpose of the study was concealed from the participants. The purpose of the study was unmasked to participants when they returned on the following day and completed the study.

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 18 years and older
  • Ability to speak and read English
  • Willing to participate and follow protocol specified activities

排除标准

  • Severe food allergies

结局指标

主要结局

Total calories food and beverages ordered from the study restaurant menu at the test dinner meal

时间窗: Immediately after Day 1 test dinner meal

Total calories ordered will be computed by summing the calories of each menu item selected for the test dinner meal. The calorie content for all food and drinks will be based on the nutritional information, posted on the restaurant's website for each menu item.

Total calories from food and drink consumed during the test the dinner meal

时间窗: 24-hours post-Day 1 test dinner meal

Calories consumed will be measured by weighing all food items before and after the test dinner meal using a digital scale accurate up to +0.1 grams. The weight of each plate/cup collected after the meal will be subtracted from the weight of each plate/cup prior to being served. The weight of the food in conjunction with the caloric density of each item will be combined to calculate the total caloric intake for each participant at the test dinner meal.

次要结局

  • Total food calories ordered at the dinner meal(Immediately after Day 1 test dinner meal)
  • Total calories consumed after the dinner meal(24-hours post-Day 1 test dinner meal)
  • Total food calories consumed at the dinner meal(Immediately after Day 1 test dinner meal)
  • Combination of calories consumed at dinner & post-dinner(From immediately after Day 1 test dinner meal until 24-hours post Day 1 dinner meal)
  • Total beverage calories ordered at the dinner meal(Immediately after Day 1 test dinner meal)
  • Total beverage calories consumed at the dinner meal(Immediately after Day 1 test dinner meal)

研究者

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

Pamela Rothpletz-Puglia, EdD, RD

Associate Professor

Rutgers, The State University of New Jersey

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