Completed
NCT Number: NCT04197063
Sugar-Sweetened Beverage Portion Limit Study
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).
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adults 18 years and older
- Ability to speak and read English
- Willing to participate and follow protocol specified activities
Exclusion criteria
-Severe food allergies
Treatment and study plan
Primary outcomes
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Total calories food and beverages ordered from the study restaurant menu at the test dinner meal
Time frame: 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.
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Total calories from food and drink consumed during the test the dinner meal
Time frame: 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.
Secondary outcomes
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Total beverage calories ordered at the dinner meal
Time frame: Immediately after Day 1 test dinner meal
The beverages calorie content of beverage items was based on the nutritional information available online.
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Total beverage calories consumed at the dinner meal
Time frame: Immediately after Day 1 test dinner meal
Beverages were weighed before and after the meal to allow for the calculation of total beverage calories consumed. The calorie content of the beverage items was based on the nutritional information available online.
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Total food calories ordered at the dinner meal
Time frame: Immediately after Day 1 test dinner meal
The food calorie content was based on the nutritional information available online.
-
Total food calories consumed at the dinner meal
Time frame: Immediately after Day 1 test dinner meal
Food items were weighed before and after the meal to allow for the calculation of total calories consumed. The calorie content of food items was based on the nutritional information available online.
-
Total calories consumed after the dinner meal
Time frame: 24-hours post-Day 1 test dinner meal
Total calories participants consumed after the dinner meal were measured with the National Cancer Institute's web-based Automated Self Administered 24-hour Dietary Recall program
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Combination of calories consumed at dinner & post-dinner
Time frame: From immediately after Day 1 test dinner meal until 24-hours post Day 1 dinner meal
This will be calculated by adding the value for total calories consumed at the dinner meal to the value for total calories consumed post-dinner.
Other outcomes
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Overall satisfaction with the price of the food item/s ordered: 7-point Likert item
Time frame: Immediately after Day 1 test dinner meal
7-point Likert item (1= not at all satisfied; 7= extremely satisfied]
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Overall satisfaction with the portion of the food item/s ordered: 7-point Likert item
Time frame: Immediately after Day 1 test dinner meal
7-point Likert item (1= not at all satisfied; 7= extremely satisfied]
-
Satisfaction with drink size
Time frame: Immediately after Day 1 test dinner meal
Too small, Just right, Too big
-
Pre-meal hunger
Time frame: Immediately after Day 1 test dinner meal
Before eating this meal, how hungry were you? [7-point Likert item (1= not at all hungry, 7= extremely hungry)]
Sponsors and collaborators
Lead sponsor
Rutgers, The State University of New Jersey
Other
Registry information
Official study title
Evaluating a Portion Cap Policy on Sugar-Sweetened Beverages
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Dec 12, 2019
- Registry last updated
- Feb 7, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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