Evaluating a Portion Cap Policy on Sugar-Sweetened Beverages
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 359
- Primary Endpoint
- Total calories food and beverages ordered from the study restaurant menu at the test dinner meal
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
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
- 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)
Investigators
Pamela Rothpletz-Puglia, EdD, RD
Associate Professor
Rutgers, The State University of New Jersey