Sugar-Sweetened Beverage Portion Limit Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating a Portion Cap Policy on Sugar-Sweetened Beverages

Conditions
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Health Policy

Intervention / Treatment
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* Behavioral: Sweetened beverage portion size limit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study randomized participants to one of four conditions: 1) Current SSB restaurant portion sizes with the option to purchase beverage refills; 2) Current SSB restaurant portions plus free refills; 3) </= 16 oz. SSB portions with the option to purchase beverage refills; or 4) </= 16 oz. SSB portions plus free refills.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Current SSB restaurant portions purchase refill<br>Offered a menu with current SSB restaurant portion sizes with the option to purchase refills | Behavioral: Sweetened beverage portion size limit<br> <br> |
| Experimental: Current SSB restaurant portions free refill<br>Offered a menu with current SSB restaurant portion sizes plus free beverage refills | Behavioral: Sweetened beverage portion size limit<br> <br> |
| Experimental: </= 16 oz. SSB portions with the option to purchase refills<br>Offered a menu with </= 16 oz. SSB portion sizes with the option to purchase refills | Behavioral: Sweetened beverage portion size limit<br> <br> |
| Experimental: </= 16 oz. SSB portions plus free refills<br>Offered a menu with </= 16 oz. SSB portion sizes plus free refills | Behavioral: Sweetened beverage portion size limit<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total calories food and beverages ordered from the study restaurant menu at the 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. | Immediately after Day 1 test dinner meal | 
| Total calories from food and drink consumed during the test the 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. | 24-hours post-Day 1 test dinner meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total beverage calories ordered at the dinner meal | The beverages calorie content of beverage items was based on the nutritional information available online. | Immediately after Day 1 test dinner meal | 
| Total beverage calories consumed at the 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. | Immediately after Day 1 test dinner meal | 
| Total food calories ordered at the dinner meal | The food calorie content was based on the nutritional information available online. | Immediately after Day 1 test dinner meal | 
| Total food calories consumed at the 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. | Immediately after Day 1 test dinner meal | 
| Total calories consumed after the 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 | 24-hours post-Day 1 test dinner meal | 
| Combination of calories consumed at dinner & post-dinner | 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. | From immediately after Day 1 test dinner meal until 24-hours post Day 1 dinner meal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sweetened beverage, portion size, policy