Chain restaurants were eligible for inclusion in the study if they were ranked among the top 50 quick-service restaurants in 2010 (10), served entrées (were not coffee shops), and met criteria regarding location and data availability. Restaurant selection aimed to include large restaurant chains, given their larger contribution to Americans’ diets as compared with smaller chains. By using the Top-50 QSR (quick service restaurant) ranking (10), restaurants were considered for inclusion beginning with 1 and moving to 50. Location criteria were that the restaurant chain company had 20 or more locations nationally, that case restaurant chains had outlets in areas where menu-labeling regulations had been implemented before 2011, and that control restaurant chains did not have outlets in jurisdictions requiring menu labeling. Data criteria were that the restaurant chain’s website posted nutrition information for 6 or more years of the study period, that nutrition values were listed for 90% or more of menu items, and that values for calories, saturated fat, and sodium were provided (cholesterol and fiber were also provided by the eligible restaurants, so we were able to include them in the analysis). Few chain restaurants consistently posted complete nutrition data during the study period. Only 9 restaurant chains met study criteria and were included (Table 1). For purposes of this article, the 9 restaurant chains included in our study were de-identified and assigned a letter, A through I.

Historic data came from an archive of Internet data collected from publicly accessible Web pages beginning in 1996 (11). The archive shows chain restaurant company websites exactly as they appeared in previous years. Dates were printed on each Internet menu; thus, we were able to verify the year the nutritional information represented. When possible, menus were collected from June of each calendar year.

We analyzed sections of the menu with the most food items: à la carte adult entrées, adult side dishes, and à la carte children’s entrées. Adult entrées and sides (including breakfast items) were identified on the basis of their respective menu section headers, and menu sections that were not consistently included in restaurant nutrition data (desserts, beverages, and condiments) were excluded. To reduce the subjective nature of the classification, we retained items listed on the menu as entrées even if they represented less than what would typically be purchased as an entrée (eg, 1 chicken wing). Children’s menu items were identified using the menu section header when available or if the item name contained the words “child” or “kid.” Combination items including an entréeand side were excluded, as were items that specified “family” in the item name (eg, popcorn chicken – family size). Nutrient analysis was limited to calories, cholesterol, fiber, saturated fat, and sodium. Although the majority of existing regulations solely require the posting of calorie information, our analysis included additional nutrients in order to broadly characterize the nutritional quality of fast-food menus and to assess key nutrients of concern in the American diet.

Restaurants varied in the number of menu items listed annually. To avoid skewing results toward restaurants with numerous items, we calculated the annual mean for each of the 5 nutrition values by restaurant and used that mean to generate annual means for the case and control restaurants. Three menu years were unavailable (Restaurant H, 2009; Restaurant B, 2005; Restaurant I, 2005) and thus were interpolated linearly from available data for each of the restaurants.

To determine if restaurant chains altered the proportion of “healthier” menu items, we designated offerings as healthier by using criteria based on Dietary Reference Values (DRV) for a 2000-calorie diet (12), the US Food and Drug Administration standards for packaged food labels (13), and the Dietary Guidelines for Americans (12). There are no federal guidelines for appropriate nutrient levels for adult à la carte restaurant menu items; thus, we selected less than or equal to 25% of the DRV as the criterion for healthier à la carte entrées and less than or equal to 10% of the DRV as the criterion for healthier adult side dishes (Table 2). Some recently published studies used one-third of daily values as a benchmark (9,14) but did not distinguish entrées with and without side dishes. We used one-fourth of daily values because we limited fast-food entrées to those without side dishes (à la carte, not full meals) and because research has shown that most fast-food customers order 2 food items (3). A summary indicator flagged adult menu items that met 4 of 5 nutritional criteria. We originally restricted this indicator to 5 of 5 criteria. However, no menu items satisfied all 5 nutrient criteria, so we relaxed the definition to 4 of 5. Subsequently, we calculated the annual proportion of healthier items for à la carte entrées and sides for each of the 9 restaurants and then aggregated the information for case restaurants and control restaurants.

During the study period, 7 of the 9 restaurants listed children’s menus (Table 1). The number of menu items by year and restaurant was small, precluding examination at the restaurant level. Thus, we analyzed children’s menu items by pooling all children's items for the case restaurants and pooling all children’s items for the control restaurants. We based the criteria for children’s menu items on the DRVs for a 1,400-calorie diet, which represents typical calorie needs for sedentary to moderately active children aged 8 years, depending on sex and body size (13); the same criteria have been used by others (6). The US Department of Agriculture, through its school meal programs, has guidelines for calories, fat, and sodium content for children’s meals. However, it does not have standards for each component of a menu. Thus, we applied the following criteria: children’s à la carte entrées were categorized as healthier, as we defined the term, if they were 25% or less of the DRV. Because few children’s items met the “healthier” criteria for fiber or sodium, we used 2 summary indicators, 1 indicator for 3 or more of the 5 nutritional criteria for children’s items and another indicator for 4 or more.

Descriptive analyses were performed on annual means for all nutritional values at the case and control restaurants, annual proportions of healthier menu items, and the case and control differences between first and last year of observed data. Analyses examined each nutrient for items displayed on 9 restaurant menus over 7 years. We estimated case versus control restaurant differences in trends over time for mean nutritional values and proportion of healthier menu items by using the MIXED procedure in SAS version 9.2 (SAS Institute Inc., Cary, North Carolina). Extreme outliers were controlled for by restricting analyses to sections of the menu with the most food items and excluding entrées with sides and entrées that were combination meals. The data were approximately normally distributed, and means and medians approximated each other; therefore, means were reported. Regression models included all years of data, the number of restaurant entrées or sides dishes, and a random intercept for restaurant. The interaction between case status and an indicator variable for pre–post labeling regulation (before vs after 2008) tested whether the outcome variables differed by case status. This procedure was repeated for adult entrées, adult sides, and children’s entrées.

Throughout the study period, across all restaurants, the nutritional profile of fast-food menu items showed high levels of sodium and saturated fat coupled with low levels of fiber (Table 3). When values for an average à la carte entrée and a side dish were combined, they contained 70% and 60% of the daily limit of sodium and saturated fat, respectively. Adult à la carte entrées averaged 450 kcal, 85 mg cholesterol, 3 g fiber, 8 g saturated fat, and 1,100 mg sodium (approximately 2,400 mg sodium per 1,000 calories). Adult sides averaged 300 kcal and 640 mg sodium (or approximately 2,000 mg sodium per 1,000 calories) (Figure). When modeling differences in nutrient averages, regression models found no statistically significant changes over time in nutrient averages and no statistically significant differences between the nutritional averages of case and control restaurants (P ≥ .50). Case-by-case analyses highlighted the heterogeneity in restaurant trends (Table 3): 3 of 5 labeled restaurants improved their offerings, while 2 of 5 showed no improvement and even launched new options, such as bacon cheeseburgers, that increased average calories by almost 20% and cholesterol by almost 140%.

During the study period, the overall proportion of healthier adult entrées that met 4 or more of the nutritional guidelines remained less than 25%, with fiber and sodium least likely to meet healthier standards (Table 4). Control restaurants had a lower proportion of healthier items than cases, remaining at approximately 7% over the study period (Figure). In contrast, case restaurants increased the proportion of healthier entrées after labeling regulations: from 13% during years 2005 through 2008, up to 20% by 2011 (regression trend analysis found a mean difference of 5% pre–post 2008 in cases relative to controls: interaction, β = 5.1%; 95% confidence interval [CI], 0.9%–9.3%, P = .02). These improvements were largely attributed to Restaurant A (reduced saturated fat), Restaurant B (offered grilled alternatives to deep-fried entrées, and reduced calories and sodium) and Restaurant D (reduced calories). The prevalence of healthier side dishes was higher among case restaurants than controls (23% vs 15%, respectively) and did not change over time. Similar to entrées, sodium levels in sides were least likely to meet the healthier standard.

Average nutritional values for children’s à la carte entrées at case restaurants were 260 kcal and 690 mg sodium and at control restaurants, 430 kcal and 860 mg sodium. Pooled across all restaurants, children’s à la carte entrées averaged 37 mg cholesterol, 2 g fiber, and 5 g saturated fat. By using 4 or more of the 5 nutritional criteria to define healthier options, no control restaurants had qualifying items, and only 1 case restaurant had qualifying items (Restaurant E). When healthier options were defined as 3 or more out of the 5 nutritional criteria, the proportion of healthier children’s entrées at case restaurants was much higher than at control restaurants. However, no difference was observed in the trend over time: prevalence for meeting 3 of 5 criteria was around 60% for case restaurants and 10% for control restaurants (difference in prevalence, n = 22, P = .02; test for interaction in regression trend analysis, P = .60). Similar to adult menu items, fiber and sodium in children’s menu items were least likely to meet healthier criteria.