Design of the Building Research in CRC prevention (BRIDGE-CRC) trial: a 6-month, parallel group Mediterranean diet and weight loss randomized controlled lifestyle intervention targeting the bile acid-gut microbiome axis to reduce colorectal cancer risk among African American/Black adults with obesity.

BACKGROUND: Among all racial/ethnic groups, people who identify as African American/Blacks have the second highest colorectal cancer (CRC) incidence in the USA. This disparity may exist because African American/Blacks, compared to other racial/ethnic groups, have a higher prevalence of risk factors for CRC, including obesity, low fiber consumption, and higher intakes of fat and animal protein. One unexplored, underlying mechanism of this relationship is the bile acid-gut microbiome axis. High saturated fat, low fiber diets, and obesity lead to increases in tumor promoting secondary bile acids. Diets high in fiber, such as a Mediterranean diet, and intentional weight loss may reduce CRC risk by modulating the bile acid-gut microbiome axis. The purpose of this study is to test the impact of a Mediterranean diet alone, weight loss alone, or both, compared to typical diet controls on the bile acid-gut microbiome axis and CRC risk factors among African American/Blacks with obesity. Because weight loss or a Mediterranean diet alone can reduce CRC risk, we hypothesize that weight loss plus a Mediterranean diet will reduce CRC risk the most. METHODS: This randomized controlled lifestyle intervention will randomize 192 African American/Blacks with obesity, aged 45-75 years to one of four arms: Mediterranean diet, weight loss, weight loss plus Mediterranean diet, or typical diet controls, for 6 months (48 per arm). Data will be collected at baseline, mid-study, and study end. Primary outcomes include total circulating and fecal bile acids, taurine-conjugated bile acids, and deoxycholic acid. Secondary outcomes include body weight, body composition, dietary change, physical activity, metabolic risk, circulating cytokines, gut microbial community structure and composition, fecal short-chain fatty acids, and expression levels of genes from exfoliated intestinal cells linked to carcinogenesis. DISCUSSION: This study will be the first randomized controlled trial to examine the effects of a Mediterranean diet, weight loss, or both on bile acid metabolism, the gut microbiome, and intestinal epithelial genes associated with carcinogenesis. This approach to CRC risk reduction may be especially important among African American/Blacks given their higher risk factor profile and increased CRC incidence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04753359 . Registered on 15 February 2021.

Effect of Mediterranean diet and Mediterranean diet plus calorie restriction on cognition, lifestyle, and cardiometabolic health: A randomized clinical trial.

A Mediterranean diet and intentional weight loss each positively affect cognitive functioning. Combining both could produce synergistic effects on cognition. The purpose of this study is to compare a Mediterranean diet lifestyle intervention with and without caloric restriction versus control on cognition, lifestyle, and cardiometabolic disease. In a three-arm trial conducted between 2017 and 2020 in Chicago, one hundred and eight-five, 55-85-year-old, predominately non-Hispanic black females with obesity were randomized (2:2:1) to an 8-month Mediterranean diet plus caloric restriction intervention, Mediterranean diet alone, or control. The primary outcome was change from baseline to post-intervention in cognitive composite scores: attention, information & processing; executive function; and learning, memory, & recognition. Secondary outcomes were weight, lifestyle and cardiometabolic markers. The 8-month Mediterranean diet interventions did not significantly affect cognition. Adherence to a Mediterranean diet improved more in the Mediterranean diet plus caloric restriction arm (mean [SE] score change, +6.3 [0.7] points) and Mediterranean diet alone arm (+4.8 [0.7] points) relative to controls (+0.6 [0.9] points). Mean weight loss was greater among the Mediterranean diet plus caloric restriction arm (-4.6 [0.6] kg) compared to the Mediterranean diet alone (-2.6 [0.6] kg) and control arms (-0.6 [0.7] kg). The interventions did not affect activity or cardiometabolic risk markers; although, fasting insulin did decline in the Mediterranean diet plus caloric restriction arm relative to the Mediterranean diet alone and control arms. A Mediterranean diet lifestyle intervention with and without caloric restriction did not significantly affect cognitive function compared to controls. The Mediterranean diet interventions, however, significantly affected diet quality and body weight.

Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial.

BACKGROUND: The COVID-19 pandemic has altered the research landscape for clinical trials, requiring thoughtful consideration regarding how to handle the risks and benefits of continuing them. DESIGN: This brief report describes the experience of adapting the Building Research in Diet and Cognition (BRIDGE) study, a randomized clinical trial examining the effects of the Mediterranean diet, with and without weight loss, on cognitive functioning in 185 older obese African American adults during the COVID-19 pandemic. MEASUREMENT: The University of Illinois at Chicago (UIC) developed an expedited amendment process for research shifting to remote data collection. We conducted the study in three consecutive groups. For group 3, 14-month data collection period, we adapted our protocol to allow data collection via telephone and e-mail. We were unable to collect certain measures that required face-to-face contact. RESULTS: For measures that could be collected remotely, 14-month retention was similar for group 3 compared to groups 1 and 2: data were collected for 86.9% of group 3 (remote) and 87.9% of groups 1 and 2 (face to face), p = .84. CONCLUSIONS: In order to preserve the integrity of our clinical trial and ensure the safety of our participants and staff during the COVID-19 pandemic, we had to carefully and efficiently adapt our data collection procedures. The procedures put in place allowed us to collect our primary outcomes and the majority of our secondary outcomes and will enable us to examine the role of dietary intake, with and without weight loss, on cognitive functioning in a vulnerable and high-risk population. TRIAL REGISTRATION: ClinicalTrials.gov NCT3129048. Registration Date: 4/17/2017.

Adapting to the impact of the COVID-19 pandemic on a randomized controlled trial examining lifestyle behaviors on cognitive functioning in obese African American adults: Building Research in Diet and Cognition (BRIDGE).

Background . The COVID-19 pandemic has significantly altered the research landscape for clinical trials, requiring thoughtful consideration regarding how to handle the risks and benefits of continuing them. Design . This brief report describes the experience of adapting the Building Research in Diet and Cognition (BRIDGE) study, a randomized clinical trial examining the effects of the Mediterranean Diet, with and without weight loss, on cognitive functioning in 185 older obese African American adults during the COVID-19 pandemic. Measurement . The University of Illinois at Chicago (UIC) developed an expedited amendment process for research shifting to remote data collection. For the Cohort 3, 14-month data collection period, we adapted our protocol to allow data collection via telephone and e-mail. We were unable to collect certain measures that required face-to face contact. Results . For measures that could be collected remotely, 14-month retention was similar for Cohort 3 and earlier cohorts: data were collected for 86.9% of cohort 3 (remote) and 87.9% of cohorts 1 and2 (face to face), p = .84. Conclusions . In order to preserve the integrity of our clinical trial and ensure the safety of our participants and staff during the COVID-19 pandemic, we had to carefully and efficiently adapt our data collection procedures. The procedures put in place allowed us to collect our primary outcomes and the majority of our secondary outcomes and will enable us to examine the role of dietary intake, with and without weight loss, on cognitive functioning in a vulnerable and high-risk population. ClinicalTrials.gov NCT03129048.

Building research in diet and cognition (BRIDGE): Baseline characteristics of older obese African American adults in a randomized controlled trial to examine the effect of the Mediterranean diet with and without weight loss on cognitive functioning.

In the United States, >5.4 million people age 65 and older are affected by cognitive impairment and dementia, including Alzheimer's disease. African Americans are more likely than non-Hispanic whites to suffer from these disorders. Obesity is linked to accelerated age-related cognitive decline, and weight loss through caloric restriction is a potential strategy to prevent this cognitive impairment. Adherence to a healthful dietary pattern, such as the Mediterranean Diet (MedDiet), has also shown positive effects on reducing risk for dementia. African Americans are disproportionately affected by obesity and have less healthful diets than non-Hispanic whites. We present baseline characteristics from a three-arm randomized controlled trial that randomized 185 obese (BMI ≥ 30 kg/m2 and ≤ 50 kg/m2) healthy older adults (55-85 years of age) to: 1) Typical Diet Control (TDC); 2) MedDiet alone (MedDiet-A) intervention; or 3) MedDiet caloric restricted intervention to promote weight loss (MedDiet-WL). The majority of the sample was African American (91.4%) and female (85.9%). The two active interventions (MedDiet-A and MedDiet-WL) met once weekly for 8 months, and the TDC received weekly general health newsletters. Baseline data were collected between January 2017 and July 2019 in Chicago, IL. In our sample, closer adherence to a MedDiet pattern was associated with higher attention and information processing (AIP) and higher executive functioning (EF). Consistent with the literature, we saw that older participants performed more poorly on the cognitive assessments than younger participants, and women outperformed men across verbally mediated tasks, especially ones related to learning and memory.

Comparative Effectiveness Trial of an Obesity Prevention Intervention in EFNEP and SNAP-ED: Primary Outcomes.

There is a need to disseminate evidence-based childhood obesity prevention interventions on a broader scale to reduce obesity-related disparities among underserved children. The purpose of this study was to test the comparative effectiveness of an evidence-based obesity prevention intervention, Hip-Hop to Health (HH), delivered through Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) versus the standard curriculum delivered by the programs (Standard Nutrition Education (NE)). A nonequivalent control group design was delivered to compare the effectiveness of HH to NE on weight gain prevention and health behavior outcomes at EFNEP and SNAP-Ed sites. One hundred and fifty-three caregiver-child dyads (n = 103 in the HH group; n = 50 in the NE group) participated in the study. HH is an evidence-based dietary and physical activity intervention for low-income preschool children. The NE curriculum provided lessons for children that are consistent with the Dietary Guidelines for Americans 2010. Data were collected on demographics, anthropometrics, and behavioral variables for parent-child dyads at baseline and postintervention. Mixed model methods with random effects for site and participant were utilized. No differences in child or caregiver diet, physical activity, or screen time by group were found. No between-group differences in child BMI z-score were found; however, caregivers in the HH group lost significantly more weight than those in the NE group. Results from this trial can inform future dissemination efforts of evidenced-based programs for underserved families.

Building research in diet and cognition: The BRIDGE randomized controlled trial.

Obesity has been linked to cognitive impairment, cognitive decline and dementia. Given that 38.5% of U.S. adults 60years and older are obese and these numbers are rapidly increasing, strategies to decouple obesity from cognitive decline are needed. Innovative lifestyle strategies that may postpone the onset of subclinical symptoms or even arrest the transition to overt dementia in at-risk individuals are critically needed. Poor diet is central to the development of obesity and diet may affect cognition. Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia. Furthermore, weight loss through caloric restriction improves cognitive function. This paper describes the Building Research in Diet and CoGnition (BRIDGE) study, a randomized trial examining the effect of the MedDiet, with and without weight loss, on cognitive functioning in obese older adults. Obese (BMI≥30 and ≤50kg/m2) older adults (≥55years) (n=180) will be randomized in a 2:2:1 allocation scheme to: Typical Diet Control; MedDiet alone, without weight loss; or MedDiet lifestyle intervention to promote weight loss and weight loss maintenance. Both MedDiet intervention groups will meet for one individual session and 27 group sessions over an 8-month period. Individuals in the control group will not receive instruction on changing lifestyle habits. Outcomes will be assessed at baseline, 8 and 14months. The primary outcome is cognitive functioning; secondary outcomes will include changes in body weight, diet, cardiovascular, metabolic, and inflammatory biomarkers.

Health Behavior and Weight Changes Among Ethnic and Racial Minority Preschoolers and Their Parents: Associations Across 1 Year.

OBJECTIVE: To determine whether parent health behavior changes and feeding practices were associated with child changes in body mass index z-score and related health behaviors over the course of 1 year. METHODS: Anthropometric data from 590 child-parent dyads of ethnic/racial minority groups were collected at baseline, 14 weeks (postintervention), and 1-year follow-up. Additionally, parent screen time and feeding practices and child dietary consumption, diet quality, physical activity, and screen time were collected. RESULTS: Random effects growth models revealed that changes in child screen time moved in tandem with parent screen time from baseline to 14-week postintervention and from postintervention to 1-year follow-up. Greater parental monitoring predicted greater reduction in child calorie consumption at 1 year. CONCLUSIONS: Future studies should include innovative ways to explicitly involve parents in prevention efforts.

Hip-Hop to Health Jr. Randomized Effectiveness Trial: 1-Year Follow-up Results.

INTRODUCTION: The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child's life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. DESIGN: RCT. SETTINGS/PARTICIPANTS: Primarily African American children (aged 3-5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. METHODS: Eighteen preschools were randomly assigned in 2007-2008 to receive either (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors or (2) a 14-week teacher-delivered general health curriculum (control group). MAIN OUTCOME MEASURES: The primary outcome, BMI, was measured at baseline, postintervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. RESULTS: Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. CONCLUSIONS: The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT00241878.

Retaining traditionally hard to reach participants: Lessons learned from three childhood obesity studies.

Retaining underserved populations, particularly low-income and/or minority participants in research trials, presents a unique set of challenges. In this paper, we describe the initial retention strategies and enhanced the retention strategies over time across three childhood obesity prevention trials. Hip-Hop to Health Jr. (HH) was a randomized controlled trial (RCT) testing a preschool-based obesity prevention intervention among predominately African-American children. Retention was 89% at 14-weeks, 71% at 1-year, and 73% at 2-year follow-up. Primary retention strategies for HH included: 1) collaboration with a community-based organization to enhance program credibility; 2) continuity of data collection locations; 3) collecting detailed contact information and provision of monetary compensation; and 4) developing a detailed tracking/search protocol. In a follow-up trial, Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial (HH Effectiveness), 95% of participants completed assessment at 14 weeks and 88% completed assessment at 1 year. For this trial, we emphasized staffing continuity in order to enhance participant relationship building and required data collection staff to have relevant community service experience. In a third study, we assessed dietary quality among participants in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) across three time points following the WIC food package shift instituted nationally in 2009. Retention rates were 91% at 12 months and 89% at 18 months. For our WIC\ study, we augmented retention by developing a home data collection protocol and increased focus on staff diversity training. We conclude with a summary of key strategies and suggestions for future research.

Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families.

The 18-month impact of special supplemental nutrition program for women, infants, and children food package revisions on diets of recipient families.

BACKGROUND: Beginning in 2009, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) revised its food packages and provided more whole grains, fruits, and vegetables and fewer foods with high saturated fat content. However, knowledge of the impact of this policy shift on the diets of WIC participants remains limited. PURPOSE: To examine the longer-term impact of the 2009 WIC food package change on nutrient and food group intake and overall diet quality among African American and Hispanic WIC child participants and their mothers/caregivers. METHODS: In this natural experiment, 24-hour dietary recalls were collected in the summer of 2009, immediately before WIC food package revisions occurred in Chicago IL and at 18 months following the food package change (winter/spring 2011). Generalized estimating equation models were used to compare dietary intake at these two time points. Data were analyzed in July 2013. RESULTS: Eighteen months following the WIC food package revisions, significant decreases in total fat (p=0.002) and saturated fat (p=0.0004) and increases in dietary fiber (p=0.03) and overall diet quality (p=0.02) were observed among Hispanic children only. No significant changes in nutrient intake or diet quality were observed for any other group. The prevalence of reduced-fat milk intake significantly increased for African American and Hispanic children, whereas the prevalence of whole milk intake significantly decreased for all groups. CONCLUSIONS: Positive dietary changes were observed at 18 months post policy implementation, with the effects most pronounced among Hispanic children.

Evaluating the initial impact of the revised Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) food packages on dietary intake and home food availability in African-American and Hispanic families.

OBJECTIVE: The present study assessed the impact of the 2009 food packages mandated by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) on dietary intake and home food availability in low-income African-American and Hispanic parent/child dyads. DESIGN: A natural experiment was conducted to assess if the revised WIC food package altered dietary intake, home food availability, weight and various lifestyle measures immediately (6 months) following policy implementation. SETTING: Twelve WIC clinics in Chicago, IL, USA. SUBJECTS: Two hundred and seventy-three Hispanic and African-American children aged 2-3 years, enrolled in WIC, and their mothers. RESULTS: Six months after the WIC food package revisions were implemented, we observed modest changes in dietary intake. Fruit consumption increased among Hispanic mothers (mean = 0·33 servings/d, P = 0·04) and low-fat dairy intake increased among Hispanic mothers (0·21 servings/d, P = 0·02), Hispanic children (0·34 servings/d, P < 0·001) and African-American children (0·24 servings/d, P = 0·02). Home food availability of low-fat dairy and whole grains also increased. Dietary changes, however, varied by racial/ethnic group. Changes in home food availability were not significantly correlated with changes in diet. CONCLUSIONS: The WIC food package revisions are one of the first efforts to modify the nutrition guidelines that govern foods provided in a federal food and nutrition assistance programme. It will be important to examine the longer-term impact of these changes on dietary intake and weight status.

Racial/ethnic differences in dietary intake among WIC families prior to food package revisions.

OBJECTIVE: To compare the diets of African American and Hispanic families in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) prior to the 2009 food package revisions. METHODS: Mother-child dyads were recruited from 12 WIC sites in Chicago, IL. Individuals with 1 valid 24-hour recall were included in the analyses (n = 331 children, n = 352 mothers). RESULTS: Compared to their African American counterparts, diets of Hispanic mothers and children were lower (P < .001) in percentage of calories from fat, added sugars, sodium, and sweetened beverages, but higher (P < .001) in vitamin A, calcium, whole grains, fruit, and total dairy. However, no groups met national recommendations for percentage of calories from saturated fat, fiber, sodium, whole grains, vegetables, and total dairy. CONCLUSIONS AND IMPLICATIONS: There are racial/ethnic differences in dietary intake, and future research is needed to determine whether diets improve as a result of package revisions and whether uptake of these changes varies by race/ethnicity.