Treatment Trials

13 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease
Description

This study aims to investigate the feasibility of increasing dietary consumption of a rich variety of fruits and vegetables (including those that are potassim-rich) in patients with chronic kidney disease through use of nutritional counselling and hyperkalemia management with patiromer

TERMINATED
School Lunch Salad Bars and Fruit and Vegetable Consumption
Description

The investigators propose an efficacy study (i.e., do salad bars work under controlled conditions in naturalistic settings) to test whether introducing salad bars in elementary, middle, and high schools that have never had salad bars affects students' FV consumption and waste during lunch. A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase .

COMPLETED
Nutritional PSA's on Fruit and Vegetable Consumption
Description

The overall goal of this project is to learn how positive advertising messages impact school food choices. More specifically, this study will determine if positive video messages about fruits and vegetables delivered during the elementary school morning news program can influence children to select more fruits and vegetables in a school lunch setting. Additionally, it will determine if assessing food selection is representative of food consumption by children in a school lunch room setting.

COMPLETED
Effectiveness and Implementation of a Research Tested Mobile Produce Market
Description

Investigators will test the effectiveness of the Veggie Van model across multiple organizations and sites using a cluster-randomized design and will document the implementation process to understand what factors are associated with dietary change and sustainability.

COMPLETED
Market to MyPlate: Investigating the Impact of a Nutrition and Hands-On Cooking Intervention
Description

Recent peer-reviewed research indicates that low-income families are at higher risk for unhealthy dietary intake and associated poor health outcomes. Interventions that teach individuals from low-income families about cooking and healthy eating are warranted to improve overall dietary behaviors. The purpose of this study is to evaluate the impact of the Market to MyPlate Program on participants' reported cooking, shopping, and dietary behaviors using a cluster randomized trial design, where class cohorts are randomly assigned to education with produce allocations, education only, or control conditions. A secondary aim is to collect program feedback and better understand facilitators and barriers to farmer's market use and food waste reduction.

ENROLLING_BY_INVITATION
Eatable Alphabet as a Nutrition Education Tool
Description

This pilot randomized controlled trial will test the effectiveness of Eatable Alphabet cards, a child friendly nutrition education tool, on child weight and related behaviors in a clinical sample of 2 to 10-year-old children with overweight/obesity, referred to a pediatric weight management program.

COMPLETED
Reducing Food Insecurity During COVID-19
Description

This study aims to compare the effectiveness of two interventions to address food insecurity among low-income families with young children during the COVID pandemic. The investigators will conduct a parallel group, randomized controlled trial of 250 families. The first randomly assigned comparator is Fresh Connect, a produce prescription program that provides a stipend for participants to purchase fresh food items at mobile markets and independent farmers markets across Boston. The second comparator is grocery store gift cards, redeemable at conventional grocery stores. In each comparator, participants will be given the equivalent of $150 on a monthly basis for six consecutive months. All participants will be followed for 12 months to assess outcomes that involve food insecurity (primary), fruit and vegetable consumption, healthcare utilization, social service utilization, and physical/emotional health.

Conditions
WITHDRAWN
Fresh Truck Pilot to Reduce Food Insecurity in a Medicaid ACO
Description

This research is a randomized pilot study of an intervention to address food insecurity among intermediate risk Boston Accountable Care Organization (BACO) members receiving primary care at Boston Medical Center (BMC). The investigators propose a parallel group, randomized pilot study among intermediate risk Medicaid ACO patients at BMC who have experienced food insecurity in the past 12 months, with a total enrollment of 120 participants (N=120). Half of the pilot study participants (n=60) will receive usual care: tailored printed paper referral guides to address health-related social needs, including resources for food insecurity (via the Health System's THRIVE Screening \& Referral Program) and referrals to Boston Medical Center's Preventative Food Pantry. The other half (n=60) will receive access to a mobile fresh produce market and a monthly stipend to purchase items available on the mobile food trucks. This pilot study will partner with Fresh Truck, a Boston-based 501(c)(3) organization that deploys mobile fresh produce trucks throughout Boston neighborhoods. Fresh Truck recently launched a new system, called 'Fresh Connect,' which addresses affordability as a barrier to healthy eating. 'Fresh Connect' enables healthcare systems to pay for fresh produce purchased by their patients from the Fresh Truck mobile markets. The study protocol comprises three steps: * Risk stratification before consent process to determine if the patient, at baseline, is within the top 3-20% of cost and utilization among BACO members. (This process is part of usual care operations in the Health System for ACO members). * Of BACO patients identified as intermediate risk, patients will be screened for proximity to Fresh Truck mobile markets (zip code is among current Fresh Truck service area), nutritional need (food insecurity identified in the last 12 months), and not documented as housing insecure. * Half the pilot study population will receive access to a mobile fresh food market intervention, Fresh Truck, and a stipend to purchase fresh produce aboard the trucks. The other half will receive usual care. Pilot study participation is 6 months and will include collection and measurement of data from the following sources: baseline interview; final (6-months post-enrollment) interview, electronic medical records (EMR), BMC Clinical Data Warehouse (BMC CDW), and BMC HealthNet Plan (BMCHP) claims.

Conditions
COMPLETED
Squire's Quest! II: Implementation Intentions and Children's Fruit, Juice, and Vegetable (FJV) Consumption
Description

The primary purpose of this research is to test the effects of goal setting on fruit and vegetable goal attainment and consumption in a 10 episode video game. Factors associated with maintenance of behavior change will also be examined. Secondary purposes are to explore the impact of the intervention on psychosocial factors and the home environment. 400 parent-child pairs will be recruited for this research (800 participants total). Children will play the video game and participate in data collection activities. Parents will receive newsletters, have access to a healthy foods web site, and participate in data collection activities. A small subset will be randomly selected to participate in interviews about the intervention and its effect on the home food environment.

Conditions
COMPLETED
Healthy Futures Project: A Community Based Obesity Prevention Program
Description

The purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management. The problem of obesity is at epidemic proportions and has become the most important public health problem confronting the United States today. Of greatest concern is the 300% increase in obesity rates among children and youth over the past twenty years. Childhood obesity is a precursor of adult obesity.

COMPLETED
Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption
Description

This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC).

COMPLETED
Childcare Outdoor Learning Environments as Active Food Systems
Description

The aim of this project is to assess the effectiveness of the fruit and vegetable (FV) gardening component of the Preventing Obesity by Design strategy to support preschool fresh fruit and vegetable knowledge, liking and consumption, and physical activity in children 3-5 years old living in under-resourced communities and attending childcare using a Randomized Controlled Trial research design. Sample: 15 childcare centers, 286 children.

COMPLETED
Multiple Risk Behavior Intervention in Health Care Settings
Description

This study (aka Healthy Directions2 or HD2) builds on an earlier study titled Healthy Directions (aka Healthy Directions 1 or HD1). HD1 was an intervention designed to target cancer prevention among multi-ethnic populations; it led to significant improvements in the multiple risk behavior score (consumption of red meat, fruits and vegetables, and multi-vitamins). Building on the success of HD1, HD2 further expanded the intervention to include smoking and physical activity. In addition, it expanded the study goals to include increasing efficacy across all target risk behaviors, and promoting long-term maintenance of behavior change.