Treatment Trials

36 Clinical Trials for Various Conditions

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COMPLETED
Cooking Matters for Diabetes - A 6-Week Program for Practical Application of Diabetes Self-Management Education
Description

Our primary objective is to improve glycemic control (Hemoglobin A1c \[HbA1c\]) over 3 months in individuals with diabetes by teaching practical application of diabetes education through "Cooking Matters" compared to usual care. Our secondary objective is to improve health related quality of life, adherence to diabetes self-management behaviors (physical activity, diet, glucose monitoring, and medication adherence) over 3-months compared to usual care. We hypothesize that participants in the cooking matters intervention will have significant improvement in glycemic control (HbA1c), HRQOL, and adherence to diabetes self- management compared to usual care. Our study is significant as it examines a novel approach to improving diabetes care and addressing glycemic control in diabetes.

COMPLETED
Cooking as a Health Behavior in College Students
Description

Students who live off campus at the University of Vermont will be recruited to participate in the study which will begin in Fall 2019 and run through May 2020. The intervention is a randomized-controlled trial where students will be randomized into one of four conditions: 1) Active cooking classes followed by meal kits and recipes, 2) Active cooking classes followed by no further instruction, 3) No cooking classes followed by meal kits and recipes, or 4) No intervention. Assessments will be conducted at baseline and following each phase.

Conditions
COMPLETED
Fuel for Fun: Cooking With Kids Plus Parents and Play
Description

Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research, extension, and education project targeting 4th grade students. Its long-term goal of reducing the risk of childhood obesity will be addressed by promoting healthful food and activity environments, policies and behaviors through: 1) building and testing the efficacy of a 4th grade comprehensive school- and family-based intervention, 2) applying it to an after-school setting to broaden its reach, and, 3) disseminating both versions through outreach.

COMPLETED
Peer-mentored Cooking Classes for Parents of Toddlers: Do Families Cook More and Eat Healthier After the Intervention?
Description

This study aims to test the effectiveness of a community-located, peer mentored intervention to improve home food preparation practices in families with young children.

Conditions
NOT_YET_RECRUITING
The Cooking for Health Optimization and Disease Prevention (CHOP) Trial
Description

Poor nutrition-related diseases disproportionately impact seniors and racial/ethnic minorities who are more likely to experience disparities in proper nutrition. Culinary medicine is a new evidence-based educational approach that blends the art of food and cooking with the science of medicine. Recently, culinary medicine is proposed by the 2020-2030 Strategic Plan for NIH Nutrition Research and national 'Food is Medicine (FIM)' Movement as potential solutions for improving healthy eating, creating social and emotional connections, and nutrition-related health equity. Built upon the well-established community teaching kitchen at The Goldring Center for Culinary Medicine (GCCM) at Tulane University and nearly 10 years of experience in delivering culinary education of Mediterranean diet (MedDiet), the investigators will conduct a randomized controlled trial (RCT) to test the feasibility and effectiveness of 3-month community teaching kitchen-based culinary education of MedDiet on improving cardiometabolic and mental health among racially and ethnically diverse seniors.

RECRUITING
Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities
Description

The goal of this study is to see if adding hands-on cooking classes to a weight management program (called Chef-ID) helps young adults with intellectual disabilities lose more weight and keep it off compared to a standard weight loss program. The study will last 24 months and include three phases: 6 months of active support, 12 months of maintenance, and 6 months with no contact. The investigators will look at how much weight participants lose over the first 18 months. Changes in cooking skills, body fat, health markers (like blood pressure and cholesterol), daily living skills, and caregiver stress will be tracked. Finally, factors that might help or prevent weight loss, and how changes in weight and body fat are linked to overall health will be explored. This research will help inform on how to better support healthy lifestyles for people with intellectual disabilities.

NOT_YET_RECRUITING
Cooking HEalthy and Facilitating Early Childhood Development: CHEF-ED Study
Description

This study aims to test a new online program we developed for parents and their preschool children, called CHEF-ED. CHEF-ED focuses on healthy cooking, parental feeding practices, and involving children in home food preparation.

NOT_YET_RECRUITING
Giving Healthy Meal Kits and Cooking Lessons to Rural Families with Food Insecurity.
Description

The goal of this clinical trial is to learn if providing healthy meal kits to food insecure families can help lessen the social and emotional impacts of food insecurity on kids and their caregivers in rural Maine. The main questions it aims to answer are: 1. Is receiving healthy meal kits delivered to homes feasible and acceptable to rural Maine families? 2. Does receiving meal kits (along with an app to help learn how to cook the food) improve food insecurity and diet quality in rural Maine families? 3. Does receiving meal kits (along with an app to help learn how to cook the food) improve family function in rural Maine families? We will look at caregivers' stress, family conflict, household chaos, and child emotional-behavioral symptoms. Participants will: 1. Recieve and prepare a dietitian-designed meal kit with 10 meals per week for 4 weeks. 2. Receive free culinary medicine education via an app that they will continue to have access to after the study ends. 3. Complete a 1-1.5 hour virtual visit at the beginning of and end of the study.

COMPLETED
Cooking for Your Health in Southern New Mexico: an 8-week, Bilingual (English and Spanish) Nutritional Intervention in Adults Living in Doña Ana and Otero Counties
Description

This clinical trial evaluates a nutritional intervention called Cooking for Your Health in Southern New Mexico for improving diet quality and knowledge related to nutrition and cancer prevention among individuals living in the Southern region of New Mexico. New Mexico border communities have high rates of cancer and obesity, both exacerbated by poor diet quality. Traditional Mexican diets are high in fruit, vegetables, and fiber, but are intensive to prepare and not practical for many families living in New Mexico now. Vegetable oils, such as canola, safflower, and sunflower oils, are commonly used in cooking within the regional New Mexican community because they are inexpensive and readily available; however, they may not be as healthy as other options. Interventions focused on teaching proper cooking techniques and raising awareness about nutritious foods have shown positive behavior changes, including greater preference for healthier foods, increased confidence in food preparation and cooking a balanced meal, and higher vegetable variety and availability in the home. This study may help identify effective and culturally relevant real-world strategies to improve knowledge, skills, behaviors, and access to resources to improve nutrient intake, with the long-term goal of decreasing cancer risk and chronic disease risk in southern New Mexican communities.

RECRUITING
Advanced Cooking Education Full Scale Study
Description

The aim of this study is to assess the impact of an in-person multi-component Advanced Cooking Education (ACE) 4-H after school program. The ACE Program consists of mindfulness, nutrition education, cooking labs, and professional development activities.

RECRUITING
'Ai Pono Cooking Demonstrations
Description

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

COMPLETED
Advanced Cooking Education Pilot Study
Description

The aim of this study is to assess the impact of an in-person multi-component Advanced Cooking Education (ACE) 4-H after school program. The ACE Program consists of mindfulness, nutrition education, cooking labs, and professional development activities.

COMPLETED
Advanced Cooking Education Feasibility Study
Description

The aim of this study is to look at outcomes related to diet and nutrition, mindfulness, and cooking skills amongst middle school students who participated in a 12-week 4-H after school program called the Advanced Cooking Education Program.

COMPLETED
Cooking Classes for Young Adults With ID
Description

The purpose of this study is to examine the feasibility and initial efficacy of a healthy lifestyles intervention for the prevention of weight gain and the promotion of basic life skills related to improving health in transition age young adults with intellectual disabilities.

COMPLETED
Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes
Description

In this pilot trial participants will be randomized 1:1 to participate in either standard Diabetes Prevention Program (DPP) vs. DPP plus a novel cooking skills intervention (DPP Cooks). The researchers hypothesize that participants randomized to DPP Cooks will have greater weight loss, better diet quality at 4 months, and greater confidence in their cooking skills and ability to implement dietary changes recommended in the DPP.

Conditions
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.

COMPLETED
Examining Cooking as a Health Behavior
Description

The proposed pilot study will examine cooking as an intervention target for weight control in overweight adults. The study will also examine whether interventions designed to promote cooking at home can increase participants' sense of food agency, and overcome common barriers to cooking at home such as time scarcity and budget constrictions. The study will utilize a cooking pedagogy designed to not just teach participants the basics of cooking different foods, but how to be efficient, mindful cooks. If cooking class participation positively impacts diet and health outcomes, it will bolster the case for promoting cooking at home as a health behavior for multiple populations.

Conditions
COMPLETED
Cooking for Health
Description

Type 2 diabetes is a leading cause of morbidity and mortality among American Indians (AIs) in the United States. Although healthy diet is a key component of diabetes management programs, many AIs face barriers to adopting a healthy diet including: difficulty budgeting for food on low-incomes, low literacy and numeracy when purchasing food, and limited cooking skills. The proposed project will evaluate a culturally-targeted healthy foods budgeting, purchasing, and cooking skills intervention aimed at improving the cardio-metabolic health of AIs with type 2 diabetes who live in rural areas.

COMPLETED
Cooking for Health Optimization With Patients
Description

Cooking for Health Optimization with Patients (CHOP) is the first known multi-site prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive cardiology field of culinary medicine. It is also the first known longitudinal study to assess the impact of hands-on cooking and nutrition education on patient outcomes, with those classes taught by medical students and other future and current medical professionals who have first been trained in those classes on how to integrate diet and lifestyle counseling of patients with their respective scopes of clinical practice. CHOP is the primary research study of the world's first known medical school based teaching kitchen, The Goldring Center for Culinary Medicine at Tulane University School of Medicine. Medical trainees and professionals are followed in this study long-term to understand how the classes impact their competencies in patient counseling, attitudes about the counseling, and their own diets. Patients who consent to being randomized to these classes compared to standard of care are studied within the nested Bayesian adaptive randomized trial to understand how the classes impact their health outcomes, clinical and food costs, and the costs of health systems caring for these patient populations. CHOP is designed as a pragmatic population health trial to hopefully improve healthcare effectiveness, equity, and cost by establishing an evidence-based, scalable, sustainable model of healthcare intervention targeting the social determinants of health, while complementing the pharmacological and/or surgical management of patients.

COMPLETED
Skill-based Cooking Intervention to Reduce Eating Out
Description

The primary goal of the study is to use an iterative process to develop and refine a skill-based cooking intervention to decrease the consumption of energy from foods prepared away from home for evening meals, decrease energy intake, and promote a healthy weight in parents and children aged 3-10 years.

Conditions
COMPLETED
Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children
Description

The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich in medium chain triglycerides on energy expenditure and food intake in overweight and obese children.

TERMINATED
A Cooking and Eating Study
Description

Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances were once considered the primary concerns, emerging data indicate that many adolescents and young adults with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body fat amplifies the severity of the syndrome. Dietary intervention is considered an important component of treatment for PCOS. However, a consensus statement regarding optimal nutrient composition for treating adolescents and young adults with PCOS has not been published because data are lacking to provide a foundation for such a statement. Recognizing increased risk for diabetes in patients with PCOS, many practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP) for weight loss and control of symptoms. Objective and Hypothesis. The purpose of this research study is to compare different diets for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood levels of glucose and insulin - will be more beneficial than a low-fat diet in obese adolescents and young adults with PCOS. Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years) will be assigned to receive one of two dietary treatments, with the goal of retaining 40 participants. Group assignment will be at random. One of the treatments will be a low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP diet). Participants in both groups will receive individual nutrition education and dietary counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops with a chef. The purpose of the cooking workshops will be to enhance compliance with diet prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a conventional clinic setting. The primary outcome will be bioavailable testosterone (form of testosterone that causes symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high androgen levels (total testosterone, free testosterone, sex hormone binding globulin, dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair, acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive protein levels and blood pressure), body fat percentage and distribution (measured using state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual cyclicity, and health-related quality of life (evaluated by questionnaire).

RECRUITING
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
Description

Background: The risk of heart disease among African Americans is still common despite a greater understanding of the disease and better approaches to managing it. Healthy cooking and eating patterns can help reduce the risk of heart disease. But things like access to grocery stores and knowledge of good nutrition can affect these healthy patterns. Researchers want to see if community-based programs can help. Objective: To learn about the cooking behaviors of African American adults at risk for heart disease. Also, to see if a community-based cooking intervention will affect home-cooking behaviors. Eligibility: African American adults 18 and older who live in Wards 7 and 8 of Washington, D.C., and have at least one self-reported risk factor for heart disease Design: Phase I participants will complete a survey. It asks about their medical history, lifestyle, stress level, and eating habits. They will take part in a focus group. During this, they will talk about what they eat and what foods are available to them. Participation lasts 1 day for 3 hours at Pennsylvania Avenue Baptist Church in Washington, D.C. Phase II participants will go to shared cooking events at Pennsylvania Avenue Baptist Church. These will be held once a week for 6 weeks. They will be led by a trained chef. Participants will visit the NIH Clinical Center 3 times. Transportation will be provided if they need it. They will have physical exams and have blood drawn. They will be interviewed and complete questionnaires. A dietician will review the food they eat. An occupational therapist will assess their cooking skills. They will keep a daily cooking journal. Participation lasts 18 weeks. ...

Conditions
RECRUITING
MIND Foods and Aerobic Training in Black Adults With HTN
Description

The goal of this randomized controlled trial is to determine the impact of Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet and aerobic training on cognition in Black adults with high systolic blood pressure. Researchers will compare Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) versus Enhanced Usual Care (EUC) to evaluate the effects on cognition. Participants will complete cognitive and cardiovascular assessments, 24-hr blood pressure monitoring, standard blood pressure measurements, weight, fingerstick for HbA1c point-of-care testing, and questionnaires. Participants may also choose to participate in an optional blood draw for DNA Repair Capacity testing as a modifiable risk factor for aging-associated diseases.

COMPLETED
Fruit and Vegetable Rx (FVRx) + Home Plate
Description

This is a research study to test if fruit and vegetable prescription vouchers (FVRx) and a cooking skills program (Home Plate) can improve dietary quality, food security (access to a sufficient quantity of affordable, nutritious food), feelings about the home and community food environments, and caregiver mental health.

Conditions
COMPLETED
AIM to Improve Asthma: Airflow Improvements During Meal-Prep
Description

The investigators propose a pilot trial of kitchen ventilation in the homes of children using a youth engaged research strategy.

COMPLETED
Lifestyle Education and Nutrition Demonstration
Description

The Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven track record of engaging patients in healthy living and eating through education, live cooking demonstrations / hands-on cooking classes, exercise and stress management programs. As a result of the Community Health Needs Assessment, we are collaborating with Cleveland Clinic Community Outreach and 12th District Representative, John E. Barnes, Jr., to extend our expertise to the community of Warrensville Heights, Ohio.

Conditions
COMPLETED
Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers
Description

This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children.

Conditions
COMPLETED
Rouxbe Pilot for MS
Description

The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS) patients who are participating in a pilot cooking course. This online cooking training program is currently available to general public through the company "Rouxbe" for a fee. Data gathered from this cooking course will be used to develop novel ways of promoting healthy eating habits in people with MS. The investigators will use the data from blood tests, questionnaires, and demographics to assess the feasibility and effectiveness of this program. This is an outpatient program designed for people with MS that would occur regardless of whether participant data is collected. This pilot cooking course will run for approximately four weeks. The investigators intend start to the training course in mid-March 2015. Subjects will be followed prior to course initiation for baseline data gathering, at four weeks from baseline, twelve weeks from baseline, and twenty-four weeks from baseline.

COMPLETED
LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth
Description

The overall goal of this project is to conduct a randomized controlled 12-week after school, gardening, nutrition and cooking program (called "LA Sprouts") to improve dietary intake and reduce obesity in 3rd, 4th and 5th grade students (ages 8-12 years) in Los Angeles. Approximately 400 3rd - 5th grade students participating in the LA's Best after school program will participate. Four elementary schools in Los Angeles will be selected to participate in the study. Schools will be randomized by region to either receive the intervention (LA Sprouts; 2 schools, n=200 students) or serve as controls (received a delayed intervention program one school semester later; 2 schools, n=200 students). The LA Sprouts intervention will take place at the elementary schools, with gardens on campus specially designed and built for this project. The program will be held once a week for 12 weeks and will consist of a 45-minute gardening lesson, taught by Master Gardeners from the University of California Cooperative Extension (supervised by Nicole Gatto, MPH, PhD), and a 45-minute nutrition education and cooking lesson, taught by USC a Nutrition Educator (supervised by Jaimie Davis, PhD, RD). Measures of childhood obesity (i.e., body mass index (BMI) and body fat percentages), blood pressure, metabolic function (fasting blood glucose, insulin and lipids), dietary intake and related behaviors, and school performance will be measured before and after the implementation of the program in both intervention and control participants. Approximately 10 additional students of the same age will be asked to participate in a focus group to evaluate the questionnaire developed for this study. In addition, approximately 20 additonal students of the same age will be asked to participate in a test-retest session to validate the reliability of the questionnaire.