165 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if an Internet-based behavioral intervention can increase physical activity and improve diet quality among Latina adults. The main question aims to answer is whether participants in the Internet-based behavioral intervention group increase their physical activity levels, increase their consumption of fruits and vegetables, and decrease their consumption of sugar-sweetened beverages over 12 weeks. Researchers will compare the Internet-based physical activity and healthy eating intervention to a wait-list control group (participants who do not receive any intervention until after completing the study) to see if the Internet-based behavioral intervention works to improve physical activity and diet quality. Participants who receive the Internet-based behavioral intervention receive access to the online intervention for 12 weeks, and complete assessments at baseline and week-12. Participants in the wait-list control complete the same assessments at baseline and week 12, then receive access to the online intervention for 12 weeks.
The goal of the LEAP project is to improve the health and well-being of cancer survivors and their co-survivors living in persistent poverty areas by providing healthy behavior change support. This will be done by engaging the community in adapting beneficial approaches for promoting healthy diet and regular physical activity into a program for cancer survivors and co-survivors that is appropriate for the persistent poverty context and social determinants of health.
Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children. The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called CASA (Comunidad, Alimentacion, Seguridad y Amen). Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (the CASA) in collaboration with Hispanic churches and their congregants. SA2. To conduct the CASA intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention. SA3. To assess the impact of the CASA intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child). The investigators will compare between the intervention group (16 mother-child dyads) versus the control/attention group (16 mother-child dyad) to see if the intervention is effective in improving diet quality and changing cooking behaviors. Participants will: 1. Participate in cooking workshops and one to one learning activities 2. Report on diet and physical activity 3. Will measure fruit and vegetable intake
This study is a human-centered, three-arm, parallel-group, randomized control, implementation trial (n=75) to compare MTM (Medically Tailored Meals) only (14 meals delivered weekly for 10 weeks) vs. MTM + SMA (Shared Medical Appointments; once weekly sessions for 10 weeks) vs. a wait-list control group (MTM-Later) in patients with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. All intervention components will be culturally congruent (e.g., MTMs will include food that converges with culturally relevant diets and SMAs will be delivered by individuals with racial concordance to the target community). Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). Participants will be recruited from Cleveland Clinic's South Pointe Hospital in Warrensville Heights, a predominantly Black community with low socioeconomic status and high cardiovascular disease morbidity.
With funding from the United States Department of Agriculture (USDA), the Tufts University's Friedman School of Nutrition Science and Policy will be implementing a new, health and wellbeing program for Head Start educators at ABCD Head Start Centers in the greater Boston area. The purpose of this study is to evaluate the combined impact of a health and wellness program and behavior change guides. The evaluation will focus on ABCD Head Start educators as the study population. Tufts University's Friedman School of Nutrition Science and Policy is responsible for implementing and evaluating this new intervention through surveys and analysis of administrative (health and wellness App) data. A paper and pencil survey will be used to gather information on dietary, physical activity, and sleep behaviors. The surveys will also include a module on satisfaction with the health and wellness App and Guides. Survey data will be combined with the administrative data about App utilization.
The goal of this single-group prospective study is to examine the impact of the Healthy Eating and Active Lifestyle (HEAL) Breast Cancer program on participants' perceived stress, biometrics, basic labs, lifestyle behaviors, self-efficacy, mental health, and quality of life. Participants will participate in an 8-week program of 90-minute virtual sessions each week to decrease risk of cancer recurrence. Program participants can choose to participate in the research study which will include data collection (surveys, biometrics, basic labs). The data collection will occur at four timepoints - baseline prior to program start, post-program, 3 month follow-up, and 6 month follow-up.
The goal of this community-based randomized trial in elementary-aged children and a caregiver (parent/guardian) is to test the effect of providing families with produce and grocery store gift cards (family support) in conjunction with an after-school program for physical activity and healthy eating on improving children's overall diet, in comparison to the child only attending the after-school program without the family support. Participating families will: * receive weekly produce bags delivered to their home, recipes, and gift cards to a local grocery store (family support) * the child will attend the after-school program during the school year Researchers will compare the child's diet and eating scores with those in the after-school program alone.
The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.
Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.
This small scale healthy eating study provides Southeast Asian families with children ages 6 to 11 with a family-based nutrition education, one-on-one interviews to help with motivation to eat health, text messaging, and coupons to purchase health foods and beverages. Since this is a small scale study that is a pilot intervention, the main goal of this intervention is to determine if it is feasible, meaning, can it be done. The second goal of this intervention is to determine if there are meaningful improvements in children's healthy eating patterns, body mass index and HbA1c. The third goal is to see if the intervention improves parent's diet quality, HbA1c and the home food environment. These study findings will be used to determine whether a larger clinical trial is needed, and if so, how it should be done.
Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention - grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.
The aim of this mixed methods, single-group, single-center study will be to examine the feasibility of a food response training (FRT). This study will be conducted in patients with obesity recruited from NYU Langone Health. Measurements will occur at screening, baseline, and 3 months, for a subgroup of participants for we will collect saliva samples for genetic analysis at baseline assessment (ancillary study).
There is an unmet need for nutrition interventions that address both autism spectrum disorder (ASD) specific feeding challenges and unbalanced eating habits among children with ASD to prevent future chronic health conditions. Children with ASD tend to consume few fruit and vegetables and mainly high-energy dense foods, including sugar-sweetened beverages and processed snacks. Obesity prevalence in children with ASD is up to 40% higher than in typically developing children, and recent studies show significantly elevated risks of hyperlipidemia and hypertension among individuals with ASD, regardless of using psychotropic medications. Our interdisciplinary team conducted a preliminary study to examine diet quality and mealtime behaviors among diverse children with ASD in Florida (34% Hispanic/Latino) and parental preferences for nutrition interventions. Based on the study findings, we developed the manual for our nutrition intervention, Autism Eats, for children with ASD enrolled in the Part C of Individuals with Disabilities Education Act (IDEA) Early Intervention (EI) services. Our Autism Eats manual and parent materials are based on ASD-specific feeding strategies such as food chaining combined with behaviorally-focused nutrition intervention strategies such as goal setting and weekly meal planning to promote healthy eating. Among children with ASD enrolled in Part C EI services in Florida, we will conduct a randomized controlled trial (RCT) with the nutrition intervention program, Autism Eats, and the enhanced usual care (EUC) comparison program. The Autism Eats intervention is to prevent problematic mealtime behaviors and promote development of healthy eating habits. We expect that implementing the Autism Eats will be feasible and the intervention will be well-received by EI providers and parent-child dyads. We will examine differences in children's food intakes (fruit and vegetables), food variety, diet quality, and problematic mealtime behaviors between children in Autism Eats and those in the EUC groups at post-intervention and 5-month follow-up from baseline.
The Healthy Eating for Successful Living in Older Adults™ (HESL) is a six-week community nutrition and lifestyle education program designed specifically for the elderly (\>60 years), to promote dietary and behavioral changes towards a healthy lifestyle. The intervention was evaluated using a randomized-controlled trial.
Infants from underserved and minority backgrounds are at increased risk for obesity and poor feeding and nutrition outcomes, but obesity prevention programs tailored specifically to the needs of these infants are lacking. The current study takes a community-engaged approach to development and delivery of an adaptively tailored obesity prevention program delivered via home visiting to target infant eating and feeding (Healthy Eating for My Infant; HEMI).
This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.
This intervention aims to evaluate the efficacy of a pilot educational intervention with deep-structure cultural tailoring for Latino ethnic groups on diet quality compared to general, surface-level healthy-eating messages.
Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced exercise behaviors with the potential for this risk to worsen over time. With over 80% of pediatric cancer patients living to adulthood, many pediatric cancer survivors experience long-term health consequences such as heart disease - the leading cause of death in this population. The purpose of this clinical research study is to teach parents/caregivers skills that will help prevent and reduce the problems of obesity in childhood cancer survivors. In this study, parents have the opportunity to participate in one of two web-based groups in which parents in either group will learn valuable information to improve the health of their child and of themselves.
Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile App. Participants will be asked to complete baseline and 6-week follow-up surveys. The clinic session (offered in person or remotely) will include a needs assessment and a tailored care plan with information, educational materials and referrals about participants' symptoms, behaviors, social concerns and caregiving tasks. After the visit, the program will provide an App for caregivers with follow-up resources and mobile support for one month.
The primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds.
Adopting a healthy eating pattern is important for meeting dietary recommendations and weight management. Although less clear, it seems reasonable to assume that the eating patterns we typically follow can also affect our psychological wellbeing. As such, healthy eating patterns are often adapted to suit one's personal preference. For example, many people choose to follow a vegetarian-style eating pattern whereby meat, poultry, and seafood are excluded from the diet. However, current research suggests that vegetarian eating patterns may result in decreased synthesis of new muscle proteins when compared to the typical meat-based US-style diet. This ultimately leads to reduced muscle quality and mass which increases the risk of dependence and mobility limitations later in life. Another important factor to consider when adapting a healthy eating pattern is the frequency and distribution of meals throughout the day. In the US, protein intake is typically skewed throughout the day such that people consume more protein at dinner when compared to breakfast. This skewed distribution combined with a low meal frequency (3 meals per day) can also sacrifice the rate of muscle protein synthesis. As such, it is important to investigate the interaction between food choices, meal frequency, and protein distribution to promote muscle health and prevent development of disease and disability. In addition, it is also important to understand how these eating patterns affect enjoyment and pleasure following meals. This work will help to determine healthy eating patterns that promote muscle health and psychological wellbeing.
In this 2-phase trial (R61/R33), we propose Guys/Girls Opt for Activities for Life (GOAL). Guided by Self-Determination Theory and the Information-Motivation-Behavioral Skills Model, GOAL will target the school and home environment to increase young adolescents' physical activity (PA) and healthy eating by increasing important factors at the individual-level: motivation and self-efficacy; and socioenvironmental-level: social support. The 4-month (16-wk) GOAL intervention has 3 components: (1) After-school GOAL Club: 26 events (2 d/wk; 120 min/event/day; 13 weeks due to no club during 3 school break weeks) for boys and girls to engage in PA and healthy eating/cooking activities; (2) Three parent-adolescent meetings (1st meeting at each school, which is also conducted synchronously via Zoom to increase convenience for parents who are not able to meet in-person at the school for various reasons; 2nd and 3rd meetings video-recorded and delivered asynchronously to accommodate and meet the needs of busy parents who have varying schedules due to work, home, and other responsibilities): to empower parents to assist adolescents with PA and healthy eating/cooking; and (3) GOAL social networking website: private website (already developed) for parents to learn about healthy eating and PA, network with other parents, and share with each other about how they helped their adolescent(s) increase PA and diet quality each week. The purpose of this individual randomized controlled trial (unit of assignment is adolescent) is to evaluate the effect of GOAL on decreasing cardiovascular disease risk factors (high percent body fat, overweight/obesity, low cardiovascular fitness), improving quality of life; and increasing motivation, self-efficacy, and social support to increase moderate-to-vigorous PA and diet quality among adolescents (5th-8th grade) throughout the state of Michigan. All interested adolescents who meet eligibility criteria and have parental consent will be included. We are including all interested students and not only those who have a high BMI (e.g., BMI z-score ≥0 \[≥50th percentile\]), in order to avoid social stigma(s) discouraging adolescents from participating. Adolescents in each of 14 schools total will be randomly assigned to the intervention or control (usual school activities) condition. The plan is to include at least n=33 intervention and n=30 control adolescents in each school every year for 3 years of the R33 Phase. On average, we will include at least 63 adolescents per school (at least 31-32 boys and 31-32 girls) and one parent per adolescent will be enrolled, bringing our total sample size to at least 882 dyads total (882 adolescents and one parent per adolescent).
Most studies which have addressed food selectivity among children with autism spectrum disorders have been conducted in either clinic or home settings. School-based research has been conducted to increase healthy eating, but this research was largely conducted with children without special needs or if children with special needs did participate, they were not identified. This study will focus on increasing consumption of fruits and vegetables among children with an Autism Spectrum Disorder in a school setting.
This trial studies the effects of a dietary intervention based on the Alternative Healthy Eating Index (AHEI) on inflammatory markers and breast density in healthy participants. The AHEI is a quantifiable measure of diet quality designed to target food and macronutrient sources that are associated with chronic disease risk. Adherence to the AHEI may be associated with a reduction in inflammatory biomarkers and sex steroid hormone levels compared to other dietary patterns/scores.
The goal of this study is to develop and pilot test a telehealth behavioral weight control intervention for adolescents from a low-income background that combines facets of mindfulness training with behavioral weight control. We aim to examine biological (e.g., weight) and behavioral (e.g., emotional eating, mindfulness) changes as a result of a 12-session mindfulness-based weight control intervention compared to a 12-session standard behavioral weight control intervention.
Whole grains, non-starchy vegetables, fruit, and beans are a consistent feature of diets associated with a lower risk of cancer and other diet-related diseases. For cancer risk reduction, the American Cancer Society recommendation is to consume at least 2.5 cups of a variety of fruits and vegetables daily. Other than dietary choices, weight control and physical activity levels are important modifiable determinants of cancer risk. This study finalized a novel, theory-driven farm-to-WIC intervention developed in preliminary work to promote vegetable intake among low-income adults served by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). In New Jersey (the location of the study), WIC provides participants up to $30 in seasonal Farmers' Market Nutrition Program (FMNP) vouchers and monthly cash value vouchers or CVV (valued at $11 for adults and $8 for children at the time of the study) redeemable at farmers' markets. The program combined behaviorally focused nutrition education with the establishment of a WIC-based farmers' market (implemented in the summer of 2019 during the FMNP voucher issuance period). Content to address other modifiable determinants of cancer risk was added. To create additional opportunities for experiential and hands-on learning, monthly trips to an area farmers' market were held (between September 1, 2019 \[after the WIC-based market was discontinued\] and November 30, 2019 \[the end of the local growing season\]). The research employed an experimental design to initially test the intervention in 3 WIC agency sites (1 intervention and 2 control sites) with 297 urban, primarily Hispanic adults. Program effects on primary outcomes of vegetable intake (measured objectively using dermal carotenoids as a biomarker of intake and via self-report) and FMNP voucher redemption (objectively assessed using data provided by WIC) were examined at mid- and post-intervention (3 and 6 months post-baseline, respectively). Intervention effects on potential hypothesized mediators and the redemption of CVV at farmers' markets, participant satisfaction with the program, and the cost-effectiveness of the intervention also were examined.
The purpose of this study is to test the effectiveness of a new curriculum on toddlers' self-regulation skills and healthy eating habits. The curriculum is being delivered as part of Early Head Start home visits and compared to the effectiveness of usual practice Early Head Start home visits.
The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI\>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition.
In this study, one year changes in healthy eating and gardening behaviors associated with the intervention were estimated using a group randomized controlled trial design, with the comparison arm receiving a delayed intervention in the following school year.
This study, the Chickasaw Healthy Eating Environments Research Study (CHEERS), will be conducted in partnership with Chickasaw Nation. CHEERS comprises several mutually reinforcing strategies to improve blood pressure (BP) control in people with hypertension. Environmental strategies include the investigator's innovative "Packed Promise for a Healthy Heart" program that provides hypertensive adults ages 18 and older with a voucher for fresh vegetables and fruits (referred to as a "fresh check") and home delivered food boxes that contain Dietary Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and traditional healthy Chickasaw meals. The study facilitates demonstrations of healthy cooking practices in participating communities. At the individual level, tribal members with uncontrolled hypertension will receive heart-healthy recipes (available at getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture, educational materials, along with invitations to attend cooking demonstrations, fresh checks to improve access to fresh produce, and a Chickasaw Nation culturally-informed smartphone walking app called "AYA." At the policy level, CHEERS will culminate in a multimedia documentary presentation for tribal leadership detailing the intervention and featuring personal success stories by hypertensive community members. Study findings, including a health economics assessment, will be used to encourage policies for further expansion of the Packed Promise for a Healthy Heart Program; and policies promoting expansion of brick and mortar grocery outlets in rural Chickasaw communities.