Treatment Trials

33 Clinical Trials for Various Conditions

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COMPLETED
THIS-WIC Vermont Breastfeeding Education Application Feasibility Study
Description

With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the Vermont WIC department will be conducting a feasibility study of a mobile telehealth solution for breastfeeding education. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys and interviews. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on WIC participant through the WIC management information system (MIS) and the telehealth platform. It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with breastfeeding education.

COMPLETED
South Carolina WIC Telehealth Solution
Description

With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the South Carolina WIC department will be implementing a telehealth solution for nutrition and breastfeeding support. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on the WIC participant through the WIC management information system (MIS). It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with nutrition and breastfeeding support while also reducing the burden of attending in-person care.

COMPLETED
THIS-WIC Telehealth Solutions: Evaluation With North Carolina WIC Clients
Description

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, North Carolina (NC) WIC department will be implementing new, nutrition education telehealth in NC's WIC program. The purpose of this study is to evaluate the impact of the telehealth platform. The evaluation will focus on NC WIC clients as the study population. The North Carolina WIC department would be implementing this education platform, regardless of the evaluation research. The North Carolina WIC department is responsible for implementing this new intervention, while the Tufts University research team is responsible for the evaluation of this platform through surveys and analysis of administrative data. An online survey will be used to gauge WIC clients' satisfaction with the telehealth solution and the impact of the telehealth solution compared to usual care on breastfeed duration, dietary intake, attendance at scheduled appointments, attitudes to breastfeeding and nutrition education, and barriers encountered. Survey data will be combined with previously collected data on clients and their families from the NC Management Information Systems (MIS), and aggregate level data from the telehealth solution about utilization.

COMPLETED
Georgia: Technology and WIC - A Comprehensive Approach to Public Health
Description

With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the Georgia WIC department will be implementing a telehealth solution for nutrition and breastfeeding support. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on the WIC participant through the WIC management information system (MIS). It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with nutrition and breastfeeding support while also reducing the burden of attending in-person care.

COMPLETED
Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan
Description

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC), Michigan's (MI) WIC department will pilot telehealth opportunities as a means of delivering services to WIC Clients. This video conferencing pilot looks to improve and/or remove barriers. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations. The purpose of this study will be to evaluate the effectiveness of this telehealth solution.

COMPLETED
Evaluating Telehealth Solutions in WIC: Wisconsin WIC Clients
Description

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, Wisconsin's (WI) WIC department will be implementing a new, customized, mobile-friendly nutrition education platform called ONE (Online Nutrition Education) in WI's WIC program. The purpose of this study is to evaluate the impact of the ONE platform. The evaluation will focus on WIC clients as the study population. The Wisconsin WIC department would be implementing this education platform, regardless of the evaluation research. The Wisconsin WIC department is responsible for implementing this new intervention, while the Tufts University research team is responsible for the evaluation of this platform through surveys and analysis of administrative data. An online survey will be used to gauge WIC clients' satisfaction with ONE, and the impact of the telehealth solution compared to usual care on breastfeed duration, dietary intake, attendance at scheduled appointments, attitudes to breastfeeding and nutrition education, and barriers encountered. Survey data will be combined with previously collected data on clients and their families from the WI Management Information Systems (MIS), and aggregate level data from the ONE telehealth solution about ONE utilization.

COMPLETED
Prevention of Postpartum Weight Retention in Low Income WIC Women
Description

This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.

Conditions
RECRUITING
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
Description

The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.

COMPLETED
Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership
Description

Pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families.

COMPLETED
Living Well With Serious Illness "Wicokuje Sica Tuha Akisniya Wiconi": Wawokiya Health Advocate Intervention
Description

Informed by a Community Advisory Board (CAB) and community assessments performed in the first phase of work funded through R01CA240080, this study will test a wawokiya (one who helps) health advocate (WHA)-based palliative care intervention that aims to improve the wellbeing of patients with cancer. In alignment with community guidance, patients will be allocated to an intervention arm or a waitlist arm as dictated by capacity. For those patients receiving the intervention, palliative care trained WHAs will perform regular home visits to assess the needs of patients seriously ill with cancer (as defined by a referring provider) and their caregivers, and work to address those needs using their training and identified community resources. The frequency of visits / calls will be determined based on level of need. The specific aims are listed below. Specific Aim 1: To examine the impact of a wawokiya health advocate (WHA) palliative care intervention on patient health outcomes including quality of life, symptom burden, and psychosocial wellbeing. H1: Compared to patients in the waitlist group, patients enrolled in the WHA intervention will have a better quality of life, greater psychosocial wellbeing, and lower symptom burden. Specific Aim 2: To assess the impact of a WHA palliative care intervention on patient healthcare utilization including emergency room visits, hospitalizations, telehealth visits, and concordance of services with goals of care. H2: Patients enrolled in the WHA intervention will have fewer ER visits and hospitalizations and a greater number of telehealth visits than patients enrolled in the waitlist group. H3: A greater proportion of patients enrolled in the WHA intervention will die in their preferred location. Specific Aim 3: To examine the impact of a WHA palliative care intervention on caregiver outcomes including coping, caregiver burden, and quality of life. H4: Compared to caregivers in the waitlist group, caregivers enrolled in the WHA intervention will have a better quality of life, better coping, and decreased caregiver burden. Specific Aim 4: To explore moderators and mediators of a WHA as a palliative care navigator on rural reservations in South Dakota. H5: Adherence to protocols will moderate the effectiveness of a WHA as a PC navigator. .

Conditions
COMPLETED
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC
Description

The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on gestational weight gain (GWG) in a low-income population.

TERMINATED
Integrating WIC With Early Childhood Systems of Developmental Care
Description

This study's goals are to improve connections between Oregon Women, Infants, \& Children (WIC) clinics, primary care providers, and Early Intervention/Early Childhood Special Education programs (EI/ECSE), in order to help children with suspected developmental delays get the services they need.

COMPLETED
WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers
Description

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.

COMPLETED
A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy
Description

The study will test the effectiveness of a smartphone-based behavior modification program adapted for use in Women, Infants, and Children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the Louisiana Women, Infants, and Children program.

COMPLETED
Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
Description

The purpose of this study is to determine the effect of an antenatal obesity treatment on gestational weight gain when integrated into Philadelphia WIC.

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
Developing a Preschool Obesity Intervention for Families Enrolled in WIC
Description

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a community and home-based preschool obesity intervention for families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

COMPLETED
Trial of Fresh Start Weight Loss Intervention in WIC Participants
Description

The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.

Conditions
COMPLETED
Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM)
Description

Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children. The intervention group's weight change (difference between the initial enrollment and 3 months post intervention) will differ from the control group's weight change by an average of at least 2.8 pounds.

WITHDRAWN
Wick vs. No Wick: Does Method of Closure Affect Rate of Wound Infection?
Description

Countless children undergo surgery annually for management of what clinicians consider to be a "dirty wound". One frequently encountered example is the ostomy reversal. During this planned operation, the previously diverted small bowel or colon is reconnected with the distal intestine, restoring continuity. However, this procedure leaves an open wound on the anterior abdominal wall, creating a conundrum for the surgeon and raises the question: how should the wound be managed? In the investigators practice at CHOA, surgeons utilize both a wick and a non-wicked wound dressing. In this prospective randomized trial, we wish to evaluate these two dressings in children receiving an ostomy closure. The investigators hypothesis is that the incidence of wound infection after ostomy reversal is the same regardless of if a wick is placed or not.

COMPLETED
Abscess Packing Versus Wick Placement After Incision and Drainage
Description

Abscesses or "boils" are becoming more common every year and are a common reason children come to the Emergency Department. For the abscess to heal the skin needs to be opened to let the pus come out. Often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. It is not known if the type of "packing" that is done is necessary or if a more simple treatment is as good or better. With informed consent we randomly place a child into one (1) of two (2) groups in this study that will say if the child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece) of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment in the emergency department the child will be scheduled to follow-up in the Pediatric Acute Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this visit the healing of the wound will be checked by the staff in the clinic and will be scored. With this evaluation of the wound the hypothesis that for a simple superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of traditional gauze packing.

COMPLETED
A Pilot Study of Diabetes Risk Reduction Program With WIC Mothers(The Special Supplemental Nutrition Program for Women, Infants, and Children) Overweight WIC Mothers
Description

1) to evaluate treatment fidelity of DRRP: study design, training of interventionists, delivery and receipt of the intervention, and application of the intervention in real-life settings; 2) to identify successful strategies for participant recruitment and maintaining active participation; 3) to collect and analyze preliminary indicators of DRRP's effect on dietary intake, physical activity, stress responses, and body weight; and 4) To evaluate sample representativeness of the target audience, implementation and acceptability of DRRP, and attrition rate.

COMPLETED
Fresh Start: Increasing Early Produce Intake
Description

Nearly 22% of children in Philadelphia live in food-insecure (FI) households, often leading to reliance on inexpensive, nutrient-poor foods and associated poor health outcomes. Despite this, utilization of food benefit programs is often low, including the Special Supplemental Nutrition Program Women, Infants, and Children (WIC) Farmer's Market Nutrition Program (FMNP). In the prior qualitative study, Investigators found that parents desire to increase their children's intake of produce but face many barriers to produce access; caregivers described a preference for delivery-based, low-or-no cost food programs to increase produce access and intake among children. This pilot trial seeks to assess the effectiveness of a short-term, tiered-fee produce delivery program in retaining participants and increasing produce access and intake among families with WIC-eligible children

Conditions
RECRUITING
Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
Description

This project will increase knowledge about how a simple intervention, grocery delivery, impacts weight gain and diet among low-income pregnant young women. Results can then be used to support other pregnant young women.

ACTIVE_NOT_RECRUITING
Social Media and Risk Reduction Teaching-Enhanced Reach
Description

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).

ACTIVE_NOT_RECRUITING
BOOST: Breastfeeding Onset and Onward With Support Tools
Description

This behavioral intervention trial will test whether a standard care breastfeeding intervention from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program plus monthly financial incentives contingent on observed breastfeeding will improve breastfeeding duration among low-income mothers compared to a standard (WIC) care control. Investigators hypothesize that the standard care plus monthly contingent financial incentives intervention will promote longer breastfeeding duration, fewer infant health issues, and greater healthcare cost savings than the standard care (control) intervention.

COMPLETED
Prenatal Education Video Study
Description

A randomized, controlled trial will be conducted during which pregnant women will be randomized to receive the intervention - viewing a prenatal education video about how to breastfeed an infant - or the sham intervention - viewing a prenatal education video about maternal nutrition and physical activity during pregnancy. Participants will be interviewed via telephone at one, three, and six months post-partum to determine how they feed their infants at each of these time frames.

Conditions
COMPLETED
Fit Moms- an Internet-based Postpartum Weight Loss Program
Description

The purpose of this study is to provide weight loss interventions for Mothers participating in the WIC program, using the internet to deliver weight loss materials.

ACTIVE_NOT_RECRUITING
GrowWell - Responsive Bottle Feeding
Description

The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads.

Conditions
COMPLETED
Maternal Health Diabetes Prevention Study
Description

The aim of this project is to use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to collect pilot data on the implementation of a Diabetes Prevention Program-like intervention in the Women, Infants, and Children (WIC) program.