Active Studies | Upcoming Studies | In Analysis
Active Studies
Greenlight Plus
The Greenlight Plus study is an obesity prevention randomized controlled trial that gives educational training to parents at well child checks from birth to 24 months, either with (“plus”) or without an additional text messaging digital intervention. Part of the study includes training residents and equipping them with helpful tools to use with parents. Approximately 125 English- and Spanish-speaking families were enrolled, follow-up is ongoing with survey measures collected at 10 timepoints from birth through 24 months.
PI: Dr. Charles Wood, Co-I: Dr. Melissa Kay
Sponsor: PCORI
Positive Outliers in Childhood Obesity
This study enrolled 80 English- and Spanish-speaking caregivers Black and Hispanic/Latino youth age 5-13 living in areas in Durham with a high risk of childhood obesity, and aims look at differences in family behaviors and characteristics between children at a healthy weight and children who have overweight or obesity. The first phase consisting of survey data collection is complete, the second phase of qualitative interviews with parents to explore topics of health, lifestyle, and thoughts about the neighborhood in more depth is ongoing.
PI: Dr. Michelle White, Co-I: Dr. Naomi Duke
Sponsor: Duke CTSA (KL2)
Active Dads Healthy Families
This study aims to evaluate the feasibility of implementing a physical activity program delivered by Durham Parks & Recreation for fathers and their children’s ages 2-5 years. Fathers were surveyed throughout the program, and fathers and children wore Actigraph accelerometers for 7 days prior to starting the program and at the end of the program to collect activity. The study team also conducted systematic observation of sessions to assess engagement and objectively examine activities in the sessions. Two cohorts have completed assessment.
PI: Dr. Cody Neshteruk
Sponsor: The Duke Endowment
Going Places
This study aims to evaluate the feasibility of implementing a transportation equity toolkit for youth organizations to improve physical activity participation and access to recreation among underrepresented adolescents. This study has been codeveloped with Durham Parks & Recreation. Participants are recruited from the MyDurham teen afterschool program led by Durham Parks & Recreation staff. Teens complete baseline physical activity and self-efficacy surveys, participate in twice-per-week transportation equity workshops, and wear Garmin accelerometers for 7 days at baseline and follow-up. Parents, teens and staff also participate in focus groups to understand barriers to physical activity participation and recreation program access in Durham, NC. The study is currently expanding to include walking groups, field trips incorporating photovoice, mapping, digital storytelling, and family events.
PI: Dr. Emily D’Agostino
Sponsor: Internally funded
Parks and Pediatrics Fit Together
This is a hybrid study to evaluate implementation as well as patient-level outcomes of the clinic-community partnership model for pediatric obesity treatment interventions. Patients will be enrolled from partnering clinics in Charlotte and Winston-Salem, and those in the intervention group will have the opportunity to attend Fit Together activity sessions hosted at their local Parks & Recreation center. Parents and children will complete surveys throughout the 12 month study period; wear Garmin activity monitors; attend Fit Together sessions; and have access to a Fit Together app for attendance tracking, educational materials, and social incentives. Clinical and community stakeholders/partners will complete surveys and interviews about preparation for and implementation of the program. Early implementation is ongoing, patient enrollment anticipated to begin Fall 2022.
PI: Dr. Asheley Skinner, Dr. Sarah Armstrong
Sponsor: National Institutes of Health (NICHD, R01)
Clinical and Community Data Initiative for the NC Triangle Region (CODI)
CODI@NC is a multi-site, community-engaged data science project, with a primary aim to create a privacy-protected longitudinal data set that links the health records of children aged 2-18 years of age from Duke, UNC, and federally-qualified health centers with community-level data from multiple community partner agencies including the YMCA, Parks and Recreation, WIC, Department of Public Health, the Coalition to End Homelessness, and others. Children are linked at the household level, allowing comparisons between child and parent health outcomes to be associated with local and neighborhood-level interventions. The ultimate goal is for CODI to be a national resource for epidemiologic monitoring of the community-level factors that most influence health outcomes over time.
PIs: Drs. Asheley Skinner, Sarah Armstrong, and Charles Wood
Sponsor: Centers for Disease Control and Prevention
iPop-Up
The overall aim of this study is to develop an EHR-based clinical decision support tool to optimize obesity treatment in primary care. To do this, primary care providers are being surveyed and interviewed to understand more about current obesity management and counseling in their practices. There is also a retrospective analysis to examine the baseline status of obesity management in primary care. Once developed, there will be a pilot of the clinical decision tool among select practices. This is a multi-site collaboration, led by Yale University.
PI: Dr. Charles Wood
Sponsor: National Institutes of Health (NIMHD, R01)
Predictors of Youth Obesity Treatment Success
The goal of this study is to address disparities in youth obesity and improve cardiometabolic health by furthering our understanding of the specific factors that influence obesity treatment. To do this, we are using over nine years of electronic health record data from Duke Children’s Healthy Lifestyles clinic to longitudinally identify individual, family, and neighborhood level predictors of children and adolescent’s change in weight as well as cardiovascular health indicators including blood pressure, blood lipids, and fitness.
PI: Dr. Cody Neshteruk
Sponsor: The Obesity Society and American Heart Association
Healthy Roots
This project uses digital technologies to improve diet quality among parents and caregivers receiving nutrition benefits from the Special Supplemental Nutrition Assistance Program for Women, Infants and Children (WIC).
PI: Dr. Melissa Kay
Sponsor: Duke REACH Equity Career Development Award
Upcoming Studies
BREATHE Fit
The goal of this study is to examine whether inspiratory muscle rehabilitation (IMR) is an acceptable add-on intervention in children with obesity, ages 8 to 17 years old. Enrollment anticipated to begin May 2022.
PI: Dr. Jason Lang
Sponsor: Derfner Foundation
Appetite and Body Composition in Infants
This study aims to examine associations between early infant growth patterns and appetite over the first 6 months of life, in the context of obesity risk. Enrollment anticipated to begin May 2022.
PI: Dr. Charles Wood
Sponsor: Derfner Foundation
Healthy Roots
The goal of this study is to pilot the delivery of an evidence-based digital intervention providing supplemental feeding support to women enrolled in a nutrition assistance program (WIC). The first phase of intervention development, including interviews with stakeholders and initial digital platform development, is anticipated to begin May 2022.
PI: Dr. Melissa Kay
Sponsor: Duke CTSA (KL2)
Interactions Study
This study aims to examine social support, social networking, and neighborhood engagement among primary caregivers of Black and Hispanic/Latino children ages 2 to 4. Enrollment anticipated to begin Fall 2022.
PI: Dr. Michelle White
Sponsor: Duke Population Research Institute (NICHD P2C Population Dynamics Centers Research Infratructure Program)
Support from the Start
This project aims to reduce risk for rapid infant weight gain using a digital intervention focused on responsive feeding among mothers receiving benefits from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Enrollment anticipated to begin May 2022
PI: Dr. Melissa Kay
Sponsor: Duke CTSA (KL2)
Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep Regularity and Psychiatric Health in Adolescents
The SHEETS study seeks to test the feasibility and acceptability of a digital sleep regularity intervention for adolescents.
PI: Drs. Naomi Duke and Jessica Lunsford-Avery
Sponsor: National Institutes of Health (NIMH, R34)
In Analysis
Childhood Obesity Microbiome (CHOICE) Study
The CHOICE Study recruited approximately 40 children age 6 to 11 with obesity to examine the effectiveness of a microbiome diet on dietary quality and microbiome composition using direct purchase of groceries and nutritional counseling, versus nutritional counseling only. Families completed surveys and provided stool samples throughout the study, and completed an interview to discuss their microbiome report at completion of the study.
PI: Dr. Sarah Armstrong
Sponsor: Duke Microbiome Center
Healthy Lifestyles Food Pantry
This study aimed to examine the Healthy Lifestyles clinic’s standard of care food insecurity screening along with the use of its new in-clinic food pantry. All patients complete a 2-item food insecurity screen and are asked if they would like a bag of healthy, non-perishable foods to take home with them (irrespective of response to the screener). Parents were approached to complete a survey with additional food insecurity questions, as well as questions about food use, stress, and reasons for declining or accepting food. Individuals who accepted food were given a second survey at 1-month to further assess food use and impact. Participants were also invited to participate in an interview exploring these themes more in depth.
PI: Dr. Sarah Armstrong
Sponsor: McClay Foundation
Assets for Health
Assets for Health sought to understand how community organizations and parents would like to approach sharing/learning about various health-related activities in their area by conducting qualitative focus groups and interviews. Participants were also asked how they have adapted to COVID-19 in relation to seeking out or offering activities.
PI: Dr. Michelle White
Sponsor: Duke CTSA (KL2)
AHA Strategically Focused Research Network Pediatric Obesity Center Projects
This AHA grant includes 3 projects:
- Hearts & Parks clinical project enrolled ~350 participants ages 5 to 17 years old with a BMI > 95th percentile from 3 pediatric primary care clinics in Durham (DCPC Roxboro St., Durham Pediatrics, and Regional Pediatrics) for a randomized clinical trial examining the impact of a pediatric weight management intervention at the Healthy Lifestyles clinic and attendance to Bull City Fit activity sessions. Healthy weight control children (n=50) were also recruited. Participants completed survey measures and provided blood and stool samples; clinical data was also recorded from the medical record
- Basic project looking at the microbiome and metabolomics of enrolled children, using blood and stool samples
- Population project looking at the Healthy Lifestyles patient population clinical dataset
PIs: Drs. Sarah Armstrong, Asheley Skinner, Jennifer Li, and Svati Shah
Sponsor: American Heart Association
POMMS Study
The Pediatric Obesity Microbiome & Metabolism Study (POMMS) studied the microbiome of children with obesity while undergoing weight loss treatment at Healthy Lifestyles. Participants completed surveys and provided stool samples. They also completed interviews to discuss their microbiome analysis reports.
PI: Dr. Sarah Armstrong
Sponsor: NIH (NIDDK, R24)
