Completed Extramurally-Funded Grant and Contract Projects
Evaluation of WV’s Healthy Lifestyles Act (HB2816) Objective: This project conducted an evaluation of West Virginia’s childhood obesity legislation, which provided policy direction for schools in the areas of physical education, health education and assessment, fitness assessment, body mass index assessment, and the availability of vended beverages on campus. The comprehensive, multi-year evaluation was initiated in 2007 with funding from the Robert Wood Johnson Foundation, and continued through state and CDC support.
Evaluation of West Virginia’s Chronic Disease Programs Objective: This grant supported the evaluation of the implementation and impact of interventions to improve community health center care for diabetes, cardiovascular disease, and asthma patients throughout the state. Developed in partnership with the program staff in each disease program, the evaluations examined interventions to improve patient care through the use of electronic medical records and disease registries.
“Re-Mission: Patient Interviews and Knowledge Survey.” HopeLab Foundation. 2001. (Bradlyn, PI) Objective: To collect and analyze patient and health care provider data to serve as the foundation for development of an interactive videogame for adolescents and young adults with cancer. Quantitative and qualitative methods were used to identify key content for the development of the game.
“Health Related Quality of Life for Pediatric NF1 Patients.” Department of Defense. 2002-2007. (Bradlyn, PI; Award #: NF010064) Objective: To develop an NF1-specific health-related quality of life questionnaire for children. This questionnaire was based on information qualitative and quantitative information collected from patients, parents, teachers, and health care professionals.
“Health Promotion for WV Preschoolers and Parents.” Centers for Disease Control and Prevention. 2002-2005. (Harris, PI; Award #: H75/CCCH322130-01) Objective: To develop a culturally-sensitive, family-based health promotion program for preschool children and their families. This project was conducted in Headstart Centers and public preschool settings in four rural West Virginia counties.
“Improving Dyslipidemia Detection in Appalachian Families.” National Institutes of Health/National Heart, Lung, and Blood Institute. 2003-2007. (Harris, PI; Award #: 1R01-HL070120-01A1) Objective: To develop a community-tailored model to increase participation in a school-based cardiovascular screening program for 5th graders and their families. Qualitative and quantitative methods were used to design and evaluate the impact of this intervention. For More Information...
“Planning for the Evaluation of the Childhood Obesity Components of West Virginia’s House Bill 2816.” Robert Wood Johnson Foundation. 2007-2008. (Harris, PI) Objective: In preparation for the comprehensive statewide evaluation of the implementation and impact of WV House Bill 2816, this provided funding for method development and testing and collaboration with research teams from other states with similar projects.
“Evaluating Childhood Obesity Components of West Virginia House Bill 2816.” Robert Wood Johnson Foundation. 2007-2009. (Harris, Evaluation PI) Objective: To provide a comprehensive statewide evaluation of the implementation and impact of WV House Bill 2816 (“WV Health Lifestyles Act”). Data informing this multiyear, multimethod evaluation were collected from county school superintendents, school personnel, healthcare providers, and parents and students. Data from health education and fitness assessments were also included. For More information...
“West Virginia gDitty Pilot Study 1.0.” HopeLab Foundation. 2008. (Bradlyn, PI) Objective: To investigate the impact of accelerometry and social networking on middle school students’ moderate-to-vigorous physical activity. In this 8-week study, students wore accelerometers to measure MVPA and participated in an online community and reward program.
“West Virginia gDitty Pilot Study 1.5.” HopeLab Foundation. 2009. (Bradlyn, PI) Objective: To investigate the impact of accelerometry and social networking on middle school students’ moderate-to-vigorous physical activity. In this 12-week study, students wore accelerometers to measure MVPA and participated in an online community and reward program.
“Evaluation of Policy 4321.1 (WV Standards for Child Nutrition).” WV Office of Child Nutrition/Department of Education. 2009. (Harris, PI) Objective: To provide an evaluation of the implementation and impact of the new West Virginia Standards for School Nutrition. Data were collected from county school superintendents, county food service directors, school personnel, and parents and students.
Additional Completed Research Projects “BMI-Based Body Size Guides for Women and Men”. 2005-2008. (Harris, PI) Harris, CV, Bradlyn, AS, Coffman, J, Gunel, E, & Cottrell, L. (2008). BMI-based Body Size Guides for Women and Men: Development and Validation of a Novel Pictorial Method to Assess Weight-related Concepts. International Journal of Obesity, 32, 336-342. Objective: BMI-based instruments were developed and evaluated to determine perceptions of weight status, particularly of overweight and obesity, using pictorial images of women and men.

Completed Extramurally-Funded Grant and Contract Projects

Evaluation of WV’s Healthy Lifestyles Act (HB2816)

Objective: This project conducted an evaluation of West Virginia’s childhood obesity legislation, which provided policy direction for schools in the areas of physical education, health education and assessment, fitness assessment, body mass index assessment, and the availability of vended beverages on campus. The comprehensive, multi-year evaluation was initiated in 2007 with funding from the Robert Wood Johnson Foundation, and continued through state and CDC support.

Evaluation of West Virginia’s Chronic Disease Programs

Objective: This grant supported the evaluation of the implementation and impact of interventions to improve community health center care for diabetes, cardiovascular disease, and asthma patients throughout the state. Developed in partnership with the program staff in each disease program, the evaluations examined interventions to improve patient care through the use of electronic medical records and disease registries.

“Re-Mission: Patient Interviews and Knowledge Survey.” HopeLab Foundation. 2001. (Bradlyn, PI)

Objective: To collect and analyze patient and health care provider data to serve as the foundation for development of an interactive videogame for adolescents and young adults with cancer. Quantitative and qualitative methods were used to identify key content for the development of the game.

“Health Related Quality of Life for Pediatric NF1 Patients.” Department of Defense. 2002-2007. (Bradlyn, PI; Award #: NF010064)

Objective: To develop an NF1-specific health-related quality of life questionnaire for children. This questionnaire was based on information qualitative and quantitative information collected from patients, parents, teachers, and health care professionals.

“Health Promotion for WV Preschoolers and Parents.” Centers for Disease Control and Prevention. 2002-2005. (Harris, PI; Award #: H75/CCCH322130-01)

Objective: To develop a culturally-sensitive, family-based health promotion program for preschool children and their families. This project was conducted in Headstart Centers and public preschool settings in four rural West Virginia counties.

“Improving Dyslipidemia Detection in Appalachian Families.” National Institutes of Health/National Heart, Lung, and Blood Institute. 2003-2007. (Harris, PI; Award #: 1R01-HL070120-01A1)

Objective: To develop a community-tailored model to increase participation in a school-based cardiovascular screening program for 5th graders and their families. Qualitative and quantitative methods were used to design and evaluate the impact of this intervention.

For More Information...

“Planning for the Evaluation of the Childhood Obesity Components of West Virginia’s House Bill 2816.” Robert Wood Johnson Foundation. 2007-2008. (Harris, PI)

Objective: In preparation for the comprehensive statewide evaluation of the implementation and impact of WV House Bill 2816, this provided funding for method development and testing and collaboration with research teams from other states with similar projects.

“Evaluating Childhood Obesity Components of West Virginia House Bill 2816.” Robert Wood Johnson Foundation. 2007-2009. (Harris, Evaluation PI)

Objective: To provide a comprehensive statewide evaluation of the implementation and impact of WV House Bill 2816 (“WV Health Lifestyles Act”). Data informing this multiyear, multimethod evaluation were collected from county school superintendents, school personnel, healthcare providers, and parents and students. Data from health education and fitness assessments were also included.

For More information...

“West Virginia gDitty Pilot Study 1.0.” HopeLab Foundation. 2008. (Bradlyn, PI)

Objective: To investigate the impact of accelerometry and social networking on middle school students’ moderate-to-vigorous physical activity. In this 8-week study, students wore accelerometers to measure MVPA and participated in an online community and reward program.

“West Virginia gDitty Pilot Study 1.5.” HopeLab Foundation. 2009. (Bradlyn, PI)

Objective: To investigate the impact of accelerometry and social networking on middle school students’ moderate-to-vigorous physical activity. In this 12-week study, students wore accelerometers to measure MVPA and participated in an online community and reward program.

“Evaluation of Policy 4321.1 (WV Standards for Child Nutrition).” WV Office of Child Nutrition/Department of Education. 2009. (Harris, PI)

Objective: To provide an evaluation of the implementation and impact of the new West Virginia Standards for School Nutrition. Data were collected from county school superintendents, county food service directors, school personnel, and parents and students.

Additional Completed Research Projects “BMI-Based Body Size Guides for Women and Men”. 2005-2008. (Harris, PI)

Harris, CV, Bradlyn, AS, Coffman, J, Gunel, E, & Cottrell, L. (2008). BMI-based Body Size Guides for Women and Men: Development and Validation of a Novel Pictorial Method to Assess Weight-related Concepts. International Journal of Obesity, 32, 336-342.

Objective: BMI-based instruments were developed and evaluated to determine perceptions of weight status, particularly of overweight and obesity, using pictorial images of women and men.

Completed Industry-Sponsored Clinical Trials

Obesity, Metabolic Syndrome, Cardiovascular & Diabetes Clinical Trials

A Randomized, Double-blind, Two-arm, Placebo-controlled, Parallel-group, Multicenter Study of Rimonabant 20 mg Once Daily in the Treatment of Atherogenic Dyslipidemia in Abdominally Obese Patients. (Sanofi-Aventis)

Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients with Clustering Risk Factors. (Sanofi-Aventis)

A 1-Year, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to evaluate the Efficacy and Safety of CP-945,598 in the Treatment of Overweight, Oral Agent Treated Subjects with Type 2 Diabetes Mellitus. (Pfizer)

A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of CP-945,598 in the Treatment of Obese Subjects. (Pfizer)

Central Nervous System (Psychiatric) Clinical Trials

A Multicenter, Long-Term, Open-Label Study to Assess the Safety and Tolerability of Aripiprazole as Adjunctive Therapy in the Treatment of Outpatients with Major Depressive Disorder. (Bristol-Myers Squibb)

Evaluation of 24 Hour Motor Activity of Buproprion XL vs Placebo in Patients with Major Depressive Disorder. (Glaxo Wellcome and Campbell University)

A Multi-Center, Double-blind, Randomized-withdrawal, Parallel-group, Placebo-controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release as Monotherapy in the Maintenance Treatment of Patients with Major Depressive Disorder Following an Open-Label Stabilization Period. (AstraZeneca)

A Multicenter, Double-blind, Study on the Efficacy and Safety of Aripiprazole in Combination with Lamotrigine in the Long-term maintenance Treatment of Patients with Bipolar I Disorder with a Recent Manic or Mixed Episode. (Bristol-Myers Squibb)

An 8-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-controlled (Escitalopram Oxalate 10mg) Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel) 150 mg/day and 300 mg/day Compared with Placebo in the Treatment of Generalized Anxiety Disorder. (AstraZeneca)

A 6-week Multicenter, Double-Blind, Randomized, Parallel-group, Placebo-controlled and Active-controlled (Duloxetine 60 mg/day) Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) 150 mg/day and 300 mg/day as monotherapy in the Treatment of Patients with Major Depressive Disorder. (AstraZeneca)

Bradlyn, AS (Investigator). A Multicenter, Randomized, 8-week Double-Blind Acute Phase Followed by a 6-month Continuation Phase (Open-Label or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women with Major Depressive Disorder. (Wyeth Research)

Cystic Fibrosis Clinical Trials

Quality of Life in Cystic Fibrosis: Evaluation of Status Associated with Pentoxifylline Treatment. (Hoechst Roussel Pharmaceuticals)

Quality of Life Associated with MEP IGIV Therapy in Cystic Fibrosis Patients: A Randomized, Multi-Center, Double-Blind, Placebo – Controlled Trial. (Univax Biologics)

Quality of Life Associated with a Rising Dose Tolerance Study of Multiple Daily Doses of Uridine 5’ Triphosphate in Pediatric Patients with Cystic Fibrosis Lung Disease. (Inspire Pharmaceuticals)

Quality of Life Associated with a Phase IIa Multiple Dose Study to Evaluate the Lung-Specific Bioefficacy of Oral Administration with DMP 777 in Adult Patients with Cystic Fibrosis. (DuPont Merck Pharmaceutical Company)

Harris, C.V. (Principal Investigator). Validation of an Outcomes Monitoring Tool to Assess Airway Clearance Techniques in Cystic Fibrosis. (American Biosystems)

Study Physicians
James Stevenson, MD	Daniel Elswick, MD	Chris Kincaid, MD
Joe Selby, MD

Projects / Miscellaneous
“Jamie Oliver’s Food Revolution in West Virginia: Initial Evaluation of School-based Meal Changes” To evaluate the acceptability and impact of the Food Revolution program in Central City Elementary School.