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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00569595 |
Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes. Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals. This exploratory project proposes to address this scientific gap by introducing and conducting a randomized controlled pilot of the Self-Care Stimulating Disease Prevention Program to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations.
Condition | Intervention | Phase |
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Diabetes Chronic Diseases |
Behavioral: Self-Care Stimulating Disease Prevention Program Behavioral: Fighting Cancer with Advice |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Improving Health Habits in Impoverished Populations |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Behavioral: Self-Care Stimulating Disease Prevention Program
The intervention is aimed at improving diet, increasing physical activity, and reducing sedentary behaviors among low-income patients, assuming that this will increase motivation and self-confidence to adhere to self-care regimens based on personal prioritizing and progressive goal setting.
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2: Sham Comparator
Patient health counseling program by lay health educators Entitled "Fighting Cancer with Advice."
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Behavioral: Fighting Cancer with Advice
Patient health counseling program by lay health educators entitled "Fighting Cancer with Advice."
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Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes. Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals. Few studies have examined the feasibility of using brief physician advice and multi-level, clinic-based interventions to change poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among these culturally diverse populations that comprise the clinic population. This exploratory project proposes to address this scientific gap by introducing and piloting a Self-Care Stimulating Disease Prevention Program (SCSDPP) to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations (primarily Latinos) served by the community clinics of the Venice Family Clinic (VFC) health center in Los Angeles County. The program will include the development of 1) a simple-to-use patient Health Priority Assessment (HPA) tool designed to assess patient preferences for behavior change; 2) a standard protocol for physicians to provide brief health advice using motivation interviewing (< 2 minutes per visit); 3) a protocol for distributing self-help aids for patient use (e.g., pedometer, exercise videos); and 4) a series of monthly follow-up counseling sessions by lay health educators (e.g., promotores) to help patients address their lifestyle change priorities over time. We will conduct a randomized controlled pilot of the SCSDPP in approximately 100 patient cases at two community health clinics within the VFC health center system. The pilot will utilize precise outcome measures, including commonly-accepted biomarkers (e.g., HgbA1c, fasting blood glucose) and psychometrically-validated measures of process and health status, to accurately assess the magnitude of changes in diet and physical activity among patients over a 12-month observation period. The feasibility of integrating the SCSDPP into the community health clinic setting will be evaluated, and is the primary aim of this project. The results will inform efforts to plan a larger, successor study. Relevance to Public Health: this study evaluates a clinic-based brief intervention to help prevent overweight/obesity, a public health problem that has been linked to the development of the metabolic syndrome and other precursors of diabetes.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Arangua, MPP | 310 794 6094 | larangua@mednet.ucla.edu |
United States, California | |
Queenscare Family Clinics | |
Los Angeles, California, United States, 90028 | |
UCLA Department of Family Medicine | |
Los Angeles, California, United States, 90024 |
Principal Investigator: | Lillian Gelberg, MD, MSPH | UCLA Department of Family Medicine |
Responsible Party: | UCLA Department of Family Medicine ( Lillian Gelberg, MD, MSPH, Professor & Vice Chair for Academic Affairs ) |
Study ID Numbers: | DK71065 |
Study First Received: | December 5, 2007 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00569595 |
Health Authority: | United States: Federal Government |
Prevention of Diabetes and other chronic diseases |
Diabetes Mellitus Chronic Disease |
Disease Attributes Pathologic Processes |