Improving Health Habits in Impoverished Populations

NCT ID: NCT00569595

Last Updated: 2011-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetes; Chronic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Multi-Level, Patient-Directed, Lifestyle Change, Health Promotion Program

Group Type: EXPERIMENTAL

Self-Care Stimulating Disease Prevention Program

Intervention Type: BEHAVIORAL

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.

2

Patient health counseling program by lay health educators Entitled "Fighting Cancer with Advice."

Group Type: SHAM_COMPARATOR

Fighting Cancer with Advice

Intervention Type: BEHAVIORAL

Patient health counseling program by lay health educators entitled "Fighting Cancer with Advice."

Interventions

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.

Intervention Type: BEHAVIORAL

Fighting Cancer with Advice

Patient health counseling program by lay health educators entitled "Fighting Cancer with Advice."

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ages 18 and older
• English or Spanish-speaking
• Accessible by telephone or in person over time
• Willing to cooperate with data collection
• Planning to be in the Los Angeles area for the next 6 to 12 months so they can complete the study period

Exclusion Criteria

• Women who are pregnant
• History of cancer, except non-melanoma skin cancer or in situ cancers
• Medical conditions preventing free choice of foods (e.g., colitis, poorly-controlled diabetes)
• Medical conditions precluding participation in common forms of aerobic or resistance exercise (e.g., uncontrolled angina, asthma or hypertension; severe physical impairment; and end-stage disease conditions such as congestive heart failure, nephropathy from any cause, or advanced chronic pulmonary disease)
• Does not show any desire to change any of their health behaviors (i.e., healthy eating, physical activity, sedentary behavior, or control their weight)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

UCLA Department of Family Medicine

Principal Investigators

Lillian Gelberg, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

UCLA Department of Family Medicine

Locations

UCLA Department of Family Medicine

Los Angeles, California, United States

Queenscare Family Clinics

Los Angeles, California, United States

Countries

United States

Other Identifiers

R21DK071065

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21 DK71065 (completed)

Identifier Type: -

Identifier Source: org_study_id