Improving Health Habits in Impoverished Populations

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00569595
First received: December 5, 2007
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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
Diabetes
Chronic Diseases
Behavioral: Self-Care Stimulating Disease Prevention Program
Behavioral: Fighting Cancer with Advice
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Health Habits in Impoverished Populations

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Serum glycosylated hemoglobin, heart rate recovery step test [ Time Frame: 4 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Cholesterol, BMI, waist circumference, healthy eating, physical activity, perceived health status, patient satisfaction, mood [ Time Frame: 4 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Multi-Level, Patient-Directed, Lifestyle Change, Health Promotion Program
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.
Sham Comparator: 2
Patient health counseling program by lay health educators Entitled "Fighting Cancer with Advice."
Behavioral: Fighting Cancer with Advice
Patient health counseling program by lay health educators entitled "Fighting Cancer with Advice."

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569595

Locations
United States, California
Queenscare Family Clinics
Los Angeles, California, United States, 90028
UCLA Department of Family Medicine
Los Angeles, California, United States, 90024
Sponsors and Collaborators
Investigators
Principal Investigator: Lillian Gelberg, MD, MSPH UCLA Department of Family Medicine
  More Information

No publications provided

Responsible Party: Lillian Gelberg, MD, MSPH, Professor of Family Medicine & Public Health, UCLA Department of Family Medicine
ClinicalTrials.gov Identifier: NCT00569595     History of Changes
Other Study ID Numbers: R21 DK71065 (completed)
Study First Received: December 5, 2007
Last Updated: June 6, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Prevention of Diabetes and other chronic diseases

Additional relevant MeSH terms:
Chronic Disease
Diabetes Mellitus
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014