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Improving Health Habits in Impoverished Populations

Primary Purpose

Diabetes, Chronic Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Self-Care Stimulating Disease Prevention Program
Fighting Cancer with Advice
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Prevention of Diabetes and other chronic diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • UCLA Department of Family Medicine
  • Queenscare Family Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum glycosylated hemoglobin, heart rate recovery step test

Secondary Outcome Measures

Total Cholesterol, BMI, waist circumference, healthy eating, physical activity, perceived health status, patient satisfaction, mood

Full Information

First Posted
December 5, 2007
Last Updated
June 6, 2011
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00569595
Brief Title
Improving Health Habits in Impoverished Populations
Official Title
Improving Health Habits in Impoverished Populations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Chronic Diseases
Keywords
Prevention of Diabetes and other chronic diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Multi-Level, Patient-Directed, Lifestyle Change, Health Promotion Program
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Patient health counseling program by lay health educators Entitled "Fighting Cancer with Advice."
Intervention Type
Behavioral
Intervention Name(s)
Self-Care Stimulating Disease Prevention Program
Intervention Description
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
Intervention Name(s)
Fighting Cancer with Advice
Intervention Description
Patient health counseling program by lay health educators entitled "Fighting Cancer with Advice."
Primary Outcome Measure Information:
Title
Serum glycosylated hemoglobin, heart rate recovery step test
Time Frame
4 and 6 months
Secondary Outcome Measure Information:
Title
Total Cholesterol, BMI, waist circumference, healthy eating, physical activity, perceived health status, patient satisfaction, mood
Time Frame
4 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lillian Gelberg, MD, MSPH
Organizational Affiliation
UCLA Department of Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Department of Family Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Queenscare Family Clinics
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States

12. IPD Sharing Statement

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Improving Health Habits in Impoverished Populations

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