Improving Health Habits in Impoverished Populations

NCT00569595 | Completed Phase 3

• 2 other identifiers: R21 DK71065 (completed)R21DK071065
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes; Chronic Diseases

Keywords

Prevention of Diabetes and other chronic diseases

Outcome Measures

Primary Outcomes (1)

• Serum glycosylated hemoglobin, heart rate recovery step test

  4 and 6 months

Secondary Outcomes (1)

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

  4 and 6 months

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Self-Care Stimulating Disease Prevention Program

2

SHAM COMPARATOR

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

Behavioral: Fighting Cancer with Advice

Interventions

Self-Care Stimulating Disease Prevention Program 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.

1

Fighting Cancer with Advice BEHAVIORAL

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (2)

UCLA Department of Family Medicine

Los Angeles, California, 90024, United States

Location

Queenscare Family Clinics

Los Angeles, California, 90028, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease

Interventions

Counseling

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lillian Gelberg, MD, MSPH

  UCLA Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 7, 2007
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

US (2)