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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00674518 |
This study will compare three methods of counseling to determine which is most effective at motivating participants to adopt healthy lifestyle habits.
The three methods are: individual counseling, working in groups with a health educator, and receiving advice from a physician. The health goals for subjects in this study are: 1) increase physical activity to 30 minutes each day, 2) reduce fat intake to less than 30% of total calories, 3) increase consumption of fruits and vegetables to at least 5 servings each day, and 4) reduce percentage of body fat to a healthy level.
Condition | Intervention |
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Obesity Physical Inactivity Diabetes |
Behavioral: One on one counseling Behavioral: Group/team - based health education Behavioral: PACE physician counseling |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Factorial Assignment, Efficacy Study |
Official Title: | Health Promotion Intervention: Sedentary Primary Care Patients |
Estimated Enrollment: | 100 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Counseling: Experimental
One-on-one sessions conducted by a professional motivational counselor to explore ways to help motivate participants to exercise, eat healthier, and lose weight.
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Behavioral: One on one counseling
Motivational Interviewing
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Group: Experimental
A nutrition and exercise specialist will lead and teach a group of 4 to 5 subjects in healthy nutrition, exercise and weight loss habits
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Behavioral: Group/team - based health education
peer led, scripted health promotion curriculum in groups of 4-5 individual, with team building activities and health education for 12, 1-hour sessions per year.
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MD Advice: Active Comparator
A physician will provide exercise and nutrition advice to participants immediately following testing
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Behavioral: PACE physician counseling
PACE format for physician exercise and nutrition counseling annually.
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The benefits of physical activity and proper nutrition have been well established to prevent and reduce the devastating effects of chronic illness including, cardiovascular disease, diabetes, and obesity. Unfortunately, nearly 80% of individuals fail to get enough exercise and eat a proper diet to alter these health disorders. In the United States, physicians do not routinely counsel patients about physical activity and nutrition. Although few studies have examined promotion of physical activity in the primary care setting, most have been disappointing. Achieving and maintaining healthy behaviors remain a major challenge to promoting health and caring for illness. This research proposals aims are to a) evaluate two health behavior change intervention strategies to improve physical activity and dietary behaviors among sedentary patients in a primary care office; and b) assess by cost-benefit analysis, the impact of each model intervention. After initial recruitment from OHSU Internal Medicine and Family Practice clinics, 105 sedentary patients will be randomly assigned to Model 1, Model 2, or Model 3. Model #1, a one-on-one, individualized counseling intervention known as Motivational Interviewing, based on the transtheoretical model of behavior change, will use twelve health educator counseling meetings and ten bi-weekly follow-up phone calls the first year and six 60-minute sessions will occur in the second year of the intervention. Model #2, a team-centered intervention where the health promotion curriculum is delivered by a group facilitator to a team of patients (based on the social influence theory) consists of twelve 60-minute peer facilitated group meetings and ten follow-up phone calls, with six sessions occurring the second year of the full outcome study. Group facilitators will be trained and use scripted lesson plans. Model #3, a usual practice control condition (5 minute physician advice using the Physician Advice Counseling Exercise or PACE format). Models 1 and 2 contact hours are the same. Year 01 is the pilot study to revise and refine the curriculum and study protocol. The full intervention will last two years while the behavior change durability will be assessed over another full year. The study's primary outcomes are increased physical activity as measured by peak oxygen uptake and survey, dietary changes assessed by intake survey, and body composition changes as measured by DEXA. Secondary outcome measures include blood pressure lipid and lipoprotein levels, biochemical markers of inflammation (CRP) and hormonal markers of obesity. Outcomes will be assessed using repeated measures design. Relationships among mediators, the intervention, and the outcome measures will be identified.
Ages Eligible for Study: | 30 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Examples are CAD, CHF, Recent CVA, poorly controlled DM (fasting glucose over 200 mg/dl), poorly controlled HTN, Severe COPD, Thyrotoxicosis, and Morbid Obesity with BMI > 40.
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Kerry S Kuehl, MD | Oregon Health and Science University |
Responsible Party: | Oregon Health & Science University ( Kerry Kuehl, MD DrPH ) |
Study ID Numbers: | 1-K23-RR017554-01A2 |
Study First Received: | May 6, 2008 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00674518 History of Changes |
Health Authority: | United States: Institutional Review Board |
Health Promotion Health Behavior Change Physical Activity |
Dietary Change Weight Loss Obesity |
Body Weight Signs and Symptoms Obesity Weight Loss Diabetes Mellitus |
Nutrition Disorders Overweight Overnutrition Healthy |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |