Changing Healthy Outcomes In Clinic Environments
Condition: Obesity; Physical Inactivity; Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): One on one counseling; Group/team - based health education; PACE physician counseling
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Motivational Interviewing; 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.; PACE format for physician exercise and nutrition counseling annually.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Health Promotion; Health Behavior Change; Physical Activity; Dietary Change; Weight Loss; Obesity