Study to Promote Physical Activity Among Overweight Persons
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Recent research suggests that overweight persons who are physically active may be
      significantly less likely to develop health complications and less likely to die early when
      compared even with lean persons who are not physically active. Previous treatment programs
      for people who have struggled with their weight have focused almost entirely on weight loss
      as the main goal of treatment. Our research program has a different focus. We hope to improve
      health and healthy self esteem independent of body weight by focusing instead on increasing
      physical activity as the main goal of treatment. This is a small study designed to see if
      this approach would be appealing to persons who are struggling with their weight who are
      currently sedentary. It is designed for people who are otherwise fairly healthy for whom
      exercise is reasonably safe. Participants are randomly (by chance) assigned to participate in
      the experimental treatment program or instead to meet with their regular primary care doctor.
      Those who are assigned to meet with their regular doctor can access traditional weight loss
      resources such as Weight Watchers, Jenny Craig, Fitness centers etc... After the experiment
      is complete, these participants will have the opportunity to participate in the experimental
      treatment program.
    

Detailed description: 
      OBJECTIVE: Epidemiologic evidence suggests that overweight persons who engage in modest
      amounts of physical activity - even that insufficient to produce or maintain weight loss -
      are at significantly reduced risk for health complications including all-cause mortality.
      Interventions for overweight persons targeting increased physical activity rather than weight
      loss as the main outcome of treatment have not been well studied and could represent simpler,
      more sustainable, and more cost-effective approaches in addressing the obesity epidemic.

      METHOD: Pilot randomized controlled trial. Sedentary patients with BMI 25-45, and no major
      contraindications for unsupervised physical activity recruited. Participants randomized to
      receive either brief consultation consisting of 3 in-person meetings, a workbook, and limited
      telephone contact or usual care with their medical provider including access to community
      weight-loss groups/resources. Intervention therapists novice pre-professional students. The
      intervention is manualized and coded for treatment integrity. The main outcome measures are
      Cohen's d effect sizes and 95% confidence intervals for the change in moderate-equivalent
      intensity physical activity/week at 3 months relative to baseline assessed by a blinded
      assessor using the Stanford 7-Day Physical Activity Recall. Secondary outcomes include effect
      sizes and confidence intervals for changes in cardiorespiratory fitness and depression using
      the modified Canadian Aerobic Fitness test and Beck Depression Inventory. Analyses to be
      performed by intention to treat. Missing data to be imputed by baseline observation carried
      forward.
    

Intervention name(s): Brief Consultation with Health Counselor, workbook; Usual Care wait list
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: physical activity; sedentary; behavioral medicine; motivational interviewing