Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The primary objective of the study is to evaluate the effectiveness of tailored lifestyle
      intervention in primary care by comparing changes in the primary measure of weight and body
      mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and
      fruit/vegetable servings within the two arms (intervention and control) of the study. It is
      hypothesized that the intervention cohort will demonstrate greater reductions in body weight,
      body neglect, and fat calories consumed and greater increases in physical activity and
      fruits/vegetable servings after two years compared to the control cohort. The study also aims
      to evaluate and compare the cost of intervention for purpose per each unit of measure lost
      between the two arms of the study as a secondary objective. The cost of intervention will be
      evaluated as it relates to study replication.
    

Detailed description: 
      The study will translate and evaluate previously successful weight loss and physical activity
      studies into a primary care setting in terms of efficacy and cost effectiveness. Patients are
      recruited by their primary care physicians office and screened for participation and
      contraindications by phone. A screening visit with a run-in period of food and exercise log
      adherence is performed. All participants have meetings with a Lifestyle Counselor to set
      nutritional and lifestyle goals and an introduction to weight loss techniques at baseline, 6
      months, and 12 months. A structured eating plan will be given at the baseline visit.
      Participants at the baseline visit are randomized to either the intervention and control
      groups. During the first year, intervention participants will receive monthly motivational
      phone calls from their lifestyle counselor to assess their progress and help navigate the
      lifestyle changes. Food and exercise logs are reviewed frequently and written feedback give
      to each interventional participant. Intervention participants also receive weekly mailings
      focusing on weight loss, physical activity and healthy eating, and four tailored mailings
      based upon information gained through contact with the lifestyle counselor. Intervention
      participants will also receive 2 informative DVDs during the first year. Control participants
      receive 2 NIDDK informational handouts on weight loss. For the second year of the study
      focuses on maintenance. Intervention participants receive reduced mailings of 2 per month for
      6 months and then once a month until the end of one year. Intervention participants receive
      one additional motivational phone call at 13 months if they have not reached their weight
      loss goal and also receive 2 more informative DVDs. The control participants will receive 3
      informational NIDDK mailings. The two arms of the study will be compared using the critical
      outcome measures (weight loss, PA, fat calories & vegetable/fruit servings consumed) and
      secondary outcome measures (waist and hip circumference,BP,Heart rate) for weight loss
      efficacy. We will also evaluate the cost-effectiveness for dissemination as a PCP weight loss
      program in addition to the overall cost-effectiveness for the participant in terms of money
      spent and adverse events related to the lifestyle change.
    

Intervention name(s): Intervention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Lifestyle Counselor meetings at baseline, 6 months, and 12 months
Structured eating plan
Tailored nutritional and exercise tips. Weekly: months 1-12, biweekly: months 13-18, and monthly: months 19-24.
Monthly Motivational phone calls with Lifestyle Counselor for the first year
4 informational DVDs over the two year period
Feedback on submitted food and exercise journals; Lifestyle Counselor meetings at baseline, 6 months, and 12 months
Structured eating plan
5 informational NIDDK mailings over the two year period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lifestyle change; obesity treatment; physical activity; primary care; quality of life