Lifestyle, Exercise and Nutrition Study 1
Condition: Breast Cancer; Weight Loss
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aims of this study are to determine the efficacy and cost-effectiveness of a
      weight loss program compared with usual care (control) treatment on 6-month changes in body
      weight, body fat, and serum hormones in breast cancer survivors.
    

Detailed description: 
      Proposed is a three-arm randomized controlled trial of 6-months of weight loss counseling
      (i.e., dietary-induced caloric restriction and physical activity) on clinically meaningful
      endpoints in 100 breast cancer survivors . The three arms will be: 1. In-person counseling,
      2. Telephone-based counseling, 3. Usual care. Women will be randomized into one of 3 study
      arms using a random permuted block design. Research staff collecting body composition data,
      as well as reviewing forms and entering data, will be blinded to the participant's study
      group.
    

Intervention name(s): Weight Loss Counseling- Phone; Weight Loss Counseling- In-Person
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification.
During the 6-month intervention, participants will receive weekly (month 1), then bi-weekly (months 2 and 3), then monthly (months 4, 5, and 6) individualized counseling sessions. An advantage of tapering the frequency of visits from weekly to every other week and then monthly works as a process tool to help transfer the work or responsibility onto the participant for life long change and maintenance of behavior change.; The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification.
During the 6-month intervention, participants will receive weekly (month 1), then bi-weekly (months 2 and 3), then monthly (months 4, 5, and 6) individualized counseling sessions. An advantage of tapering the frequency of visits from weekly to every other week and then monthly works as a process tool to help transfer the work or responsibility onto the participant for life long change and maintenance of behavior change.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast Cancer; Survivorship; Weight Loss