Ferrante 2016.

Trial name or title	Virtual weight loss programme in maintaining weight in African American breast cancer survivors
Methods	Randomised controlled trial
Participants	Breast cancer survivors with previous invasive carcinoma at stage IA to IIIC, randomised to control or intervention group
Interventions	Experimental: group I (SparkPeople programme). Patients receive one 30‐minute session with the research assistant for training on how to use the SparkPeople website, and may request additional training if needed. Patients are instructed to self‐monitor their diet at least weekly using SparkPeople and physical activity levels daily using the Fitbit monitoring device, which integrates with the SparkPeople programme. Patients receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Patients then enter the maintenance phase for an additional 3 months without reminders Active comparator: group II (wait‐list). Patients receive the weight loss handout and a Fitbit health monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I
Outcomes	Time frame: up to 12 months Primary outcome measures: changes in weight, recruitment, retention rate Secondary outcome measures: changes in caloric intake, in cardio‐metabolic risk factors, in cardiopulmonary fitness, in physical activity, in quality of life for social‐cognitive theory variables Patient feedback on programme, as measured by semi‐structured interview
Starting date	May 2015
Contact information	Principal Investigator: Jeanne Ferrante, 732‐743‐3222; Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States 08903
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