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COMPAR-EU RCTs Web

Randomized trial comparing telephone versus in-person weight loss counseling on body composition and circulating biomarkers in women treated for breast cancer: The lifestyle, exercise, and nutrition (LEAN) study

Author: Harrigan, M. Country/countries: United States Number of patients participating in the study: 100 This study was focused on patients living with Obesity
Intervention analysed in the study: Usual Care Plus Intervention components: UCP
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Setting of implementation: Home-care, Outpatient care (hospital) Professionals delivering the intervention: N/A Targeted self-management behaviours: Eating behaviours, Physical activity /exercise
Intervention analysed in the study: Monitoring and emotional-based behavioural techniques Intervention components: E+MT+EB
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: Dietician/nutritionist Targeted self-management behaviours: Eating behaviours, Handling /managing emotions, Physical activity /exercise, Self-monitoring
Intervention analysed in the study: Monitoring and emotional-based behavioural techniques delivered remotely Intervention components: E+MT+EB+R
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: Dietician/nutritionist Targeted self-management behaviours: Eating behaviours, Handling /managing emotions, Physical activity /exercise, Self-monitoring

Outcomes measured in the study

Outcome Measure Tool
Healthy nutrition habits/personalized nutrition Consumption of fat N/A
Healthy nutrition habits/personalized nutrition Fiber consumption N/A
Healthy nutrition habits/personalized nutrition Fruit and vegetable consumption N/A
Physical Activity Physical Activity Intensity N/A
Physical Activity Total steps N/A
Weight management Weight (Kgs/lbs) N/A
Weight management Waist size N/A
Weight management Hip size N/A
Weight management Body fat N/A

Patient characteristics

Age: 59.0 years (+/- a standard deviation of 7.5) Gender: 100 females Time since diagnosis of Obesity: N/A Severity of the disease: 33.1 (+/- a standard deviation of 6.6) Multi-morbidity: N/A
  • Number of co-morbidities: 1.0

Level of health literacy: N/A
  • Tool: N/A

Socio-economic characteristics: N/A

Risk of Bias of this study

Outcome Random sequence generation Allocation concealment Blinding performance Blinding detection objective outcomes assessment Attrition incomplete outcome Incorrect statistical methods Recruitment bias Selective outcome reporting
Healthy nutrition habits/personalized nutrition - Consumption of fat
Healthy nutrition habits/personalized nutrition - Fiber consumption
Healthy nutrition habits/personalized nutrition - Fruit and vegetable consumption
Physical Activity - Physical Activity Intensity
Physical Activity - Total steps
Weight management - Weight (Kgs/lbs)
Weight management - Waist size
Weight management - Hip size
Weight management - Body fat