Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose

Completed · Not applicable

Conditions studied: Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT01542671

Run by

Memorial Hospital of Rhode Island

People needed

200

Starts

2009-09-01

Expected to finish

2015-07-01

Last updated by the study team

2016-04-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male/female ≥18 and <80 years old
• Available for this research project for the entire 24-month study period
• Able to read and speak English
• Can provide informed consent

You may not qualify if…

• Diagnosed or hospitalization for active CVD disease in the past 6 months including: CHD or history of coronary revascularization procedure (e.g. angioplasty, bypass graft surgery), Stroke, Peripheral Vascular Disease, Heart Failure, Deep Vein Thrombosis (DVT)
• Unstable psychiatric condition
• History of a significant orthopedic limitation or other conditions that make exercise dangerous or extremely difficult
• Limited physical activity by a physician to less than a brisk walk
• Another family member in the study
• Limited prescribed diet (e.g. gluten free diet)
• Present treatment for an eating disorder
• Underwent treatment for cancer in the past 5 years
• Dialysis
• Poorly controlled diabetes (HgbA1c > 10) or hospitalized in past 6 months for poorly controlled diabetes
• Chronic steroid therapy
• Participant requesting surgical treatment of obesity or weighing over 400 lbs.
• Major surgery in the past month
• Participating in another clinical trial with regards to obesity or physical activity

Where it is running

• Memorial Hospital of Rhode Island — Pawtucket, Rhode Island, United States

Full record on ClinicalTrials.gov

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