A Primary Care Intervention for Weight Management
- Conditions
- Healthy
- Interventions
- Behavioral: Weight loss counseling
- Registration Number
- NCT00271193
- Lead Sponsor
- Kaiser Permanente
- Brief Summary
The study will test whether adding brief counseling visits with an ancillary health care provider (a nurse or nursing assistant) will induce additional weight loss, as compared with quarterly physician visits alone. All visits will take place at the site of usual patient care (i.e., the primary care clinic).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Body mass index (BMI) of 27 to 50 kg/m2 Capacity to provide informed consent Ability to find transportation to and from counseling sessions Willingness to be randomized to either program Commitment to attend all sessions and to complete study-related assessments, including blood tests and questionnaires
Type I diabetes Myocardial infarction or stroke within the previous 6 months Clinically significant renal or hepatic disease (as judged by a study physician) History of cancer in the past 5 years Congestive heart failure requiring diuretics Previous weight loss surgery Endocrine conditions that may cause weight gain, including unstable thyroid disease or hypercortisolism Initiation of therapy with or dose change to any of the following medications within 6 weeks of starting the study: insulin; metformin; sulfonylurea; thiazolidinedione; HMG-CoA reductase inhibitor ("statin"); or SSRI for depression Long-term use of any of the following medications: oral or high-dose inhaled steroid; atypical antipsychotic; tricyclic antidepressant; antiepileptic; any prescription or over-the-counter drug for weight loss Systolic blood pressure > 160 or diastolic blood pressure > 100 Hemoglobin A1c ≥ 10 Pregnancy or lactation Clinically significant psychiatric disease, including major depression, eating disorders, or substance abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Weight loss counseling Active treatment group, receives physician advice, materials, and brief weight loss counseling
- Primary Outcome Measures
Name Time Method Weight change 6 months
- Secondary Outcome Measures
Name Time Method Fasting glucose 6, and 12 months Lipids 6, and 12 months Weight change 12 months Waist circumference 6 and 12 months Blood pressure 6, and 12 months Quality of life 6, and 12 months
Trial Locations
- Locations (2)
Presbyterian Medical Group
🇺🇸Philadelphia, Pennsylvania, United States
Edward S. Cooper Internal Medicine Practice
🇺🇸Philadelphia, Pennsylvania, United States