A Primary Care Intervention for Weight Management
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/20/2017 |
| Start Date: | September 2005 |
| End Date: | June 2008 |
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).
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).
Inclusion Criteria:
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
Exclusion Criteria:
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
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