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A Primary Care Intervention for Weight Management

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00271193
First received: December 29, 2005
Last updated: December 17, 2012
Last verified: March 2010
History of Changes

December 29, 2005
December 17, 2012
September 2005
June 2008   (final data collection date for primary outcome measure)
Weight change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00271193 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: 6, and 12 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 6, and 12 months ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: 6, and 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6, and 12 months ] [ Designated as safety issue: No ]
  • Weight change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Primary Care Intervention for Weight Management
A Primary Care Intervention for Weight Management

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Behavioral: Weight loss counseling
A comparison of weight loss advice provided by primary care physicians to advice plus brief weight loss counseling provided by medical assistants. Participants in both groups receive weight loss materials.
  • No Intervention: 1
    Control group, receives physician advice for weight loss and materials
  • Active Comparator: 2
    Active treatment group, receives physician advice, materials, and brief weight loss counseling
    Intervention: Behavioral: Weight loss counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00271193
no COMIRB number, K24DK065018
Not Provided
University of Colorado, Denver
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Thomas A Wadden, PhD Director, Weight and Eating Disorders Program, University of Pennsylvania
University of Colorado, Denver
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP