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A Primary Care Intervention for Weight Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271193
First Posted: December 30, 2005
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kaiser Permanente
December 29, 2005
December 30, 2005
October 18, 2017
September 2005
June 2008   (Final data collection date for primary outcome measure)
Weight change [ Time Frame: 6 months ]
Not Provided
Complete list of historical versions of study NCT00271193 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: 6, and 12 months ]
  • Lipids [ Time Frame: 6, and 12 months ]
  • Fasting glucose [ Time Frame: 6, and 12 months ]
  • Quality of life [ Time Frame: 6, and 12 months ]
  • Weight change [ Time Frame: 12 months ]
  • Waist circumference [ Time Frame: 6 and 12 months ]
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
Intervention Model: Parallel Assignment
Masking: None (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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00271193
K24DK065018 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Kaiser Permanente
Kaiser Permanente
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
Kaiser Permanente
October 2017

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