A Primary Care Intervention for Weight Management

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. Identifier: NCT00271193
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : October 18, 2017
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Weight loss counseling Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Primary Care Intervention for Weight Management
Study Start Date : September 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Weight change [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 6, and 12 months ]
  2. Lipids [ Time Frame: 6, and 12 months ]
  3. Fasting glucose [ Time Frame: 6, and 12 months ]
  4. Quality of life [ Time Frame: 6, and 12 months ]
  5. Weight change [ Time Frame: 12 months ]
  6. Waist circumference [ Time Frame: 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00271193

United States, Pennsylvania
Edward S. Cooper Internal Medicine Practice
Philadelphia, Pennsylvania, United States, 19104
Presbyterian Medical Group
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
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

Responsible Party: Kaiser Permanente Identifier: NCT00271193     History of Changes
Other Study ID Numbers: K24DK065018 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2005    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017