A Primary Care Intervention for Weight Management

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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 Intervention Phase
Healthy
Behavioral: Weight loss counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Primary Care Intervention for Weight Management

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Weight change [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: September 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271193

Locations
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
University of Colorado, Denver
Investigators
Principal Investigator: Thomas A Wadden, PhD Director, Weight and Eating Disorders Program, University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00271193     History of Changes
Other Study ID Numbers: no COMIRB number, K24DK065018
Study First Received: December 29, 2005
Last Updated: December 17, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 21, 2014