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A Primary Care Intervention for Weight Management

NCT ID: NCT00271193

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Control group, receives physician advice for weight loss and materials

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Active treatment group, receives physician advice, materials, and brief weight loss counseling

Group Type ACTIVE_COMPARATOR

Weight loss counseling

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas A Wadden, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Weight and Eating Disorders Program, University of Pennsylvania

Locations

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Edward S. Cooper Internal Medicine Practice

Philadelphia, Pennsylvania, United States

Site Status

Presbyterian Medical Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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K24DK065018

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCT00271193

Identifier Type: OTHER

Identifier Source: secondary_id

NCT00271193

Identifier Type: -

Identifier Source: org_study_id