A Primary Care Intervention for Weight Management

NCT00271193 | Completed Phase 3

• 2 other identifiers: NCT00271193K24DK065018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Weight change

  6 months

Secondary Outcomes (6)

• Blood pressure

  6, and 12 months

• Lipids

  6, and 12 months

• Fasting glucose

  6, and 12 months

• Quality of life

  6, and 12 months

• Weight change

  12 months

Study Arms (2)

1

NO INTERVENTION

Control group, receives physician advice for weight loss and materials

2

ACTIVE COMPARATOR

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

Behavioral: Weight loss counseling

Interventions

Weight loss counseling 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Edward S. Cooper Internal Medicine Practice

Philadelphia, Pennsylvania, 19104, United States

Location

Presbyterian Medical Group

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Thomas A Wadden, PhD

  Director, Weight and Eating Disorders Program, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

US (2)