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OpenTrials
Completed

NCT Number: NCT00271193

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Edward S. Cooper Internal Medicine Practice, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Weight change

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

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

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 30, 2005
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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