Expired Study
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Rochester, Minnesota 55905


Purpose:

The purpose of this study was to evaluate the impact of telecoaching conducted by a counselor trained in motivational interviewing paired with a portion control device for obese patients receiving care in a certified patient-centered medical home. We will conduct a randomized, controlled clinical trial evaluating the effectiveness of a telecoaching intervention with a portion control device.


Study summary:

The intervention will be provided during a 3-month period with follow-up through 6 months after randomization. Body mass index (BMI) and waist circumference measurements will be collected at baseline and at 6, 12, 18, and 24 weeks. Participants will also complete measures assessing eating behaviors and physical activity at baseline and at 12 and 24 weeks.


Criteria:

Inclusion Criteria: - 1) men or women ≥ 18 years and ≤ 55 years of age; 2) a BMI of ≥ 30 and ≤ 44.9 kg/m2; 3) motivated to lose weight; 4) able to participate fully in all aspects of the study; and 5) have been provided with, understand, and have signed the informed consent. Exclusion Criteria: - 1) unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia; 2) a history of a gastric bypass procedure or planned gastric bypass; 3) baseline systolic blood pressure > 180 or diastolic > 100; 4) another member of their household already participating in this study; 5) current treatment with another investigational drug for obesity (within 30 days of study entry); 6) are pregnant or lactating; 7) history of anorexia or bulimia; 8) current binge eating disorder as assessed by the Patient Health Questionnaire eating disorder module (PHQ-ED)36; 9) schizophrenia or bipolar disorder or have a PHQ-2 ≥ 337; 10) have been diagnosed with cancer within the past 5 years; or 11) are currently participating in a program specifically to lose weight or are on a weight loss medication (last 30 days).


NCT ID:

NCT02373878


Primary Contact:

Principal Investigator
Jon O Ebbert, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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