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Telecoaching Plus a Portion Control Device for Weight Management in the Primary Care Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373878
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic

Brief Summary:
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. The investigators will conduct a randomized, controlled clinical trial evaluating the effectiveness of a telecoaching intervention with a portion control device.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Telecoaching plus Plate Behavioral: Usual Care Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telecoaching Plus a Portion Control Device for Weight Care Management
Study Start Date : May 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Active Comparator: Telecoaching plus plate
Telecoaching plus portion control plate
Behavioral: Telecoaching plus Plate
A wellness coach proactively contacted the participants every two weeks during treatment, using motivational interviewing. In addition, she provided a portion control plate.

Active Comparator: Usual Care
Usual Care
Behavioral: Usual Care
Subjects were provided with institutional pamphlets on healthy eating and exercise habits




Primary Outcome Measures :
  1. Change in Body Mass Index [ Time Frame: Baseline, 3 months and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women ≥ 18 years and ≤ 55 years of age
  • A BMI of ≥ 30 and ≤ 44.9 kg/m2
  • Motivated to lose weight
  • Able to participate fully in all aspects of the study;
  • Have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

  • Unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia
  • A history of a gastric bypass procedure or planned gastric bypass
  • Baseline systolic blood pressure > 180 or diastolic > 100
  • Another member of their household already participating in this study
  • Current treatment with another investigational drug for obesity (within 30 days of study entry)
  • Are pregnant or lactating
  • History of anorexia or bulimia
  • Current binge eating disorder as assessed by the Patient Health Questionnaire eating disorder module (PHQ-ED)
  • Schizophrenia or bipolar disorder or have a PHQ-2 ≥ 337
  • Have been diagnosed with cancer within the past 5 years
  • Are currently participating in a program specifically to lose weight or are on a weight loss medication (last 30 days)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373878


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Jon O Ebbert, MD Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jon Ebbert, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02373878    
Other Study ID Numbers: 11001395
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015