Telecoaching Plus a Portion Control Device for Weight Management in the Primary Care Setting
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 23, 2015
CompletedFirst Posted
Study publicly available on registry
February 27, 2015
CompletedFebruary 27, 2015
February 1, 2015
1.1 years
February 23, 2015
February 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Body Mass Index
Baseline, 3 months and 6 months
Study Arms (2)
Telecoaching plus plate
ACTIVE COMPARATORTelecoaching plus portion control plate
Usual Care
ACTIVE COMPARATORUsual Care
Interventions
A wellness coach proactively contacted the participants every two weeks during treatment, using motivational interviewing. In addition, she provided a portion control plate.
Subjects were provided with institutional pamphlets on healthy eating and exercise habits
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Huber JM, Shapiro JS, Wieland ML, Croghan IT, Vickers Douglas KS, Schroeder DR, Hathaway JC, Ebbert JO. Telecoaching plus a portion control plate for weight care management: a randomized trial. Trials. 2015 Jul 30;16:323. doi: 10.1186/s13063-015-0880-1.
PMID: 26223309DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon O Ebbert, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
February 23, 2015
First Posted
February 27, 2015
Study Start
May 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
February 27, 2015
Record last verified: 2015-02