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CompletedNCT02373878Updated Feb 27, 2015

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

An interventional study of Telecoaching plus Plate and Usual Care in Obesity, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-27.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Obesity

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03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 90 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

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Lead sponsor

Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Telecoaching plus plate

    Telecoaching plus portion control plate

    Behavioral: Telecoaching plus Plate

  • Active comparator
    Usual Care

    Usual Care

    Behavioral: Usual Care

Interventions

  • BehavioralTelecoaching 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.

  • BehavioralUsual Care

    Subjects were provided with institutional pamphlets on healthy eating and exercise habits

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What researchers measure

Primary outcomes

  1. Change in Body Mass Index

    Time frame: Baseline, 3 months and 6 months

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Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
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References and documents

Publications

  • 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. PubMed 26223309 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2015
First posted
Feb 27, 2015
Start
May 2011
Primary completionActual
Jun 2012
CompletionActual
Jun 2012
Last update
Feb 27, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02373878
Lead sponsor
Mayo Clinic
Responsible party
Jon Ebbert (Professor of Medicine, Mayo Clinic) — Principal investigator
First posted
Feb 27, 2015
Start date
May 2011
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Feb 27, 2015

Study contacts

Jon O Ebbert, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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