MedDataX Logo

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

NCT ID: NCT02373878

Last Updated: 2015-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telecoaching plus plate

Telecoaching plus portion control plate

Group Type ACTIVE_COMPARATOR

Telecoaching plus Plate

Intervention Type BEHAVIORAL

A wellness coach proactively contacted the participants every two weeks during treatment, using motivational interviewing. In addition, she provided a portion control plate.

Usual Care

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jon Ebbert

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jon O Ebbert, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26223309 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11001395

Identifier Type: -

Identifier Source: org_study_id