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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Telecoaching plus Plate; Behavioral: Usual Care

• Registration Number: NCT02373878
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-02
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-26
• Last Update Submitted: 2015-02-26
• Study First Posted: 2015-02-27
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telecoaching plus plate	Telecoaching plus Plate	Telecoaching plus portion control plate
Usual Care	Usual Care	Usual Care

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index	Baseline, 3 months and 6 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States