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

Mayo Clinic

Status

Completed

Conditions

Obesity

Treatments

Behavioral: Telecoaching plus Plate

Behavioral: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02373878

11001395

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)