Obesity
Conditions
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.
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
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Body Mass Index | Baseline, 3 months and 6 months |
Countries
United States
Outcome results
None listed