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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telecoaching Plus a Portion Control Device for Weight Care Management

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Telecoaching plus Plate
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telecoaching plus plate<br>Telecoaching plus portion control plate | Behavioral: Telecoaching plus Plate<br>* A wellness coach proactively contacted the participants every two weeks during treatment, using motivational interviewing. In addition, she provided a portion control plate.<br>|
| Active Comparator: Usual Care<br>Usual Care | Behavioral: Usual Care<br>* Subjects were provided with institutional pamphlets on healthy eating and exercise habits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index |  | Baseline, 3 months and 6 months |