New Media Obesity Treatment in Community Health Centers

Study Overview
=================
Brief Summary
-----------------
This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.

Detailed Description
-----------------
This is a patient randomized trial in which patients will be randomized into one of two treatment arms: 1) standard primary care; or 2) primary care plus a 12-month eHealth behavioral intervention (iOTA), which includes interactive self-monitoring and feedback, tailored skills training materials, 18 telephone counseling calls, and primary care provider counseling. The primary outcome is weight change at 12 months. Participants will be 351 adult male and female patients from local community health centers with obesity and a related comorbidity.

Official Title
-----------------
New Media Obesity Treatment in Community Health Centers

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: eHealth weight loss intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 1 visit in the previous 12 months to an adult medicine, internal medicine, or family practice provider at a participating community health center BMI between 30.0-45.0 kg/m2 and weight ≤ 320 pounds Diagnosis of hypertension or diabetes Exclusion Criteria: Current pregnancy Pregnancy in previous 12 months Heart attack/stroke in previous 2 years Active cancer diagnosis Current participation in another weight loss study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth weight loss intervention<br>The 12-month eHealth behavioral intervention includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls from a study coach, and primary care provider counseling. | Behavioral: eHealth weight loss intervention<br>* This trial involves a multi-level, systems-change weight loss intervention. At the provider level, we make it easier for PCPs to deliver weight loss counseling by embedding patient progress data and counseling recommendations in the electronic health record. At the patient level, we provide engaging self-monitoring interfaces, immediate tailored feedback, skills training, and evidence-based lifestyle counseling from trusted care providers.<br>|
| No Intervention: Usual care<br>Participants in the usual care arm will receive the usual primary care services offered by their community health center primary care providers. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Weight will be measured at baseline and 12 months using a SECA 876 scale. | Baseline - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The achievement and maintenance of > 5% weight loss | Weight will be measured at baseline and 12 months using a SECA 876 scale. | Baseline - 12 months | 
| Diet | Dietary assessments will be performed at baseline and 12 months using the ASA24, a self-administered dietary recall measure developed by the National Cancer Institute. | Baseline - 12 months | 
| Cardiometabolic risk markers | Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels | Baseline - 12 months | 
| Global Framingham risk score | The Framingham Risk Score is a validated scoring system used to determine an individual's chances of developing cardiovascular disease. We will calculate this score at baseline and 12 months. | Baseline - 12 months | 
| An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework | RE-AIM was originally developed as a framework for consistent reporting of research results and later used to organize reviews of the existing literature on health promotion and disease management in different settings. The acronym stands for Reach, Effectiveness, Adoption, Implementation, and Maintenance which together determine public health impact. More recently, RE-AIM has been used to translate research into practice and to help plan programs and improve their chances of working in real-world settings. The framework has also been used to understand the relative strengths and weaknesses of different approaches to health promotion and chronic disease self-management-such as in-person counseling, group education classes, telephone counseling, and internet resources. | 12 and 24 months | 
| Physical activity | Physical activity will be measured at baseline and 12 months using the GPAQ (the Global Physical Activity Questionnaire developed by the World Health Organization). | Baseline -12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight loss, primary care, eHealth