New Media Obesity Treatment in Community Health Centers
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|ClinicalTrials.gov Identifier: NCT01827800|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2013
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: eHealth weight loss intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||351 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||New Media Obesity Treatment in Community Health Centers|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||July 2018|
Experimental: eHealth weight loss intervention
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
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.
No Intervention: Usual care
Participants in the usual care arm will receive the usual primary care services offered by their community health center primary care providers.
- Weight change [ Time Frame: Baseline - 12 months ]Weight will be measured at baseline and 12 months using a SECA 876 scale.
- The achievement and maintenance of > 5% weight loss [ Time Frame: Baseline - 12 months ]Weight will be measured at baseline and 12 months using a SECA 876 scale.
- Diet [ Time Frame: Baseline - 12 months ]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.
- Cardiometabolic risk markers [ Time Frame: Baseline - 12 months ]Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels
- Global Framingham risk score [ Time Frame: Baseline - 12 months ]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.
- An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework [ Time Frame: 12 and 24 months ]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.
- Physical activity [ Time Frame: Baseline -12 months ]Physical activity will be measured at baseline and 12 months using the GPAQ (the Global Physical Activity Questionnaire developed by the World Health Organization).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827800
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Gary Bennett, PhD||Duke University|