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New Media Obesity Treatment in Community Health Centers

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ClinicalTrials.gov Identifier: NCT01827800
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE April 3, 2013
First Posted Date  ICMJE April 10, 2013
Last Update Posted Date August 13, 2018
Actual Study Start Date  ICMJE June 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
Weight change [ Time Frame: Baseline - 12 months ]
Weight will be measured at baseline and 12 months using a SECA 876 scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
  • 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 ]
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Media Obesity Treatment in Community Health Centers
Official Title  ICMJE New Media Obesity Treatment in Community Health Centers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: eHealth weight loss intervention
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2015)
351
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2013)
350
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01827800
Other Study ID Numbers  ICMJE B0033
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary Bennett, PhD Duke University
PRS Account Duke University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP