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New Media Obesity Treatment in Community Health Centers

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827800
First Posted: April 10, 2013
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Obesity Behavioral: eHealth weight loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Media Obesity Treatment in Community Health Centers

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Weight change [ Time Frame: Baseline - 12 months ]
    Weight will be measured at baseline and 12 months using a SECA 876 scale.


Secondary Outcome Measures:
  • 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).


Enrollment: 351
Study Start Date: June 2013
Estimated Study Completion Date: July 2018
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Gary Bennett, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01827800     History of Changes
Other Study ID Numbers: B0033
First Submitted: April 3, 2013
First Posted: April 10, 2013
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Duke University:
weight loss
primary care
eHealth

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms