New Media Obesity Treatment in Community Health Centers

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01827800
First received: April 3, 2013
Last updated: July 28, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Weight will be measured at baseline and 12 months using a SECA 876 scale.

  • Diet [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels

  • Global Framingham risk score [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Baseline -12 months ] [ Designated as safety issue: No ]
    Physical activity will be measured at baseline and 12 months using the GPAQ (the Global Physical Activity Questionnaire developed by the World Health Organization).


Estimated Enrollment: 350
Study Start Date: June 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 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
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01827800     History of Changes
Other Study ID Numbers: B0033
Study First Received: April 3, 2013
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
weight loss
primary care
eHealth

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

ClinicalTrials.gov processed this record on August 21, 2014