New Media Obesity Treatment in Community Health Centers

August 10, 2018 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
351

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: Baseline - 12 months
Weight will be measured at baseline and 12 months using a SECA 876 scale.
Baseline - 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline - 12 months
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.
Baseline - 12 months
Cardiometabolic risk markers
Time Frame: Baseline - 12 months
Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels
Baseline - 12 months
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.
Baseline - 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.
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).
Baseline -12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gary Bennett, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B0033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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