Trial of Provider-to-Patient Interactive Voice Response (IVR) Calls to Improve Weight Management in Community Health Centers (CHCs) (IVR)

March 29, 2013 updated by: Kimberly Hemmerlein, Indiana University

An RCT of Provider-to-Patient IVR Calls to Improve Weight Management in CHCs

This study will test the effect of provider to patient interactive voice response (IVR) calls in local Community Health Centers within a weight management program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will randomize providers to three groups. Patients whose provider has been randomized to usual care will not receive IVR calls but do have available a guideline-level weight management service in TCL. Groups one and two will receive pre-visit and post-referral calls. The pre-visit call will invite patients who want to discuss weight at their upcoming visit with their provider to remember to do so. The post-referral call will remind patients that they have received a referral and encourage them to schedule a visit with the community based weight intervention program. Patients whose provider has been randomized to group 1 will receive IVR calls using their scheduled and referring provider's voice. Group 2 will receive IVR calls using a standard IVR voice.

Study Type

Interventional

Enrollment (Actual)

1228

Phase

  • 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
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Center on Aging Research-Regenstrief Institute

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients who have screened positive for overweight or obesity

Exclusion Criteria:

  • Patients who have not screened positive for overweight or obesity

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1
Patients will receive a pre-visit, post-referral and post-contact phone call using providers voice
Behavioral: Provider Voice
A phone call with the pre-recorded doctor's voice will be made to their patients who have been pre-screened for obesity before the patient's appointments prompting the patients to ask about physical activity, nutrition, and weight loss.
Experimental: Treatment Group 2
Patients will receive a previsit, post-referral and post-contact call using a generic voice
Behavioral: Generic Voice
A phone call with a pre-recorded neutral voice will be made to the doctor's patients who have been prescreened for obesity before their patient's appointments. The call will prompt them to ask ask their doctor about physical activity, nutrition, and weight loss.
No Intervention: Treatment Group 3
Patients will be provided usual care with no additional phone calls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss refer by provider
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
attendance at program, weight loss
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Indiana University

Investigators

  • Principal Investigator: Daniel O Clark, PhD, Indiana School of Medicine

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

June 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

April 2, 2013

Last Update Submitted That Met QC Criteria

March 29, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0902-70

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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