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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kimberly Hemmerlein, Indiana University

ClinicalTrials.gov Identifier:

NCT01131143

First received: September 14, 2009

Last updated: March 29, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2009

Last Updated Date

March 29, 2013

Start Date ^ICMJE

June 2009

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Weight loss refer by provider [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01131143 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

attendance at program, weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Obesity

Intervention ^ICMJE

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.
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.

Study Arm (s)

Experimental: Treatment Group 1
Patients will receive a pre-visit, post-referral and post-contact phone call using providers voice

Intervention: Behavioral: Provider Voice
Experimental: Treatment Group 2
Patients will receive a previsit, post-referral and post-contact call using a generic voice

Intervention: Behavioral: Generic Voice
No Intervention: Treatment Group 3
Patients will be provided usual care with no additional phone calls.

Publications *

Not Provided

* 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

Enrollment ^ICMJE

1228

Completion Date

January 2012

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients who have screened positive for overweight or obesity

Exclusion Criteria:

Patients who have not screened positive for overweight or obesity

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01131143

Other Study ID Numbers ^ICMJE

0902-70

Has Data Monitoring Committee

Responsible Party

Kimberly Hemmerlein, Indiana University

Study Sponsor ^ICMJE

Indiana University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Daniel O Clark, PhD

Indiana School of Medicine

Information Provided By

Indiana University

Verification Date

March 2013

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

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