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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
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Provider Voice
Behavioral: Generic Voice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An RCT of Provider-to-Patient IVR Calls to Improve Weight Management in CHCs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

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

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

Enrollment: 1228
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

 

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients who have screened positive for overweight or obesity

Exclusion Criteria:

  • Patients who have not screened positive for overweight or obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131143

Locations
United States, Indiana
Indiana University Center on Aging Research-Regenstrief Institute
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Daniel O Clark, PhD Indiana School of Medicine
  More Information

No publications provided

Responsible Party: Kimberly Hemmerlein, Researcher Coodinator, Indiana University
ClinicalTrials.gov Identifier: NCT01131143     History of Changes
Other Study ID Numbers: 0902-70
Study First Received: September 14, 2009
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Urban community centers
Obesity
Obesity counseling
Urban Community Centers
Low-cost intervention

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

ClinicalTrials.gov processed this record on May 23, 2013