ObesityIVRNCT01131143
Trial of Provider-to-Patient Interactive Voice Response (IVR) Calls to Improve Weight Management in Community Health Centers (CHCs)
A study testing Provider Voice and Generic Voice in people with Obesity, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Provider Voice and Generic Voice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,228 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients who have screened positive for overweight or obesity
Who cannot join
- Patients who have not screened positive for overweight or obesity
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Center on Aging Research-Regenstrief Institute
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Provider Voice, Generic Voice
- Keywords
- Urban community centers, Obesity, Obesity counseling, Low-cost intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider VoiceBehavioural
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.
Generic VoiceBehavioural
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 group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Patients will receive a pre-visit, post-referral and post-contact phone call using providers voice Receives: Behavioral: Provider Voice |
| Treatment Group 2 | Experimental | Patients will receive a previsit, post-referral and post-contact call using a generic voice Receives: Behavioral: Generic Voice |
| Treatment Group 3 | No intervention | Patients will be provided usual care with no additional phone calls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss refer by provider
Measured: 6 months
Secondary outcomes (1)
attendance at program, weight loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Hemmerlein, Indiana University
- Investigators
- Daniel O Clark, PhD, Principal investigator, Indiana School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131143
- Sponsor's protocol ID
- 0902-70
- Acronym
- IVR
- Status last verified
- Mar 2013
- First submitted
- 14 Sep 2009
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT of Provider-to-Patient IVR Calls to Improve Weight Management in CHCs
- ClinicalTrials.gov ID
- NCT01131143
- Acronym / sponsor ID
- IVR / 0902-70
- Conditions
- Obesity
- Keywords
- Urban community centers, Obesity, Obesity counseling, Low-cost intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,228 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Behavioral: Provider VoicePatients will receive a pre-visit, post-referral and post-contact phone call using providers voice |
| Treatment Group 2 | Experimental | Behavioral: Generic VoicePatients will receive a previsit, post-referral and post-contact call using a generic voice |
| Treatment Group 3 | No intervention | –Patients will be provided usual care with no additional phone calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who have screened positive for overweight or obesity
Key exclusion criteria (1 listed)
- Patients who have not screened positive for overweight or obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provider VoiceA 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. | Behavioural | Treatment Group 1 |
| Generic VoiceA 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. | Behavioural | Treatment Group 2 |
Primary outcome
Weight loss refer by provider
Time frame: 6 months
1 secondary outcome
attendance at program, weight loss
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel O Clark, PhD principal investigator
Indiana School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Voice and Generic Voice in people with Obesity, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss refer by provider (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.