Diabetes PreventionDiaBEAT-itNCT02162901
The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs
A study testing Choice-Class with IVR Calls, Random-Class with IVR calls and Random-Class only in people with Diabetes Prevention, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a health care setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention
- What is being tested?
- Choice-Class with IVR Calls, Random-Class with IVR calls and Random-Class only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2014to 28 Apr 2017
- 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
- age = or > 18 years
- BMI = or > 25
Who cannot join
- Patient's medical record contains ICD-9 codes for a diagnosis of any type of diabetes, congestive heart failure or coronary artery disease
- Pregnant or becomes pregnant during trial
- Contraindication to physical activity or weight loss
- No access to phone
- Does not speak or read English
- Patient has indicated "Do Not Contact" in Carilion patient record
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Tech Translational Obesity Research Center
Roanoke, Virginia, 24016
About this study
The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a health care setting. The overall aim is consistent with the NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. While evidence of lifestyle interventions that increase physical activity and improve eating habits to achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues to mount, the translation of these interventions into effective programs to health care settings with modest resources remains a challenge. The proposed research project will conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in achieving objectively verified weight loss relative to a standard care control at comparatively lower costs. Adult patients (18 years of age and older) at risk for developing diabetes will be randomized to either the Choice group or the Randomization group. Those patients randomized to the Choice group (n=240) will have the opportunity to choose one of two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated interactive voice response (IVR) systems targeting personal action planning to support lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC). SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures include weight loss, cost, and reach of each program. Secondary outcome measures include physical activity behavior; eating behavior; and process evaluation. It is hypothesized that both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of weight loss at 6, 12, and 18 months following program initiation than SC but will not differ from one another. The investigators also hypothesize that the DVD/IVR will have broader reach and may be more cost-effective than SG/IVR or SC.
- Conditions
- Diabetes Prevention
- Being tested
- Choice-Class with IVR Calls, Random-Class with IVR calls, Random-Class only, Choice-DVD with IVR calls, Random-DVD with IVR calls
- Keywords
- Diabetes prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice-Class with IVR CallsBehavioural
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone call over a period of 12 months.
Random-Class with IVR callsBehavioural
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
Random-Class onlyBehavioural
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through a printed workbook.
Choice-DVD with IVR callsBehavioural
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
Random-DVD with IVR callsBehavioural
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Choice-Class with IVR Calls | Experimental | Participants enrolled in this arm of the study will have chosen to attend one 2-hour class to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months. Receives: Behavioral: Choice-Class with IVR Calls |
| Choice-DVD with IVR calls | Experimental | Participants enrolled in this arm of the study will have chosen to watch a DVD at home to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months Receives: Behavioral: Choice-DVD with IVR calls |
| Random-Class with IVR calls | Experimental | Participants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will attend one 2-hour class to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months Receives: Behavioral: Random-Class with IVR calls |
| Random-DVD with IVR calls | Experimental | Participants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will be given a DVD to watch at home to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months Receives: Behavioral: Random-DVD with IVR calls |
| Random-Class only | Active comparator | Participants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will attend one 2-hour class to be introduced to the intervention and will receive a workbook to use at home. Receives: Behavioral: Random-Class only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight as measured by clinical scale at baseline, and 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study start13 Mar 2014
- Primary completion5 Jan 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes PreventionStudies of the same condition, open and under way.
- 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
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Carilion Clinic, University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Fabio A Almeida, PhD, MSW, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162901
- Sponsor's protocol ID
- 1R18DK091811-01A1
- Other IDs
- 1R18DK091811-01A1
- Acronym
- DiaBEAT-it
- Status last verified
- Apr 2021
- First submitted
- 11 Jun 2014
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Almeida FA, You W, Brito FA, Alves TF, Goessl C, Wall SS, Seidel RW, Davy BM, Greenawald MH, Hill JL, Estabrooks PA. A randomized controlled trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it study. Front Public Health. 2023 Feb 24;11:1000162. doi: 10.3389/fpubh.2023.1000162. eCollection 2023.
PubMed 36908422
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs
- ClinicalTrials.gov ID
- NCT02162901
- Acronym / sponsor ID
- DiaBEAT-it / 1R18DK091811-01A1
- Conditions
- Diabetes Prevention
- Keywords
- Diabetes prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Carilion Clinic, University of Nebraska
- Study start
- 13 Mar 2014 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 13 Jun 2014 (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.
The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a health care setting. The overall aim is consistent with the NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. While evidence of lifestyle interventions that increase physical activity and improve eating habits to achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues to mount, the translation of these interventions into effective programs to health care settings with modest resources remains a challenge. The proposed research project will conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in achieving objectively verified weight loss relative to a standard care control at comparatively lower costs. Adult patients (18 years of age and older) at risk for developing diabetes will be randomized to either the Choice group or the Randomization group. Those patients randomized to the Choice group (n=240) will have the opportunity to choose one of two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated interactive voice response (IVR) systems targeting personal action planning to support lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC). SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures include weight loss, cost, and reach of each program. Secondary outcome measures include physical activity behavior; eating behavior; and process evaluation. It is hypothesized that both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of weight loss at 6, 12, and 18 months following program initiation than SC but will not differ from one another. The investigators also hypothesize that the DVD/IVR will have broader reach and may be more cost-effective than SG/IVR or SC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Choice-Class with IVR Calls | Experimental | Behavioral: Choice-Class with IVR CallsParticipants enrolled in this arm of the study will have chosen to attend one 2-hour class to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months. |
| Choice-DVD with IVR calls | Experimental | Behavioral: Choice-DVD with IVR callsParticipants enrolled in this arm of the study will have chosen to watch a DVD at home to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months |
| Random-Class with IVR calls | Experimental | Behavioral: Random-Class with IVR callsParticipants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will attend one 2-hour class to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months |
| Random-DVD with IVR calls | Experimental | Behavioral: Random-DVD with IVR callsParticipants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will be given a DVD to watch at home to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months |
| Random-Class only | Active comparator | Behavioral: Random-Class onlyParticipants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will attend one 2-hour class to be introduced to the intervention and will receive a workbook to use at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age = or > 18 years
- BMI = or > 25
Key exclusion criteria (6 listed)
- Patient's medical record contains ICD-9 codes for a diagnosis of any type of diabetes, congestive heart failure or coronary artery disease
- Pregnant or becomes pregnant during trial
- Contraindication to physical activity or weight loss
- No access to phone
- Does not speak or read English
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 |
|---|---|---|
| Choice-Class with IVR CallsThe intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone call over a period of 12 months. | Behavioural | Choice-Class with IVR Calls |
| Random-Class with IVR callsThe intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months. | Behavioural | Random-Class with IVR calls |
| Random-Class onlyThe intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through a printed workbook. | Behavioural | Random-Class only |
| Choice-DVD with IVR callsThe intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months. | Behavioural | Choice-DVD with IVR calls |
| Random-DVD with IVR callsThe intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months. | Behavioural | Random-DVD with IVR calls |
Primary outcome
Body weight
Time frame: 12 months
Weight as measured by clinical scale at baseline, and 12 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 6 Apr 2021.
- Derived from this study: PubMed 36908422Almeida FA, You W, Brito FA, Alves TF, Goessl C, Wall SS, Seidel RW, Davy BM, Greenawald MH, Hill JL, Estabrooks PA. A randomized controlled trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it study. Front Public Health. 2023 Feb 24;11:1000162. doi: 10.3389/fpubh.2023.1000162. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Fabio A Almeida, PhD, MSW principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choice-Class with IVR Calls, Random-Class with IVR calls and Random-Class only in people with Diabetes Prevention, run by Virginia Polytechnic Institute and State 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 2 inclusion and 6 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 6 Apr 2021. 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?
Body weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02162901, which also lists 1 linked publication.
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 6 Apr 2021.