Prediabetic StateNCT03025607
A Mobile Phone-based Program for Adults With Prediabetes
A study testing JOOL Health Mobile Phone Application in people with Prediabetic State and Diabetes Mellitus, run by University of Michigan at 1 site in United States.
Trial summary
Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical activity, yet its prevalence continues to rise. This trend may be due in part to low rates of participation in evidence-based lifestyle change programs such as the Diabetes Prevention Program (DPP). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Prediabetic State, Diabetes Mellitus
- What is being tested?
- JOOL Health Mobile Phone Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2017to 1 Mar 2018
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invited to participate in a DPP by the participant's health plan, but have not engaged in a program at least 6 months after receiving the first letter of invitation
- Wireless internet access
- Personal smartphone access
Who cannot join
- Individuals currently participating in another lifestyle or behavior change program or research study
- Inability to read, write, or speak English
- Inability to provide informed consent
- Women who are pregnant or intend to become pregnant during the intervention period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed Methods Pilot Randomized Controlled Trial of a Mobile Phone-based Health Program Among Adults With Prediabetes
Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical activity, yet its prevalence continues to rise. This trend may be due in part to low rates of participation in evidence-based lifestyle change programs such as the Diabetes Prevention Program (DPP). New strategies are needed to promote healthy behaviors among individuals at risk for T2DM, and mobile health technologies may be an effective and scalable approach to achieve this. One promising tool is JOOL Health, a mobile phone-based application that leverages principles from Self-Determination Theory to help individuals understand how certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue their core values and purpose in life. Through personalized messaging and feedback, JOOL Health aims to increase autonomous motivation, a form of motivation closely associated with the initiation and maintenance of healthy behaviors.
In this mixed methods pilot randomized controlled trial, the investigators will test whether the JOOL Health mobile phone-based application -- used alone and in conjunction with other mobile health technologies to track weight and physical activity -- can increase autonomous motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who previously declined participation in a Diabetes Prevention Program (DPP).
Read the detailed description
This 12-week pilot randomized controlled trial aims to recruit 156 individuals with prediabetes who declined participation in a formal DPP despite invitation to participate at no out-of-pocket cost by their health plan. Participants will be randomized to 1 of 3 study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to diabetes, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (control group); (2) a group that receives the JOOL Health mobile phone application; and (3) a group that receives the JOOL Health mobile phone application and other mHealth tools (e.g. Fitbit activity tracker and wireless-enabled scale) whose results can be uploaded into JOOL.
The investigators will use a mixed methods approach with a sequential explanatory design, which is to say that quantitative data and qualitative data will be collected in 2 consecutive phases within the study. Specifically, in the first phase, investigators will collect and analyze qualitative data (e.g. focus groups) from a purposive sample of participants with differing levels of engagement and success. The rationale for this approach is that the quantitative data will provide a general overview of the intervention's efficacy and limitations, and the qualitative data will help to explain these findings by exploring participants' experiences and perspectives in more depth.
- Conditions
- Prediabetic State, Diabetes Mellitus
- Being tested
- JOOL Health Mobile Phone Application
- Keywords
- Prevention, Mobile health, Autonomous motivation
- Medical subject headings
- Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOOL Health Mobile Phone ApplicationDevice
JOOL Health is a mobile phone-based application that aims to increase autonomous motivation to prevent T2DM by helping individuals make connections between certain health behaviors and the energy and willpower needed to achieve personal goals. On a daily basis, JOOL Health users chart the following health behaviors: Sleep, Presence, Activity, Creativity, and Eating. On a weekly basis, JOOL Health users are asked to record how well they lived according to their purpose and values. Through the integration of user-entered information with contextual data, JOOL Health provides tailored messaging and daily predictions of individuals' energy and willpower.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes as well as a list of resources for mHealth tools for monitoring diet, physical activity, and weight. |
| JOOL-Only | Experimental | Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, and will receive the JOOL Health mobile phone application. Receives: Device: JOOL Health Mobile Phone Application |
| JOOL-Plus | Experimental | Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, the JOOL Health mobile phone application, a digital scale, and a Fitbit. Receives: Device: JOOL Health Mobile Phone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Autonomous Motivation to Prevent T2DM
Change from baseline mean score on a scale of 1 - 7 as assessed by the Treatment Self Regulation Questionnaire- Autonomous Section survey instrument where 1 means little autonomous motivation and 7 means high autonomous motivation.
Measured: 12 Weeks
Secondary outcomes (3)
Change in self-reported weight
Measured: Baseline to 12-week follow-up
Change in HbA1c
Measured: Baseline to 12-week follow-up
Change in psychosocial measures
Overall motivation to prevent T2DM; purpose in life; perceived competence to prevent T2DM; social support; eating behavior; self-reported physical activity; patient activation; willingness to participate in a Diabetes Prevention Program
Measured: Baseline to 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start3 May 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Mary Ellen Michele Heisler, University of Michigan
- Investigators
- Dina Griauzde, MD, Study director, Robert Wood Johnson Clinical Scholars Program (VA Scholar)Michele Heisler, MD, Principal investigator, Robert Wood Johnson Clinical Scholars Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025607
- Sponsor's protocol ID
- 2420.PIRAP
- Status last verified
- Apr 2018
- First submitted
- 16 Jan 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griauzde D, Kullgren JT, Liestenfeltz B, Ansari T, Johnson EH, Fedewa A, Saslow LR, Richardson C, Heisler M. A Mobile Phone-Based Program to Promote Healthy Behaviors Among Adults With Prediabetes Who Declined Participation in Free Diabetes Prevention Programs: Mixed-Methods Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 9;7(1):e11267. doi: 10.2196/11267.
PubMed 30626566Griauzde DH, Kullgren JT, Liestenfeltz B, Richardson C, Heisler M. A mobile phone-based program to promote healthy behaviors among adults with prediabetes: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2018 Feb 13;4:48. doi: 10.1186/s40814-018-0246-z. eCollection 2018.
PubMed 29449958
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Pilot Randomized Controlled Trial of a Mobile Phone-based Health Program Among Adults With Prediabetes
- ClinicalTrials.gov ID
- NCT03025607
- Acronym / sponsor ID
- 2420.PIRAP
- Conditions
- Prediabetic State, Diabetes Mellitus
- Keywords
- Prevention, Mobile health, Autonomous motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- 3 May 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 19 Jan 2017 (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.
Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical activity, yet its prevalence continues to rise. This trend may be due in part to low rates of participation in evidence-based lifestyle change programs such as the Diabetes Prevention Program (DPP). New strategies are needed to promote healthy behaviors among individuals at risk for T2DM, and mobile health technologies may be an effective and scalable approach to achieve this. One promising tool is JOOL Health, a mobile phone-based application that leverages principles from Self-Determination Theory to help individuals understand how certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue their core values and purpose in life. Through personalized messaging and feedback, JOOL Health aims to increase autonomous motivation, a form of motivation closely associated with the initiation and maintenance of healthy behaviors.
In this mixed methods pilot randomized controlled trial, the investigators will test whether the JOOL Health mobile phone-based application -- used alone and in conjunction with other mobile health technologies to track weight and physical activity -- can increase autonomous motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who previously declined participation in a Diabetes Prevention Program (DPP).
Detailed description
This 12-week pilot randomized controlled trial aims to recruit 156 individuals with prediabetes who declined participation in a formal DPP despite invitation to participate at no out-of-pocket cost by their health plan. Participants will be randomized to 1 of 3 study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to diabetes, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (control group); (2) a group that receives the JOOL Health mobile phone application; and (3) a group that receives the JOOL Health mobile phone application and other mHealth tools (e.g. Fitbit activity tracker and wireless-enabled scale) whose results can be uploaded into JOOL.
The investigators will use a mixed methods approach with a sequential explanatory design, which is to say that quantitative data and qualitative data will be collected in 2 consecutive phases within the study. Specifically, in the first phase, investigators will collect and analyze qualitative data (e.g. focus groups) from a purposive sample of participants with differing levels of engagement and success. The rationale for this approach is that the quantitative data will provide a general overview of the intervention's efficacy and limitations, and the qualitative data will help to explain these findings by exploring participants' experiences and perspectives in more depth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes as well as a list of resources for mHealth tools for monitoring diet, physical activity, and weight. |
| JOOL-Only | Experimental | Device: JOOL Health Mobile Phone ApplicationParticipants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, and will receive the JOOL Health mobile phone application. |
| JOOL-Plus | Experimental | Device: JOOL Health Mobile Phone ApplicationParticipants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, the JOOL Health mobile phone application, a digital scale, and a Fitbit. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Invited to participate in a DPP by the participant's health plan, but have not engaged in a program at least 6 months after receiving the first letter of invitation
- Wireless internet access
- Personal smartphone access
Key exclusion criteria (4 listed)
- Individuals currently participating in another lifestyle or behavior change program or research study
- Inability to read, write, or speak English
- Inability to provide informed consent
- Women who are pregnant or intend to become pregnant during the intervention period
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 |
|---|---|---|
| JOOL Health Mobile Phone ApplicationJOOL Health is a mobile phone-based application that aims to increase autonomous motivation to prevent T2DM by helping individuals make connections between certain health behaviors and the energy and willpower needed to achieve personal goals. On a daily basis, JOOL Health users chart the following health behaviors: Sleep, Presence, Activity, Creativity, and Eating. On a weekly basis, JOOL Health users are asked to record how well they lived according to their purpose and values. Through the integration of user-entered information with contextual data, JOOL Health provides tailored messaging and daily predictions of individuals' energy and willpower. | Device | JOOL-Only, JOOL-Plus |
Primary outcome
Change in Autonomous Motivation to Prevent T2DM
Time frame: 12 Weeks
Change from baseline mean score on a scale of 1 - 7 as assessed by the Treatment Self Regulation Questionnaire- Autonomous Section survey instrument where 1 means little autonomous motivation and 7 means high autonomous motivation.
3 secondary outcomes
Change in self-reported weight
Time frame: Baseline to 12-week follow-up
Change in HbA1c
Time frame: Baseline to 12-week follow-up
Change in psychosocial measures
Time frame: Baseline to 12-week follow-up
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 19 Apr 2018.
- Derived from this study: PubMed 30626566Griauzde D, Kullgren JT, Liestenfeltz B, Ansari T, Johnson EH, Fedewa A, Saslow LR, Richardson C, Heisler M. A Mobile Phone-Based Program to Promote Healthy Behaviors Among Adults With Prediabetes Who Declined Participation in Free Diabetes Prevention Programs: Mixed-Methods Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 9;7(1):e11267. doi: 10.2196/11267.
- Derived from this study: PubMed 29449958Griauzde DH, Kullgren JT, Liestenfeltz B, Richardson C, Heisler M. A mobile phone-based program to promote healthy behaviors among adults with prediabetes: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2018 Feb 13;4:48. doi: 10.1186/s40814-018-0246-z. eCollection 2018.
- 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.
Dina Griauzde, MD study director
Robert Wood Johnson Clinical Scholars Program (VA Scholar)
Michele Heisler, MD principal investigator
Robert Wood Johnson Clinical Scholars Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JOOL Health Mobile Phone Application in people with Prediabetic State and Diabetes Mellitus, run by University of Michigan 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 3 inclusion and 4 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 19 Apr 2018. 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?
Change in Autonomous Motivation to Prevent T2DM (time frame: 12 Weeks). 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 NCT03025607, which also lists 2 linked publications.
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 19 Apr 2018.