Type 2 DiabetesSTRIDENCT07210593
STrong Relationships to Improve DiabEtes Pilot
A study testing FAMS and PEER in people with Type 2 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This is a pilot and feasibility study for a mobile phone-delivered intervention, called STRIDE (STrong Relationships to Improve DiabEtes), designed to provide support for adults with type 2 diabetes (improve glycemic management and social support). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- FAMS and PEER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PERSONS WITH DIABETES:
- Speaks and reads in English
- 18-75 years old
- Diagnosed with type 2 diabetes
- Receiving outpatient care from a partnering clinic
- Community-dwelling (e.g., not in a nursing facility)
Show all 14Show fewer
- Prescribed at least one daily diabetes medication
- Owns a mobile phone
- Elevated diabetes distress or low diabetes self-efficacy
- Willing to invite a close friend or family member to co-participate
- SUPPORT PERSONS:
- Speaks and reads in English
- 18 years or older
- Owns a mobile phone
Who cannot join
- PERSONS WITH DIABETES
- Unable to communicate by phone
- Currently pregnant
- Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
- Diagnosed with end-stage renal disease
- Receiving hospice services
Show all 13Show fewer
- Diagnosed with congestive heart failure
- Diagnosed with dementia
- Diagnosed with schizophrenia
- Demonstrated an inability to receive and respond to a text
- Does not take medication on his/her own/medication administered by someone else SUPPORT PERSONS
- Demonstrated inability to receive \& respond to a text
- Unable to communicate by phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: STrong Relationships to Improve DiabEtes (STRIDE) Pilot
This is a pilot and feasibility study for a mobile phone-delivered intervention, called STRIDE (STrong Relationships to Improve DiabEtes), designed to provide support for adults with type 2 diabetes (improve glycemic management and social support). The goal of the study is to examine the feasibility and acceptability of STRIDE.
- Conditions
- Type 2 Diabetes
- Being tested
- FAMS, PEER
- Keywords
- type 2 diabetes, SMART
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAMSBehavioural
PWD participants will receive FAMS components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment.
Co-enrolled SP participants will receive high-quality print materials upon enrollment and receive text message support tailored to the goal set by the linked PWD.
PEERBehavioural
PWD participants will receive PEER components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment PWD participants assigned to PEER will be matched with another PWD participant assigned to peer to provide peer support to each other.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Step 1: Optimal First Line Treatment | Experimental | Persons with diabetes (PWD) participants will first be randomized to an optimal first line treatment in order to compare FAMS vs. PEER. PWD participants assigned to Step 1 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD. PWD participants assigned to Step 1 treatment "PEER" will be paired with another participant to provide each other peer support. Receives: Behavioral: FAMS; Behavioral: PEER |
| Experimental: Step 2: Optimal Second Line Treatment | Experimental | All PWD participants will be randomized at month 3 to FAMS or PEER. PWD participants assigned to Step 2 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD if not previously enrolled. PWD participants assigned to Step 2 treatment "PEER" will be paired with another participant to provide each other peer support. If they had previously enrolled a SP, the SP participant will stop receiving text messages. Receives: Behavioral: FAMS; Behavioral: PEER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score >0) indicate good acceptability
Measured: 6 months post-baseline
Feasibility (Recruitment)
Number of participants screened/week
Measured: baseline
Feasibility (Recruitment)
Proportion of eligible screens who enroll
Measured: baseline
Feasibility (Treatment Adherence)
Proportion of sessions attended
Measured: 6 months post-baseline
Feasibility (Treatment Adherence)
Proportion of interactive texts with response
Measured: 6 months post-baseline
Feasibility (Assessment Completion)
Proportion of self-report measures completed
Measured: 3 and 6 months post-baseline
Secondary outcomes (4)
Change in Hemoglobin A1c
Hemoglobin A1c assessed by mail-in A1c kits from BioQuintex and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management
Measured: Baseline and 3 and 6 months post-baseline
Change in Diabetes Distress
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse)
Measured: Baseline and 3 and 6 months post-baseline
Change in Psychosocial Well-being
Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)
Measured: Baseline and 3 and 6 months post-baseline
Change in Social Support for Diabetes
Assessed by the Diabetes Support Scale (DSS) with scores ranging 12 to 84 where higher scores indicate more social support for diabetes (better)
Measured: Baseline and 3 and 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start15 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, McKenzie Roddy, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210593
- Sponsor's protocol ID
- 250845
- Other IDs
- K23DK140531
- Acronym
- STRIDE
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study results are posted on clinical trials, de-identified individual and aggregate survey, clinical, and laboratory data (including raw and recoded data) and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be made publicly available through the Open Science Framework (OSF).
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STrong Relationships to Improve DiabEtes (STRIDE) Pilot
- ClinicalTrials.gov ID
- NCT07210593
- Acronym / sponsor ID
- STRIDE / 250845
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, SMART
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- 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 is a pilot and feasibility study for a mobile phone-delivered intervention, called STRIDE (STrong Relationships to Improve DiabEtes), designed to provide support for adults with type 2 diabetes (improve glycemic management and social support). The goal of the study is to examine the feasibility and acceptability of STRIDE.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Experimental: Step 1: Optimal First Line Treatment | Experimental | Behavioral: FAMS, Behavioral: PEERPersons with diabetes (PWD) participants will first be randomized to an optimal first line treatment in order to compare FAMS vs. PEER. PWD participants assigned to Step 1 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD. PWD participants assigned to Step 1 treatment "PEER" will be paired with another participant to provide each other peer support. |
| Experimental: Step 2: Optimal Second Line Treatment | Experimental | Behavioral: FAMS, Behavioral: PEERAll PWD participants will be randomized at month 3 to FAMS or PEER. PWD participants assigned to Step 2 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD if not previously enrolled. PWD participants assigned to Step 2 treatment "PEER" will be paired with another participant to provide each other peer support. If they had previously enrolled a SP, the SP participant will stop receiving text messages. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Speaks and reads in English
- 18-75 years old
- Diagnosed with type 2 diabetes
- Receiving outpatient care from a partnering clinic
- Community-dwelling (e.g., not in a nursing facility)
Key exclusion criteria (13 listed)
- PERSONS WITH DIABETES
- Unable to communicate by phone
- Currently pregnant
- Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
- Diagnosed with end-stage renal disease
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 |
|---|---|---|
| FAMSPWD participants will receive FAMS components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment. Co-enrolled SP participants will receive high-quality print materials upon enrollment and receive text message support tailored to the goal set by the linked PWD. | Behavioural | Experimental: Step 1: Optimal First Line Treatment, Experimental: Step 2: Optimal Second Line Treatment |
| PEERPWD participants will receive PEER components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment PWD participants assigned to PEER will be matched with another PWD participant assigned to peer to provide peer support to each other. | Behavioural | Experimental: Step 1: Optimal First Line Treatment, Experimental: Step 2: Optimal Second Line Treatment |
Primary outcome
Acceptability
Time frame: 6 months post-baseline
Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score >0) indicate good acceptability
Feasibility (Recruitment)
Time frame: baseline
Number of participants screened/week
Feasibility (Recruitment)
Time frame: baseline
Proportion of eligible screens who enroll
Feasibility (Treatment Adherence)
Time frame: 6 months post-baseline
Proportion of sessions attended
Feasibility (Treatment Adherence)
Time frame: 6 months post-baseline
Proportion of interactive texts with response
Feasibility (Assessment Completion)
Time frame: 3 and 6 months post-baseline
Proportion of self-report measures completed
4 secondary outcomes
Change in Hemoglobin A1c
Time frame: Baseline and 3 and 6 months post-baseline
Change in Diabetes Distress
Time frame: Baseline and 3 and 6 months post-baseline
Change in Psychosocial Well-being
Time frame: Baseline and 3 and 6 months post-baseline
Change in Social Support for Diabetes
Time frame: Baseline and 3 and 6 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. After study results are posted on clinical trials, de-identified individual and aggregate survey, clinical, and laboratory data (including raw and recoded data) and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be made publicly available through the Open Science Framework (OSF).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAMS and PEER in people with Type 2 Diabetes, run by Vanderbilt University Medical Center 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 14 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acceptability (time frame: 6 months post-baseline). The study lists 6 primary outcomes in all. 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 31 Aug 2026.