Type 2 DiabetesFAMS 2NCT04347291
Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
A study testing FAMS 2.0 and Print Materials in people with Type 2 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. 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 2.0 and Print Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 638 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- PATIENTS:
- 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 12Show fewer
- Prescribed at least one daily diabetes medication
- Owns a mobile phone
- SUPPORT PERSONS:
- Speaks and reads in English
- 18 years or older
- Owns a mobile phone
Who cannot join
- PATIENTS:
- Unable to communicate by phone
- Pregnant currently
- Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
- Diagnosed with end-stage renal disease
- Receiving hospice services
Show all 14Show fewer
- Diagnosed with congestive heart failure
- Diagnosed with dementia
- Diagnosed with schizophrenia
- Reported current abuse during screening
- Demonstrates inability to receive and respond to a text
- Does not take medication on his/her own/medication administered by someone else
- SUPPORT PERSONS:
- Demonstrates inability to receive and respond to a text
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.
Read the detailed description
The 9-month FAMS 2.0 intervention is an expansion and improvement of a previously evaluated intervention (FAMS; NCT02481596). FAMS components include:
- Monthly coaching sessions (20-30 minutes each) with patient participants by phone focusing on helpful/unhelpful/desired family and friend behaviors relevant to the patients' self-identified diet, exercise, and/or stress management goal
- Daily one-way and interactive text messages to the patient to support him/her in meeting the identified daily goal and medication adherence
- Weekly interactive text messages asking the patient to reflect on goal progress followed by personalized feedback from the coach
- The option to invite an adult support person to receive text messages (3 one-way per week and one interactive text per week) encouraging the support person to discuss the patient's self-care goal to provide opportunities for the patient to practice skills discussed during phone coaching
Participants will be randomized in a parallel design to either FAMS 2.0 or an active control. Our target enrollment is N=334 dyads (patient participants and support persons). Patients are encouraged to invite a support person, but it is not required. Patients and their support person will be randomized together (if enrolled). The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects at 9 months (post-intervention) and 15 months (sustained effects). The investigators will impute missing data, including all participants completing at least two data collection periods in analyses. Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals).
- Conditions
- Type 2 Diabetes
- Being tested
- FAMS 2.0, Print Materials
- Keywords
- family support, social support, text message, mobile health, hemoglobin A1c
- 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.
FAMS 2.0Behavioural
Also called Family/friend Activation to Motivate Self-care, (prior iteration) Family-focused Add-on to Motivate Self-care (NCT02481596)
FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled.
Print MaterialsBehavioural
Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
| Study group | Role | What they receive |
|---|---|---|
| FAMS 2.0 | Experimental | Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant.
All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Receives: Behavioral: FAMS 2.0; Behavioral: Print Materials |
| Print Materials | Placebo comparator | All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Receives: Behavioral: Print Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycemic Control (Patient Participants) During Intervention Period
Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control
Measured: Baseline and 6 and 9 months post-baseline
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects
Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control
Measured: Baseline and 12 and 15 months post-baseline
Change in Diabetes Distress (Patient Participants) During Intervention Period
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)
Measured: Baseline and 6 and 9 months post-baseline
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)
Measured: Baseline and 15 months post-baseline
Change in Psychosocial Well-being (Patient Participants) During Intervention Period
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 6 and 9 months post-baseline
Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect
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 and15 months post-baseline
Secondary outcomes (4)
Change in Diabetes Distress (Support Person Participants) During Intervention Period
as assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 where higher scores indicate more diabetes distress experienced by the support person (worse)
Measured: Baseline and 6 and 9 months post-baseline
Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect
Assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 with higher scores indicate more diabetes distress experienced by the support person (worse)
Measured: Baseline and 15 months post-baseline
Change in Support Burden (Support Person Participants) During Intervention Period
as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where higher scores indicate greater support burden (worse)
Measured: Baseline and 6 and 9 months post-baseline
Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect
as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 100 where higher scores indicate greater support burden (worse)
Measured: Baseline and 15 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 posted15 Apr 2020
- Study start28 Apr 2020
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Mayberry, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347291
- Sponsor's protocol ID
- 200398
- Other IDs
- R01DK119282
- Acronym
- FAMS 2
- Status last verified
- Dec 2023
- First submitted
- 30 Mar 2020
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
Publications
Roddy MK, Spieker AJ, Greevy RA Jr, Nelson LA, Berg C, Mayberry LS. Diabetes-specific family functioning typology associated with intervention engagement and effects: secondary analyses from a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae070. doi: 10.1093/abm/kaae070.
PubMed 39661957Nelson LA, Spieker AJ, LeStourgeon LM, Greevy RA Jr, Molli S, Roddy MK, Mayberry LS. The Goldilocks Dilemma on Balancing User Response and Reflection in mHealth Interventions: Observational Study. JMIR Mhealth Uhealth. 2024 Jan 19;12:e47632. doi: 10.2196/47632.
PubMed 38297891Roddy MK, El-Rifai M, LeStourgeon L, Aikens JE, Wolever RQ, Greevy RA, Mayberry LS. Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant. Chronic Illn. 2025 Mar;21(1):105-114. doi: 10.1177/17423953231203734. Epub 2023 Sep 26.
PubMed 37750180Mayberry LS, El-Rifai M, Nelson LA, Parks M, Greevy RA Jr, LeStourgeon L, Molli S, Bergner E, Spieker A, Aikens JE, Wolever RQ. Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons. Contemp Clin Trials. 2022 Nov;122:106956. doi: 10.1016/j.cct.2022.106956. Epub 2022 Oct 5.
PubMed 36208719
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
- ClinicalTrials.gov ID
- NCT04347291
- Acronym / sponsor ID
- FAMS 2 / 200398
- Conditions
- Type 2 Diabetes
- Keywords
- family support, social support, text message, mobile health, hemoglobin A1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Posted 17 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.
Detailed description
The 9-month FAMS 2.0 intervention is an expansion and improvement of a previously evaluated intervention (FAMS; NCT02481596). FAMS components include:
- Monthly coaching sessions (20-30 minutes each) with patient participants by phone focusing on helpful/unhelpful/desired family and friend behaviors relevant to the patients' self-identified diet, exercise, and/or stress management goal
- Daily one-way and interactive text messages to the patient to support him/her in meeting the identified daily goal and medication adherence
- Weekly interactive text messages asking the patient to reflect on goal progress followed by personalized feedback from the coach
- The option to invite an adult support person to receive text messages (3 one-way per week and one interactive text per week) encouraging the support person to discuss the patient's self-care goal to provide opportunities for the patient to practice skills discussed during phone coaching
Participants will be randomized in a parallel design to either FAMS 2.0 or an active control. Our target enrollment is N=334 dyads (patient participants and support persons). Patients are encouraged to invite a support person, but it is not required. Patients and their support person will be randomized together (if enrolled). The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects at 9 months (post-intervention) and 15 months (sustained effects). The investigators will impute missing data, including all participants completing at least two data collection periods in analyses. Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAMS 2.0 | Experimental | Behavioral: FAMS 2.0, Behavioral: Print MaterialsPatient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. |
| Print Materials | Placebo comparator | Behavioral: Print MaterialsAll patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 (14 listed)
- Unable to communicate by phone
- Pregnant currently
- Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
- Diagnosed with end-stage renal disease
- Receiving hospice services
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 |
|---|---|---|
| FAMS 2.0Also: Family/friend Activation to Motivate Self-care, (prior iteration) Family-focused Add-on to Motivate Self-care (NCT02481596)FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. | Behavioural | FAMS 2.0 |
| Print MaterialsQuality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. | Behavioural | FAMS 2.0, Print Materials |
Primary outcome
Change in Glycemic Control (Patient Participants) During Intervention Period
Time frame: Baseline and 6 and 9 months post-baseline
Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects
Time frame: Baseline and 12 and 15 months post-baseline
Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control
Change in Diabetes Distress (Patient Participants) During Intervention Period
Time frame: Baseline and 6 and 9 months post-baseline
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect
Time frame: Baseline and 15 months post-baseline
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)
Change in Psychosocial Well-being (Patient Participants) During Intervention Period
Time frame: Baseline and 6 and 9 months post-baseline
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)
Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect
Time frame: Baseline and15 months post-baseline
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)
4 secondary outcomes
Change in Diabetes Distress (Support Person Participants) During Intervention Period
Time frame: Baseline and 6 and 9 months post-baseline
Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect
Time frame: Baseline and 15 months post-baseline
Change in Support Burden (Support Person Participants) During Intervention Period
Time frame: Baseline and 6 and 9 months post-baseline
Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect
Time frame: Baseline and 15 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39661957Roddy MK, Spieker AJ, Greevy RA Jr, Nelson LA, Berg C, Mayberry LS. Diabetes-specific family functioning typology associated with intervention engagement and effects: secondary analyses from a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae070. doi: 10.1093/abm/kaae070.
- Derived from this study: PubMed 38297891Nelson LA, Spieker AJ, LeStourgeon LM, Greevy RA Jr, Molli S, Roddy MK, Mayberry LS. The Goldilocks Dilemma on Balancing User Response and Reflection in mHealth Interventions: Observational Study. JMIR Mhealth Uhealth. 2024 Jan 19;12:e47632. doi: 10.2196/47632.
- Derived from this study: PubMed 37750180Roddy MK, El-Rifai M, LeStourgeon L, Aikens JE, Wolever RQ, Greevy RA, Mayberry LS. Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant. Chronic Illn. 2025 Mar;21(1):105-114. doi: 10.1177/17423953231203734. Epub 2023 Sep 26.
- Derived from this study: PubMed 36208719Mayberry LS, El-Rifai M, Nelson LA, Parks M, Greevy RA Jr, LeStourgeon L, Molli S, Bergner E, Spieker A, Aikens JE, Wolever RQ. Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons. Contemp Clin Trials. 2022 Nov;122:106956. doi: 10.1016/j.cct.2022.106956. Epub 2022 Oct 5.
- Individual participant dataSharing planned: Yes. After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
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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 2.0 and Print Materials 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 12 inclusion and 14 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 17 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Glycemic Control (Patient Participants) During Intervention Period (time frame: Baseline and 6 and 9 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?
On the ClinicalTrials.gov record for NCT04347291, which also lists 4 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 17 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.