NCT04347291: FAMS 2

Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes

Completed NA Results posted Last updated 17 January 2024

What this trial tests

NA trial testing FAMS 2.0 in Type 2 Diabetes in 638 participants. Completed in 17 February 2023.

Timeline

28 April 2020

Primary endpoint
17 February 2023

17 February 2023

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	638
Start date	28 April 2020
Primary completion	17 February 2023
Estimated completion	17 February 2023
Sites	1 location across United States

Drugs / interventions tested

• FAMS 2.0
• Print Materials

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 75, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Glycemic Control (Patient Participants) During Intervention Period Primary · 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

Baseline

Group	Value	95% CI
FAMS 2.0	8.64	± 1.79
Print Materials	8.53	± 1.56

6 months

Group	Value	95% CI
FAMS 2.0	8.00	± 1.55
Print Materials	8.31	± 1.55

9 months

Group	Value	95% CI
FAMS 2.0	8.23	± 1.72
Print Materials	8.05	± 1.41

Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects Primary · 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

Baseline

Group	Value	95% CI
FAMS 2.0	8.64	± 1.79
Print Materials	8.53	± 1.56

12 months

Group	Value	95% CI
FAMS 2.0	7.99	± 1.55
Print Materials	8.04	± 1.41

15 months

Group	Value	95% CI
FAMS 2.0	8.21	± 1.62
Print Materials	8.04	± 1.40

Change in Diabetes Distress (Patient Participants) During Intervention Period Primary · 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)

Baseline

Group	Value	95% CI
FAMS 2.0	38.8	± 26.9
Print Materials	38.1	± 24.5

6 months

Group	Value	95% CI
FAMS 2.0	30.1	± 25.4
Print Materials	32.9	± 24.8

9 months

Group	Value	95% CI
FAMS 2.0	26.5	± 25.4
Print Materials	30.6	± 22.8

Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect Primary · 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)

Baseline

Group	Value	95% CI
FAMS 2.0	38.8	± 26.9
Print Materials	38.1	± 24.5

15 months

Group	Value	95% CI
FAMS 2.0	26.2	± 25.5
Print Materials	27.8	± 22.4

Change in Psychosocial Well-being (Patient Participants) During Intervention Period Primary · 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)

Baseline

Group	Value	95% CI
FAMS 2.0	55.6	± 23.4
Print Materials	56.5	± 23.1

6 months

Group	Value	95% CI
FAMS 2.0	62.5	± 23.2
Print Materials	57.5	± 22.9

9 months

Group	Value	95% CI
FAMS 2.0	62.2	± 22.2
Print Materials	61.4	± 22.2

Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect Primary · 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)

Baseline

Group	Value	95% CI
FAMS 2.0	55.6	± 23.4
Print Materials	56.5	± 23.1

15 months

Group	Value	95% CI
FAMS 2.0	62.0	± 23.1
Print Materials	65.3	± 23.0

Change in Diabetes Distress (Support Person Participants) During Intervention Period Secondary · Baseline and 6 and 9 months post-baseline

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)

Baseline

Group	Value	95% CI
FAMS 2.0	34.2	± 22.2
Print Materials	31.4	± 21.6

6 months

Group	Value	95% CI
FAMS 2.0	31.9	± 22.4
Print Materials	28.4	± 20.1

9 months

Group	Value	95% CI
FAMS 2.0	30.2	± 21.8
Print Materials	28.3	± 22.2

Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect Secondary · Baseline and 15 months post-baseline

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)

Baseline

Group	Value	95% CI
FAMS 2.0	34.2	± 22.2
Print Materials	31.4	± 21.6

15 months

Group	Value	95% CI
FAMS 2.0	28.9	± 22.5
Print Materials	27.8	± 20.7

Change in Support Burden (Support Person Participants) During Intervention Period Secondary · Baseline and 6 and 9 months post-baseline

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)

Baseline

Group	Value	95% CI
FAMS 2.0	0.392	± 0.760
Print Materials	0.360	± 0.674

6 months

Group	Value	95% CI
FAMS 2.0	0.341	± 0.690
Print Materials	0.368	± 0.746

9 months

Group	Value	95% CI
FAMS 2.0	0.392	± 0.710
Print Materials	0.366	± 0.716

Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect Secondary · Baseline and 15 months post-baseline

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)

Baseline

Group	Value	95% CI
FAMS 2.0	0.392	± 0.760
Print Materials	0.360	± 0.674

15 months

Group	Value	95% CI
FAMS 2.0	0.301	± 0.664
Print Materials	0.368	± 0.750

Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) Secondary · Baseline and 6 and 9 months post-baseline

as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better)

Baseline

Group	Value	95% CI
FAMS 2.0	25.7	± 6.74
Print Materials	25.0	± 6.41

6 months

Group	Value	95% CI
FAMS 2.0	29.6	± 6.85
Print Materials	26.4	± 6.74

9 months

Group	Value	95% CI
FAMS 2.0	30.2	± 6.65
Print Materials	27.8	± 6.50

Change in Dietary Behavior (Patient Participants - Outcome & Mediator) Secondary · Baseline and 6, 9, and 15 months post-baseline

as assessed by Personal Diabetes Questionnaire, Use of Information for Decision Making Scale with scores ranging 1-6 where higher scores indicate more use of dietary information for decision making (better)

Baseline

Group	Value	95% CI
FAMS 2.0	3.00	± 1.53
Print Materials	3.15	± 1.48

6 months

Group	Value	95% CI
FAMS 2.0	3.43	± 1.61
Print Materials	3.40	± 1.45

9 months

Group	Value	95% CI
FAMS 2.0	3.64	± 1.49
Print Materials	3.37	± 1.43

15 months

Group	Value	95% CI
FAMS 2.0	3.30	± 1.43
Print Materials	3.31	± 1.42

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Mayberry LS, El-Rifai M, Nelson LA, Parks M, et al · · 2022 · cited 13× · PMID 36208719 · DOI 10.1016/j.cct.2022.106956
2. Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.
   Roddy MK, Spieker AJ, Nelson LA, Greevy RA, et al · · 2023 · cited 9× · PMID 37742801 · DOI 10.1016/j.diabres.2023.110921
3. Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.
   Nelson LA, Spieker AJ, Greevy RA, Roddy MK, et al · · 2023 · cited 8× · PMID 37925077 · DOI 10.1016/j.diabres.2023.110991
4. The Goldilocks Dilemma on Balancing User Response and Reflection in mHealth Interventions: Observational Study.
   Nelson LA, Spieker AJ, LeStourgeon LM, Greevy RA, et al · · 2024 · cited 2× · PMID 38297891 · DOI 10.2196/47632
5. Diabetes-specific family functioning typology associated with intervention engagement and effects: secondary analyses from a randomized controlled trial.
   Roddy MK, Spieker AJ, Greevy RA, Nelson LA, et al · · 2025 · cited 1× · PMID 39661957 · DOI 10.1093/abm/kaae070
6. A qualitative analysis of family experiences across diabetes-specific family functioning types during a family-focused intervention for adults with type 2 diabetes.
   Roddy MK, Bergner EM, Berg CA, Mayberry LS. · · 2025 · PMID 40813845 · DOI 10.1007/s10865-025-00594-7
7. Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant.
   Roddy MK, El-Rifai M, LeStourgeon L, Aikens JE, et al · · 2025 · PMID 37750180 · DOI 10.1177/17423953231203734