Resilient, Empowered, Active Living: REAL Diabetes Study
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About
This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assessment, principles of an evidence-based occupational therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. The study will randomize 80 young adults with diabetes to receive either the six-month REAL intervention or an attention control condition. Blinded data collectors will assess glycemic control, diabetes self-care behaviors and quality of life outcomes, as well as potential intervention mediators, before and after the six-month intervention. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention.
The study's specific aims and hypotheses are as follows:
Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care.
Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants.
Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT).
Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants.
Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in potential mediators of the intervention: habit strength, problem solving, activity participation, self-efficacy and diabetes knowledge as compared to baseline.
Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol).
Enrollment
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Inclusion criteria
- Diagnosed with type 1 or type 2 diabetes mellitus for a minimum of 12 months
- Most recent A1C ≥8.0%
- Fluent in English or Spanish
- Reachable by telephone or text message
- Willing to participate in study activities
- Reside in Los Angeles County with no plans to relocate
Exclusion criteria
- Pregnant or planning to become pregnant
- Cognitive impairment or severe disability limiting life expectancy
- Participated in lifestyle intervention targeting diabetes within past 12 months
- Participated in formative research related to intervention development.
Trial design
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81 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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