Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Diabetes Self-Management Lifestyle Intervention for Urban Minority Young Adults
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).
n/a
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