Resilient, Empowered, Active Living: REAL Diabetes Study

Summary

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).

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Resilient, Empowered, Active Living with Diabetes

Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive a total of 10-16 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the REAL Diabetes intervention protocol.

BEHAVIORAL

Information Control

Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose. The packet of materials will be delivered in an initial home visit. Follow-up phone calls will occur at approximately two week intervals to inquire whether participants have reviewed specific sections of the intervention materials, and clarify information included in the packet.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Southern California

  lead OTHER

Principal Investigators

• Elizabeth Pyatak, PhD, OTR/L · University of Southern California

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2016-06-30

Completion

2017-07-31

Countries

• United States

Study Locations