Clinical trial NCT06049225: Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
Official title: Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Physical Disability
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this project is to develop, and pilot test an accessible and inclusive medical nutrition therapy and diabetes self-management education program for people with Type 2 Diabetes and physical disabilities.

Detailed description: This study will use a three-arm randomized control trial design. Eligible and consented participants will be assigned to one of three groups: (1) intervention with high-tech support, (2) intervention with low-tech support, and (3) attention-control group. The active intervention period will include six months of weekly health coaching calls and technology access. The low-tech support group will receive six months of weekly coaching calls and weekly email containing related materials in PDF format but no video and technology content.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of T2DM
2. 18 to 65 years of age
3. Living with a permanent physical disability such as SCI, spina bifida, multiple sclerosis, stroke
4. Ability to converse in and read English
5. Availability of a smartphone or computer that can run apps
6. Have internet connection capabilities

Exclusion Criteria:

1. Current enrollment in any diabetes related intervention
2. Present or soon-planned pregnancy
3. Major heart attack or heart surgery in the past 12 months
4. Have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months
5. Severe cognitive impairment
6. Severe untreated depression in the past 6 months

Primary outcomes:
measure: Diabetes Quality of Life
timeFrame: 24 weeks
measure: Psychological Distress
timeFrame: 234 weeks
measure: Self-efficacy
timeFrame: 24 weeks
Secondary outcomes:
measure: Glycemic Management
timeFrame: 24 weeks
Other outcomes:
measure: Physical Activity
timeFrame: 24 weeks
measure: Dietary intake
timeFrame: 24 weeks
measure: Medication Adherence
timeFrame: 24 weeks
measure: Health Dashboard Usability
timeFrame: 24 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
citation: American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.
citation: Hall L, Colantonio A, Yoshida K. Barriers to nutrition as a health promotion practice for women with disabilities. Int J Rehabil Res. 2003 Sep;26(3):245-7. doi: 10.1097/00004356-200309000-00013.
citation: Kayes NM, Schluter PJ, McPherson KM, Taylor D, Kolt GS. The Physical Activity and Disability Survey -- Revised (PADS-R): an evaluation of a measure of physical activity in people with chronic neurological conditions. Clin Rehabil. 2009 Jun;23(6):534-43. doi: 10.1177/0269215508101750. Epub 2009 May 15.