Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities

Type 2 Diabetes Clinical Trial

Official title:

Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06049225
• Other study ID #: IRB-300010728
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Anita Aboagye
• Phone: 857-453-9502
• Email: aboagyea[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Physical Disability
• Type 2 Diabetes

Intervention

Behavioral:
• High-Tech
Access to technological platform and weekly health coaching
• Low-Tech
Weekly email with educational content and weekly health coaching
• Attention Control
No technology access or health coaching

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity	Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome	24 weeks
Other	Dietary intake	Measured using The US version of the Diabetes and Diet Questionnaire	24 weeks
Other	Medication Adherence	Measured using the Medication Adherence Rating Scale	24 weeks
Other	Health Dashboard Usability	Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes	24 weeks
Primary	Diabetes Quality of Life	Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome	24 weeks
Primary	Psychological Distress	Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome	234 weeks
Primary	Self-efficacy	Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome	24 weeks
Secondary	Glycemic Management	Measured using HbA1c	24 weeks