Multilevel Lifestyle Intervention to Improve Physical Function in Older Adults With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— RESILIENT  

Official title:

A Senior Center-Based Multilevel Lifestyle Intervention to Improve Physical Function in Older Adults With Type 2 Diabetes (RESILIENT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06173804
• Other study ID #: STUDY00000013
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Yan Du, PhD, MPH
• Phone: 210-567-2170
• Email: duy[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore strategies to effectively implement senior-center-based multilevel lifestyle interventions adapted from evidence-based lifestyle interventions to promote physical function and quality of life in diverse older adults with Type 2 Diabetes (T2D).

Description:

Aim 1: Work with community stakeholders including individuals with T2D, family members, and senior center staff to adapt evidence-based lifestyle interventions, and develop implementation strategies.

Aim 2: Conduct a senior-center-based 24-week pre- and post-pilot study and collect recruitment, enrollment, retention rate, fidelity, program satisfaction and experience, and stakeholder acceptance using quantitative and qualitative data.

Aim 3: Assess the preliminary health-related responses to the intervention in older adults with T2D in the 24-week trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Adults aged =60 years

2. Self-reported T2D diagnosis with verification from a health report

3. Live within the census tract of the selected senior center, or a member of the senior center

4. No significant cognitive impairment as defined by MMSE (score=20) (46) which may influence diabetes self-management

5. Can speak and understand either English or Spanish

6. Agree to participate in the study procedures

Exclusion Criteria:

1. Severe chronic conditions without physician's permission to participate (e.g., severe heart disease and end-stage renal disease);

2. Unwillingness to sign the consent form; and

3. Enrollment in other diabetes management programs

Related Conditions & MeSH terms

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

Intervention

Other:
• Adapted Look Ahead Lifestyle Intervention
Participants will be educated about improving healthy lifestyles involving physical activity and healthy eating to improve physical function and improve glycemic control.

Locations

Country	Name	City	State
United States	University Health System Texas Diabetic Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of conducting study	Feasibility refers to how feasible to conduct the study. In this study, feasibility will be assessed by data such as participant recruitment, enrollment, education session attendance, and retention rate.	Baseline to 24 weeks
Primary	Acceptability	Acceptability refers to how well an intervention will be received by the target population and the extent to which an intervention might meet the needs of the target population. Acceptability will be assessed through qualitative interview with participants to explore their experience, and perceptions with the intervention.	12 weeks and 24 weeks
Secondary	Body Weight	Measured in pounds with participant in light clothes and without shoes	Baseline, 12 weeks and 24 weeks
Secondary	Systolic Blood Pressure	Sitting blood pressure will be measured after at least five minutes of rest.	Baseline, 12 weeks and 24 weeks
Secondary	Diastolic Blood Pressure	Sitting blood pressure will be measured after at least five minutes of rest.	Baseline, 12 weeks and 24 weeks
Secondary	Short Physical Performance Battery (SPPB)	The SPPB is a series of physical tests used to assess a person's lower extremity function. SPPB scores range from zero to 12 possible points. A higher score indicated better physical performance.	Baseline, 12 weeks and 24 weeks
Secondary	Grip Strength	Grip strength will be measured in both hands, and the dominant hand will be recorded.	Baseline, 12 weeks and 24 weeks
Secondary	Glycated Hemoglobin (HbA1c)	HbA1c is a blood test that is used to assess and monitor the average level of glucose over the past two to three months.	Baseline, 12 weeks and 24 weeks
Secondary	Lipid profile	It is a blood test that measures the levels of fats and fatty substances in the blood. The following measurements in the profile will be assessed: cholesterol, LDL (low-density lipoprotein) cholesterol, HDL (high-density lipoprotein) cholesterol, and triglycerides.	Baseline, 12 weeks and 24 weeks
Secondary	IPAQ-12	This scale contains 12 items that are a self-reported measure of physical activity. Scores are typically expressed in minutes per week. Higher scores indicate higher levels of physical activity, whereas lower scores suggest sedentary or low activity levels.	Baseline, 12 weeks and 24 weeks
Secondary	MoCA	MoCA is a 30-point questionnaire that tests various cognitive domains, including memory, attention, language, abstraction, executive functions, visual skills, calculation, and orientation. The score ranges from 0-30, and higher score indicates better cognitive function.	Baseline, 12 weeks and 24 weeks