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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Adapted Look Ahead Lifestyle Intervention

Detailed 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 6-month 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 6-month trial.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78207
      • University Health System Texas Diabetic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle intervention group; The study team will assess improvements in physical function assessed by the short physical performance battery and other health-related measures (diabetes knowledge, self-efficacy, social support, physical activity, diet consumption, HbA1c, and quality of life).	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.; Other Names: Multilevel Lifestyle Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 3, 6, and 12 months
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.	Baseline, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Measured in pounds with participant in light clothes and without shoes	Baseline, 3, 6, and 12 months
Systolic Blood Pressure	Sitting blood pressure will be measured after at least five minutes of rest.	Baseline, 3, 6, and 12 months
Diastolic Blood Pressure	Sitting blood pressure will be measured after at least five minutes of rest.	Baseline, 3, 6, and 12 months
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, 3, 6, and 12 months
Grip Strength	Grip strength will be measured in both hands, and the dominant hand will be recorded.	Baseline, 3, 6, and 12 months
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, 3, 6, and 12 months
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, 3, 6, and 12 months
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, 3, 6, and 12 months
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, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Yan Du, PhD, MPH, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2024
• Primary Completion (Actual): May 23, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Older Adults; Physical Function; Glycemic control; Evidence based lifestyle intervention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00000013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The deidentified quantitative data from the 15 participants such as demographics and clinical data could be shared upon request from the applicant after the study findings have been published in peer-reviewed journals.

The biospecimen collected at the senior center will be transported to the School of Nursing Biobehavioral Laboratory by the laboratory staff or the PI in a dry ice container on the same day of data collection.

• IPD Sharing Time Frame: Data may be shared after peer-reviewed journal publication after study completion or as summary results on ClinicalTrials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No