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

NCT06173804 | Active Not Recruiting

• 1 other identifier: STUDY00000013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 2 Diabetes

Keywords

Evidence based lifestyle intervention; Older Adults; Physical Function; Glycemic control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Body Weight

  Baseline, 3, 6, and 12 months

• Systolic Blood Pressure

  Baseline, 3, 6, and 12 months

• Diastolic Blood Pressure

  Baseline, 3, 6, and 12 months

• Short Physical Performance Battery (SPPB)

  Baseline, 3, 6, and 12 months

• Grip Strength

  Baseline, 3, 6, and 12 months

Study Arms (1)

Lifestyle intervention group

EXPERIMENTAL

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

Interventions

Adapted Look Ahead Lifestyle Intervention OTHER

Participants will be educated about improving healthy lifestyles involving physical activity and healthy eating to improve physical function and improve glycemic control.

Also known as: Multilevel Lifestyle Intervention

Lifestyle intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥60 years
• Self-reported T2D diagnosis with verification from a health report
• Live within the census tract of the selected senior center, or a member of the senior center
• No significant cognitive impairment as defined by MMSE (score≥20) (46) which may influence diabetes self-management
• Can speak and understand either English or Spanish
• Agree to participate in the study procedures

You may not qualify if:

• Severe chronic conditions without physician's permission to participate (e.g., severe heart disease and end-stage renal disease);
• Unwillingness to sign the consent form; and
• Enrollment in other diabetes management programs

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Health System Texas Diabetic Institute

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yan Du, PhD, MPH

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pre-post-test study to assess the implementation outcomes and preliminary health responses

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 18, 2023
• Study Start: July 22, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data may be shared after peer-reviewed journal publication after study completion or as summary results on ClinicalTrials.gov

Locations

US (1)