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

NCT ID: NCT06173804

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-22

Study Completion Date

2026-05-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Keywords

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Evidence based lifestyle intervention Older Adults Physical Function Glycemic control

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A pre-post-test study to assess the implementation outcomes and preliminary health responses
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Adapted Look Ahead Lifestyle Intervention

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Multilevel Lifestyle Intervention

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Du, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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University Health System Texas Diabetic Institute

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00000013

Identifier Type: -

Identifier Source: org_study_id