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

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Other: Adapted Look Ahead Lifestyle Intervention

• Registration Number: NCT06173804
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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).

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 Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-18
• Study Start: 2024-07-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-07-22
• Study Completion: 2025-07-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention group	Adapted Look Ahead Lifestyle Intervention	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).

Primary Outcome Measures

Name	Time	Method
Feasibility of conducting study	Baseline, 3, 6, and 12 months	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.
Acceptability	Baseline, 3, 6, and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Body Weight	Baseline, 3, 6, and 12 months	Measured in pounds with participant in light clothes and without shoes
Systolic Blood Pressure	Baseline, 3, 6, and 12 months	Sitting blood pressure will be measured after at least five minutes of rest.
Diastolic Blood Pressure	Baseline, 3, 6, and 12 months	Sitting blood pressure will be measured after at least five minutes of rest.
Short Physical Performance Battery (SPPB)	Baseline, 3, 6, and 12 months	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.
Grip Strength	Baseline, 3, 6, and 12 months	Grip strength will be measured in both hands, and the dominant hand will be recorded.
Glycated Hemoglobin (HbA1c)	Baseline, 3, 6, and 12 months	HbA1c is a blood test that is used to assess and monitor the average level of glucose over the past two to three months.
Lipid profile	Baseline, 3, 6, and 12 months	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.
IPAQ-12	Baseline, 3, 6, and 12 months	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.
MoCA	Baseline, 3, 6, and 12 months	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.

Trial Locations

Locations (1)

University Health System Texas Diabetic Institute; 🇺🇸 San Antonio, Texas, United States