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Completed

NCT Number: NCT06173804

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

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health System Texas Diabetic Institute

San Antonio, Texas, 78207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Multilevel Lifestyle Intervention

Primary outcomes

  1. Feasibility of conducting study

    Time frame: 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.

  2. Acceptability

    Time frame: 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 outcomes

  1. Body Weight

    Time frame: Baseline, 3, 6, and 12 months

    Measured in pounds with participant in light clothes and without shoes

  2. Systolic Blood Pressure

    Time frame: Baseline, 3, 6, and 12 months

    Sitting blood pressure will be measured after at least five minutes of rest.

  3. Diastolic Blood Pressure

    Time frame: Baseline, 3, 6, and 12 months

    Sitting blood pressure will be measured after at least five minutes of rest.

  4. Short Physical Performance Battery (SPPB)

    Time frame: 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.

  5. Grip Strength

    Time frame: Baseline, 3, 6, and 12 months

    Grip strength will be measured in both hands, and the dominant hand will be recorded.

  6. Glycated Hemoglobin (HbA1c)

    Time frame: 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.

  7. Lipid profile

    Time frame: 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.

  8. IPAQ-12

    Time frame: 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.

  9. MoCA

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Acronym: RESILIENT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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