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

Study Overview
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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 24-week 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 24-week trial.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Adapted Look Ahead Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: A pre-post-test study to assess the implementation outcomes and preliminary health responses
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention group<br>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<br>* Participants will be educated about improving healthy lifestyles involving physical activity and healthy eating to improve physical function and improve glycemic control.<br>* Other names: Multilevel Lifestyle Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | 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 to 24 weeks | 
| 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. | 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Measured in pounds with participant in light clothes and without shoes | Baseline, 12 weeks and 24 weeks | 
| Systolic Blood Pressure | Sitting blood pressure will be measured after at least five minutes of rest. | Baseline, 12 weeks and 24 weeks | 
| Diastolic Blood Pressure | Sitting blood pressure will be measured after at least five minutes of rest. | Baseline, 12 weeks and 24 weeks | 
| 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, 12 weeks and 24 weeks | 
| Grip Strength | Grip strength will be measured in both hands, and the dominant hand will be recorded. | Baseline, 12 weeks and 24 weeks | 
| 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, 12 weeks and 24 weeks | 
| 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, 12 weeks and 24 weeks | 
| 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, 12 weeks and 24 weeks | 
| 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, 12 weeks and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evidence based lifestyle intervention, Older Adults, Physical Function, Glycemic control