Clinical trial NCT06173804: Multilevel Lifestyle Intervention to Improve Physical Function in Older Adults With Type 2 Diabetes
Official title: A Senior Center-Based Multilevel Lifestyle Intervention to Improve Physical Function in Older Adults With Type 2 Diabetes (RESILIENT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Evidence based lifestyle intervention
Older Adults
Physical Function
Glycemic control
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A pre-post-test study to assess the implementation outcomes and preliminary health responses
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of conducting study
timeFrame: Baseline, 3, 6, and 12 months
measure: Acceptability
timeFrame: Baseline, 3, 6, and 12 months
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline, 3, 6, and 12 months
measure: Systolic Blood Pressure
timeFrame: Baseline, 3, 6, and 12 months
measure: Diastolic Blood Pressure
timeFrame: Baseline, 3, 6, and 12 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, 3, 6, and 12 months
measure: Grip Strength
timeFrame: Baseline, 3, 6, and 12 months
measure: Glycated Hemoglobin (HbA1c)
timeFrame: Baseline, 3, 6, and 12 months
measure: Lipid profile
timeFrame: Baseline, 3, 6, and 12 months
measure: IPAQ-12
timeFrame: Baseline, 3, 6, and 12 months
measure: MoCA
timeFrame: Baseline, 3, 6, and 12 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Health System Texas Diabetic Institute
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Yan Du, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: