Lifestyle Intervention for Type 2 Diabetes

(RESILIENT Trial)

YD
Overseen ByYan Du, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how lifestyle changes can help older adults with Type 2 Diabetes improve their physical health and overall quality of life. Participants will learn and practice healthy habits, such as better nutrition and exercise, based on the successful Adapted Look Ahead Lifestyle Intervention program. The trial seeks individuals aged 60 and over with Type 2 Diabetes who live near or are members of a specific senior center and can speak English or Spanish. Participants must be willing to follow the study procedures and not have other severe health issues that might prevent safe participation. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance diabetes management for older adults.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this lifestyle intervention is safe for older adults with Type 2 Diabetes?

Research has shown that the lifestyle changes used in this trial, based on the Look AHEAD study, are generally well-received by participants. The Look AHEAD study found that these changes can lead to significant weight loss and better management of health risks for people with Type 2 Diabetes. Over several years, participants reported no major safety issues. This suggests that the lifestyle changes, which focus on improving diet and physical activity, are safe. These findings indicate that the treatment is likely safe for those considering joining this trial.12345

Why are researchers excited about this trial?

Researchers are excited about the Adapted Look Ahead Lifestyle Intervention for Type 2 Diabetes because it emphasizes a holistic approach to managing the condition. Unlike standard treatments that often focus primarily on medication to control blood sugar levels, this intervention integrates improvements in physical activity, diet, and social support to enhance overall health and quality of life. By targeting multiple aspects of health behavior and lifestyle, it has the potential to improve not just blood sugar control, but also physical function, diabetes knowledge, and self-efficacy, offering a comprehensive strategy for managing diabetes.

What evidence suggests that this lifestyle intervention is effective for Type 2 Diabetes?

Research has shown that the Look AHEAD lifestyle program benefits people with Type 2 Diabetes. In earlier studies, participants aimed to lose at least 7% of their starting weight and exercise for 175 minutes each week. These studies demonstrated better physical fitness and improved diabetes control, such as lower blood sugar levels. The program also reduced the risk of heart attacks, strokes, and other heart problems. Overall, this approach has improved quality of life and physical ability for those with Type 2 Diabetes. Participants in this trial will receive an adapted version of the Look AHEAD lifestyle intervention to assess improvements in physical function and other health-related measures.12367

Who Is on the Research Team?

YD

Yan Du, PhD, MPH

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for diverse older adults with Type 2 Diabetes who are interested in improving their physical function and quality of life. Specific eligibility criteria details were not provided, so it's best to contact the study organizers for more information.

Inclusion Criteria

I am 60 years old or older.
I have been diagnosed with type 2 diabetes, confirmed by a health report.
Live within the census tract of the selected senior center, or a member of the senior center
See 3 more

Exclusion Criteria

Enrollment in other diabetes management programs
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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention

Work with community stakeholders to adapt evidence-based lifestyle interventions and develop implementation strategies

Not specified

Intervention

Conduct a senior-center-based 6-month pre- and post-pilot study to assess improvements in physical function and other health-related measures

6 months
Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Adapted Look Ahead Lifestyle Intervention
Trial Overview The trial is testing a multilevel lifestyle intervention adapted from proven methods. It aims to see if this approach, when implemented in senior centers, can help improve physical activity and overall well-being in older adults with Type 2 Diabetes.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Lifestyle intervention groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Clinicians recognize the importance of prediabetes screening and diagnosis, with 93.7% acknowledging it as a significant health issue, yet only 45.2% are familiar with the National Diabetes Prevention Program (DPP).
Despite high screening rates (75.9%) for diabetes among eligible patients, only 50.7% of those diagnosed with prediabetes had their condition documented, and no patients were referred to a DPP, indicating a gap in the implementation of lifestyle change programs.
Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice.Keck, JW., Thomas, AR., Hieronymus, L., et al.[2020]
There is no international consensus on how to classify individuals at high risk for Type 2 diabetes, leading to ongoing debates about the best laboratory tests and thresholds for diagnosis.
Countries are increasingly focusing on preventing Type 2 diabetes through large-scale lifestyle interventions that empower high-risk individuals to make beneficial changes, alongside broader public health strategies to address obesity.
How do we identify people at high risk of Type 2 diabetes and help prevent the condition from developing?Fagg, J., Valabhji, J.[2021]
In the REAL HEALTH-Diabetes study involving 211 participants with type 2 diabetes, both lifestyle intervention (LI) groups (in-person and telephone) achieved similar weight loss outcomes compared to medical nutrition therapy (MNT) at 24 and 36 months, with no statistically significant differences in weight or HbA1c levels.
Despite similar weight loss results, participants in the LI groups reported better dietary skills, suggesting that lifestyle interventions may enhance patient education and self-management in diabetes care.
Results of a 2-year lifestyle intervention for type 2 diabetes: the Reach Ahead for Lifestyle and Health-Diabetes randomized controlled trial.Wexler, DJ., Chang, Y., Levy, DE., et al.[2022]

Citations

The Look AHEAD Study: A Description of the Lifestyle ...The two principal goals of the intervention are to achieve a mean loss ≥ 7% of initial weight and to increase participants' physical activity to ≥ 175 minutes a ...
a secondary analysis of the Look AHEAD clinical trialLook AHEAD was a multicenter, randomized clinical trial of an intensive lifestyle intervention (ILI) designed to reduce caloric intake, increase ...
The Look AHEAD Trial: Implications for Lifestyle Intervention ...Effect of a lifestyle intervention on change in cardiorespiratory fitness in adults with type 2 diabetes: results from the Look AHEAD Study. Internat J Obes ...
Implications of the Diabetes Prevention Program and Look ...The currently available data allow comparison of weight-loss results at 1 year for DPP and Look AHEAD. Translating Evidence-Based Lifestyle Interventions into ...
NCT00017953 | Look AHEAD: Action for Health in DiabetesThe study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are ...
The Lifestyle Intervention for the Treatment of Diabetes ...Although the Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients who received an intensive lifestyle ...
Lifestyle Intervention for Type 2 Diabetes (RESILIENT Trial)Additionally, the Look AHEAD study demonstrated that this treatment led to significant weight loss and improved health outcomes over several years. These ...
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