20 Participants Needed

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)

Trial Summary

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 data supports the idea that Lifestyle Intervention for Type 2 Diabetes is an effective treatment?

The available research shows that Lifestyle Intervention for Type 2 Diabetes is effective in helping people lose weight and manage their condition. For example, the Reach Ahead for Lifestyle and Health-Diabetes study found that participants in the lifestyle intervention group lost more weight than those who only received medical nutrition therapy. Additionally, the Look AHEAD study demonstrated that this treatment led to significant weight loss and improved health outcomes over several years. These studies suggest that lifestyle changes can be a powerful way to manage Type 2 Diabetes, especially when compared to standard care.12345

What data supports the effectiveness of the treatment Adapted Look Ahead Lifestyle Intervention for Type 2 Diabetes?

Research shows that the Adapted Look Ahead Lifestyle Intervention helps people with type 2 diabetes lose more weight compared to standard nutrition advice. This weight loss can lead to better management of diabetes and overall health improvements.12345

What safety data exists for the lifestyle intervention for Type 2 diabetes?

The Look AHEAD intensive lifestyle intervention, which serves as an exemplar for lifestyle interventions in Type 2 diabetes, has been extensively studied. It has demonstrated broad and clinically meaningful health improvements, particularly in weight management and cardiovascular risk reduction. The intervention has been evaluated in both efficacy and effectiveness trials, indicating its safety and effectiveness in real-world settings. The research highlights the importance of behavior change expertise in developing and delivering these interventions, ensuring their safe adaptation and dissemination.56789

Is the Look AHEAD Lifestyle Intervention safe for humans?

The Look AHEAD Lifestyle Intervention, which focuses on weight loss and behavior changes for people with Type 2 diabetes, has been shown to be safe and effective in improving health outcomes like weight management and fitness. It has been used successfully in various studies without major safety concerns.56789

Is the Adapted Look Ahead Lifestyle Intervention a promising treatment for Type 2 Diabetes?

Yes, the Adapted Look Ahead Lifestyle Intervention is a promising treatment for Type 2 Diabetes. It helps people lose weight, which is important because most people with Type 2 Diabetes are overweight. Losing weight can improve heart health and make managing diabetes easier. Studies show that this lifestyle change can lead to long-term success in managing weight and improving overall health.3581011

How is the Adapted Look Ahead Lifestyle Intervention treatment different from other treatments for type 2 diabetes?

The Adapted Look Ahead Lifestyle Intervention is unique because it focuses on intensive lifestyle changes, such as weight loss and increased physical activity, rather than relying solely on medication. This approach has shown greater weight loss and improved health outcomes compared to standard medical nutrition therapy.3581011

What is the purpose of this trial?

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).

Research Team

YD

Yan Du, PhD, MPH

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Lifestyle intervention groupExperimental Treatment1 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).

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+

Findings from Research

In a study involving 2329 participants across 209 treatment groups, weight loss outcomes did not cluster within groups, indicating that individual weight loss was largely independent of group dynamics.
While adherence to the weight loss program showed some clustering among group members, factors like group size and member homogeneity did not significantly impact overall weight loss outcomes, suggesting that simply being in a group may not enhance weight loss effectiveness.
Do weight loss and adherence cluster within behavioral treatment groups?Wing, RR., Leahey, T., Jeffery, R., et al.[2021]
In the Look AHEAD study involving 5,145 overweight or obese adults with type 2 diabetes, those who participated in the intensive lifestyle intervention (ILI) lost an average of 4.7% of their initial weight over 8 years, significantly more than the 2.1% weight loss in the usual care group (P < 0.001).
The ILI not only led to greater weight loss but also encouraged healthier weight-control behaviors, with 50.3% of ILI participants achieving at least a 5% weight loss compared to 35.7% in the usual care group, indicating its effectiveness in managing obesity-related conditions.
Eight-year weight losses with an intensive lifestyle intervention: the look AHEAD study.[2022]
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]

References

Do weight loss and adherence cluster within behavioral treatment groups? [2021]
Eight-year weight losses with an intensive lifestyle intervention: the look AHEAD study. [2022]
Results of a 2-year lifestyle intervention for type 2 diabetes: the Reach Ahead for Lifestyle and Health-Diabetes randomized controlled trial. [2022]
The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it. [2022]
Evidence-based lifestyle interventions for obesity and Type 2 diabetes: The Look AHEAD intensive lifestyle intervention as exemplar. [2022]
How do we identify people at high risk of Type 2 diabetes and help prevent the condition from developing? [2021]
Effect of a lifestyle intervention on change in cardiorespiratory fitness in adults with type 2 diabetes: results from the Look AHEAD Study. [2021]
Four-year change in cardiorespiratory fitness and influence on glycemic control in adults with type 2 diabetes in a randomized trial: the Look AHEAD Trial. [2022]
Weight loss through living well: translating an effective lifestyle intervention into clinical practice. [2022]
The development and description of the comparison group in the Look AHEAD trial. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice. [2020]
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