Lifestyle Intervention for Type 2 Diabetes

(RESILIENT Trial)

Overseen By Yan Du, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Severe heart disease, end-stage renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

Who Is on the Research Team?

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

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?

Group I: Lifestyle intervention group Experimental Treatment 1 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).

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Look AHEAD study, involving 5145 participants with type 2 diabetes, aims to determine if intentional weight loss can reduce cardiovascular risks, focusing on a goal of losing at least 7% of initial weight and increasing physical activity to 175 minutes per week.

The lifestyle intervention includes structured meal replacements and ongoing support from a multidisciplinary team, ensuring safety by monitoring participants for potential hypoglycemic episodes during the weight loss process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it. Wadden, TA., West, DS., Delahanty, L., et al.[2022]

The Diabetes Support and Education Intervention was developed as a comparison group for the Look AHEAD trial, which aimed to assess the effectiveness of an Intensive Lifestyle Intervention in reducing cardiovascular risks in overweight individuals with type 2 diabetes.

Participant feedback on the Diabetes Support and Education Intervention was very positive, contributing to excellent retention rates over the first four years, indicating that a well-structured comparison group is crucial for the success of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and description of the comparison group in the Look AHEAD trial. Wesche-Thobaben, JA.[2021]

Behavioral lifestyle interventions for obesity in individuals with Type 2 diabetes have shown significant and lasting health improvements, highlighting their importance in disease management.

The Look AHEAD intensive lifestyle intervention serves as a successful model for secondary prevention of Type 2 diabetes and obesity, emphasizing the need for behavior change expertise in developing effective weight control strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based lifestyle interventions for obesity and Type 2 diabetes: The Look AHEAD intensive lifestyle intervention as exemplar. West, DS., Coulon, SM., Monroe, CM., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight-year weight losses with an intensive lifestyle intervention: the look AHEAD study. [2022]

An intensive lifestyle weight loss intervention (ILI) significantly improved fitness levels in overweight and obese adults with type 2 diabetes, showing a 20.9% increase in fitness compared to just 5.7% in the diabetes support and education (DSE) group after one year.

The ILI also led to a greater increase in physical activity, with participants burning an average of 892 kcal per week compared to 108 kcal per week in the DSE group, indicating that lifestyle changes can enhance both fitness and physical activity, contributing to better metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a lifestyle intervention on change in cardiorespiratory fitness in adults with type 2 diabetes: results from the Look AHEAD Study. Jakicic, JM., Jaramillo, SA., Balasubramanyam, A., et al.[2021]

An intensive lifestyle intervention (ILI) significantly improved fitness levels and physical activity in overweight/obese adults with type 2 diabetes over 4 years, with a fitness change of 3.70% compared to only 0.94% in the diabetes support and education (DSE) group.

Improved fitness was linked to better glycemic control, as indicated by lower HbA1c levels, while changes in physical activity alone did not show a similar relationship, highlighting the importance of fitness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jakicic, JM., Egan, CM., Fabricatore, AN., et al.[2022]

The Diabetes Prevention Program (DPP) lifestyle intervention, implemented in a clinical setting, resulted in an average weight loss of 5.19 kg over one year for participants, demonstrating its effectiveness in managing weight among patients with a BMI over 25.

27% of participants who enrolled in the program achieved a weight loss of 7% or more, compared to only 6% of those who did not enroll, highlighting the program's potential for significant health benefits in a real-world clinical environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss through living well: translating an effective lifestyle intervention into clinical practice. McTigue, KM., Conroy, MB., Bigi, L., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do weight loss and adherence cluster within behavioral treatment groups? Wing, RR., Leahey, T., Jeffery, R., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2613279/

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 ...

2.

drc.bmj.com

drc.bmj.com/content/12/3/e004079

a secondary analysis of the Look AHEAD clinical trial

Look AHEAD was a multicenter, randomized clinical trial of an intensive lifestyle intervention (ILI) designed to reduce caloric intake, increase ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4501472/

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 ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002822308000631

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 ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00017953

NCT00017953 | Look AHEAD: Action for Health in Diabetes

The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714416304645

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 ...

7.

withpower.com

withpower.com/trial/phase-diabetes-mellitus-type-2-1-2024-b4f41

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 ...