Lifestyle Changes for Healthy Aging

Overseen By Annie Kuan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Neurological disease, Cognitive impairment, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a combination of exercise, mindfulness, and nutrition, collectively known as the Impact 360 program, can improve key health indicators. All participants will eventually receive this 6-month program, though some will start after a short wait. It is ideal for individuals aged 50 to 75 without brain disorders who can use a smartphone to track their progress. Those not currently engaged in intense exercise or specialized mindfulness programs, and without major health conditions affecting movement, may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore holistic health improvements through innovative lifestyle changes.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this intervention is safe for healthy aging?

Research has shown that combining exercise, mindfulness, and nutrition is generally safe for people. In a study on Parkinson's disease, researchers tested a similar program, and participants handled it well, with no serious side effects reported.

Mindfulness and physical activity together can improve mental health, as other studies have shown. These activities are usually safe and can enhance well-being more than doing just one of them. The aim is to help people feel better without causing harm.

This program focuses on making healthy lifestyle changes, which are typically safe for most people. Since this study does not test a drug, it centers on safe, everyday activities like exercise and diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of lifestyle changes, like exercise, diet, and mindfulness, to promote healthy aging. Unlike conventional methods that might focus solely on medication or isolated interventions, this trial uses a comprehensive approach that combines physical activity, nutritional guidance, and stress reduction techniques. By integrating wearable technology to monitor progress and adherence, it offers a more personalized and dynamic way to assess and enhance overall well-being. This holistic method could provide insights into how these combined lifestyle adjustments can delay aging-related issues and improve quality of life.

What evidence suggests that this trial's treatments could be effective for healthy aging?

Studies have shown that healthy lifestyle choices, such as exercising, practicing mindfulness, and eating well, can greatly improve health. Research suggests these habits can influence up to 70% of how bodies age, potentially slowing the aging process. Previous findings indicate that adopting more healthy habits leads to greater benefits. In this trial, the Impact 360 treatment combines these elements to potentially enhance overall health and well-being for participants in the Exercise, Diet, Mindfulness group. ^{3 6 7 8 9}

Who Is on the Research Team?

Silke Appel-Cresswell, MD, FRCPC

Principal Investigator

University of British Colombia

Are You a Good Fit for This Trial?

The Impact 360 study is for individuals aged between 50 to 75 who are generally healthy and do not have any brain disorders. Participants will be involved in activities aimed at promoting healthy aging.

Inclusion Criteria

Participants who are able to complete questionnaires and follow directions for interventions

Have access to a smartphone that can support the Fitbit app

Exclusion Criteria

Any chronic medical condition which would affect ability to participate in exercise

Any contraindication for exercise based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and medical clearance form

I exercise over 180 minutes weekly and practice mindfulness or follow the MIND diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist

Participants in the waitlist group undergo a baseline assessment and continue daily activities for 6 months with monitoring

6 months

Monthly virtual check-ins

Intervention

Participants receive a 6-month multimodal intervention including exercise, mindfulness, and nutrition

6 months

Regular assessments pre- and post-intervention

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Impact 360

Trial Overview This trial tests the combined effect of a regimen including exercise, diet changes, and meditation on health indicators in older adults. It uses a partial crossover design where all participants eventually receive the intervention after initial or delayed phases.

How Is the Trial Designed?

Group I: Exercise, Diet, Mindfulness Experimental Treatment 3 Interventions

The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period.

Group II: Waitlist Group Active Control 1 Intervention

Participants randomized into the waitlist group will undergo a baseline assessment, and will then be encouraged to continue their daily activities as usual for 6 months. Physical activity and sleep will be monitored during this time using wearable devices. Links to questionnaires will be emailed monthly. After the 6-month waitlist period, participants will undergo a second assessment prior to starting the intervention. The multimodal intervention will be 6-months in length, using the same measures of adherence, and will be followed by a final assessment.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

The Jack and Darlene Poole Foundation

Collaborator

Trials

1

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06516146

Study Details | NCT06516146 | Impact 360 for Healthy Agers The Impact 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the ...

2. withpower.com withpower.com/trial/phase-healthy-aging-2024-9e1fc

Lifestyle Changes for Healthy Aging The Impact 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the ...

3. ctv.veeva.com ctv.veeva.com/study/impact-360-for-healthy-agers

Impact 360 for Healthy Agers - ClinicalTrials.Veeva The Impact 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of ...

4. academic.oup.com academic.oup.com/aje/advance-article/doi/10.1093/aje/kwaf138/8183352

Lifestyles modify the biological aging process - Oxford Academic We found that 70.0% of biological age change was attributed to healthy lifestyle factors, and as the number of healthy lifestyle factors increases, the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352648324000552

The impact of an AI-driven personal health platform on ... The evidence for the efficacy of mobile or computer app technology to assist in improving lifestyle and health (including mental health) shows mixed results.

6. mdsabstracts.org mdsabstracts.org/abstract/impact-360-study-for-parkinsons-disease-a-controlled-phase-ii-feasibility-and-safety-study-of-a-combined-exercise-diet-and-mindfulness-intervention/

Impact 360 Study for Parkinson's Disease – a controlled ... Impact 360 Study for Parkinson's Disease – a controlled phase II feasibility and safety study of a combined exercise, diet and mindfulness intervention.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10559194/

Technology-Enabled Intervention to Enhance Mindfulness, ... Primary outcome behaviors promoted by the program are being mindful, healthier eating, more physical activity, and greater restorative sleep.

8. sciencedirect.com sciencedirect.com/science/article/pii/S175529662300073X

Effects of combining physical activity with mindfulness on ... Interventions combining physical activity with mindfulness are effective for improving mental health and wellbeing, possibly more so than either approach alone.

9. portalwiedzy.cm-uj.krakow.pl portalwiedzy.cm-uj.krakow.pl/docstore/download.seam?entityType=article&entityId=UJCMc5591c290c5c4020953af62bc5ea5065&fileId=UJCM128ebb8e64eb4e1da7448729a3552337

The role of mindfulness training supported by virtual reality in the ... Effects of Mindfulness-Based interventions on biomarkers and Low-Grade inflammation in patients with psychiatric disorders: A Meta-Analytic review. Int J ...