Lifestyle Interventions for Aging with HIV/AIDS

Overseen By Caryn G Morse, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 50, unable to complete assessments

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping people aged 50 and older living with HIV to identify and manage frailty, a state of reduced strength and energy. Participants will receive a customized plan with exercise and nutrition suggestions to improve health and daily life. Those living with HIV, over 50, and experiencing weakness or reduced activity may find this trial beneficial. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance the quality of life for others facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these lifestyle interventions are safe for aging individuals with HIV/AIDS?

Research shows that physical activity is safe and beneficial for people living with HIV. Studies have found that exercise can improve fitness, lift mood, and enhance overall quality of life. For those over 50, staying active can also aid in walking and reduce frailty.

Regarding nutrition, a personalized approach appears promising. Research indicates that customized nutrition plans can improve lifestyle habits and support better health. People living with HIV have special nutritional needs due to the virus's impact on the body, and tailoring nutrition to meet these needs can be advantageous.

Overall, both exercise and nutrition plans are well-tolerated and offer health benefits. Studies have not reported any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these lifestyle interventions for aging with HIV/AIDS because they offer a personalized approach unlike existing standard treatments, which often focus on medication alone. The customized activity plan is designed to enhance physical fitness through tailored exercises and community activities, which can improve overall well-being and quality of life. Similarly, the personalized nutrition plan addresses individual dietary needs, potentially improving health outcomes by targeting specific nutritional deficits. These interventions aim to empower individuals with HIV/AIDS to actively manage their health in a holistic manner, something traditional treatments may not focus on as directly.

What evidence suggests that this trial's treatments could be effective for aging with HIV/AIDS?

This trial compares two lifestyle interventions for aging individuals with HIV/AIDS. Participants in the "Activity Intervention" arm receive a customized activity plan. Research has shown that such plans can improve health by enhancing heart and lung function, making walking easier, and increasing CD4 counts to support the immune system. Meanwhile, participants in the "Nutrition Intervention" arm receive a personalized nutrition plan tailored to the specific nutritional needs caused by the virus's effects on the body. Good nutrition can improve health and support the immune system, making these approaches promising for older adults with HIV. ^{1 2 3 6 7}

Who Is on the Research Team?

Caryn G Morse, MD, MPH

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for people aged 50 or older who are living with HIV and are followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinic. Participants should be eligible for the Ryan White Program, able to give informed consent, and identified as pre-frail or frail according to an electronic frailty index.

Inclusion Criteria

Person living with human immunodeficiency virus (HIV)

Eligible for Ryan White Program

I am 50 years old or older.

Exclusion Criteria

Unable to complete the required assessments or questionnaires

I am younger than 50 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Frailty Assessment

Electronic medical record-based screening for frailty and comprehensive geriatric screening

12 weeks

Multiple visits for assessments

Intervention

Customized activity and nutrition plan offered to a subset of participants

12 weeks

Regular follow-ups to monitor adherence and effectiveness

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Customized activity plan
• Customized nutrition plan

Trial Overview

The study aims to understand challenges in healthy aging among older adults with HIV. It involves creating customized activity and nutrition plans tailored to each participant's needs to address issues related to frailty.

How Is the Trial Designed?

Group I: Nutrition Intervention Experimental Treatment 1 Intervention

Development of a customized nutrition plan to address nutritional needs.

Group II: Activity Intervention Experimental Treatment 1 Intervention

Customized selection of exercise and other community and online activity options to improve activity.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials

88

Recruited

152,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The American Dietetic Association emphasizes that personalized, less-restrictive diets can significantly improve the quality of life and nutritional status of older adults in healthcare settings.

Involving older adults in dietary decisions can enhance their willingness to eat, thereby reducing the risk of undernutrition and its associated health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association: individualized nutrition approaches for older adults in health care communities. Dorner, B., Friedrich, EK., Posthauer, ME.[2019]

In a nine-week study involving 59 seniors, personalized lifestyle advice led to improvements in resilience and motivation, as well as reductions in body fat percentage and hip circumference, compared to generic advice.

While overall self-perceived health did not change significantly, both personalized and generic advice groups showed improvements in physical functioning, indicating potential benefits of tailored interventions for seniors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effect of personalized lifestyle advice compared to generic advice on wellbeing among Dutch seniors - An explorative study. Doets, EL., de Hoogh, IM., Holthuysen, N., et al.[2020]

Self-management programs (SMPs) can lead to small but significant improvements in physical activity, dietary habits, and health responsibility among individuals with chronic diseases, based on a meta-analysis of 25 studies involving 5,681 participants.

Short-term SMPs (less than 12 weeks) were particularly effective for modifying these health behaviors, especially when delivered by experts and compared to inactive controls, although the programs did not show significant effects on stress management or smoking behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of self-management programs on behavioral modification among individuals with chronic disease: A systematic review and meta-analysis of randomized trials. Kim, S., Park, M., Song, R.[2021]

Health promotion programs for older adults, particularly in nutrition and lifestyle changes, can significantly extend healthy years of life, although their effectiveness may decrease with age.

Implementing nutritional interventions early in life can lead to substantial reductions in healthcare costs by preventing or delaying nutrition-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and health promotion in older adults. Chernoff, R.[2019]

A 10-week personalized systems nutrition (PSN) program involving 82 healthy participants led to significant reductions in calorie intake and various unhealthy dietary components, resulting in decreased body weight, BMI, and body fat.

The program was particularly effective for individuals with lower phenotypic flexibility, showing notable reductions in LDL and total cholesterol levels, suggesting that personalized nutrition can effectively target behavior change in health-compromised groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Personalized Systems Nutrition Program Improves Dietary Patterns, Lifestyle Behaviors and Health-Related Outcomes: Results from the Habit Study. de Hoogh, IM., Winters, BL., Nieman, KM., et al.[2021]

The HIV-Care-Program, which included nutrition and lifestyle counseling over 6 months, significantly reduced the decline in CD4 counts in HIV-infected patients compared to usual care, with a drop of only 46.3 cells in the intervention group versus 129 cells in the control group.

The program also delayed the initiation of antiretroviral therapy (ARV) by about 1 month longer in the intervention group, suggesting it can help manage healthcare resources more effectively while improving patient health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an HIV-Care-Program on immunological parameters in HIV-positive patients in Yaoundé, Cameroon: a cluster-randomized trial. Nkengfack, GN., Torimiro, JN., Ngogang, J., et al.[2021]

Seventeen community-based, home-delivered meal programs have been established in major cities over the past decade to address the specialized nutritional needs of homebound individuals living with HIV/AIDS.

These programs not only provide meals but also include nutrition counseling and regular evaluations, highlighting the importance of clinical dietitians and public health nutritionists in referring clients to these essential services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-delivered meal programs for homebound people with HIV/AIDS. Kraak, VI.[2013]

Malnutrition is a significant risk for older cancer patients, and various validated screening tools can effectively identify those at risk, emphasizing the importance of regular screening at diagnosis and during follow-up.

Nutritional assessments, conducted by dietitians or geriatricians after initial screening, are crucial for developing care plans that improve patient outcomes, highlighting the need for clear communication of these assessments across care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which screening method is appropriate for older cancer patients at risk for malnutrition? Isenring, E., Elia, M.[2022]

A new tool for managing fat-controlled diets allows for personalized dietary recommendations based on individual food preferences, rather than rigidly restricting certain foods.

This approach groups commonly eaten foods by their fat content, enabling patients to adjust their diets while still adhering to fat control guidelines, making it easier to follow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tool for individualized management of fat-controlled diets. Jansen, C., Dupont, J., Blaker, GG.[2006]

Tailored nutrition education has been shown to effectively improve dietary habits in adults over the long term (6 months or more), based on a systematic review of 20 trials with moderate to good quality.

While the results are promising, future research should focus on better reporting and objective measures to ensure the reliability of findings and target outcomes that are most relevant to nutrition-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does tailoring make a difference? A systematic review of the long-term effectiveness of tailored nutrition education for adults. Eyles, HC., Mhurchu, CN.[2022]

The Visiting Nurse Service HIV/Home Delivered Meals Program provided 50 clients with HIV/AIDS energy-enhanced meals and nutrition support over 6 months, leading to improved food consumption and weight management for many participants.

Out of 35 participants assessed, 13 gained weight on average by 6 pounds, and the program helped increase the number of participants considered to be 'doing well' from 14 to 19, demonstrating the effectiveness of dietitian-led medical nutrition therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based, interagency approach by dietitians to provide meals, medical nutrition therapy, and education to clients with HIV/AIDS. Topping, CM., Humm, DC., Fischer, RB., et al.[2006]

Nutritional counseling by registered dietitians/nutritionists significantly improves dietary intake in individuals with HIV/AIDS, helping to address the metabolic issues caused by the infection and treatment.

Effective nutrition management can help maintain lean body weight, reduce oxidative stress, and manage complications like hyperglycemia and hyperlipidemia, highlighting the importance of professional dietary support in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Issues and Positive Living in Human Immunodeficiency Virus/AIDS. Clark, WA., Cress, EM.[2019]

A weekly 1-hour nutrition education program significantly improved dietary behaviors and serum biomarkers in people living with HIV, with better outcomes for those who attended more classes (n=62 participants).

Participants with good attendance showed improvements in cholesterol levels and overall dietary intake, while those who attended fewer or no classes experienced worsening health metrics, highlighting the importance of consistent nutrition education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Nutrition Education Program on Dietary Intake and Biomarkers in HIV+ Adults. Poles, J., Tiozzo, E., Konefal, J., et al.[2022]

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