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

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to identify and characterize frailty and pre-frailty in persons age 50 and older living with human immunodeficiency virus (HIV) followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinics (IDSC).

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 data supports the effectiveness of the treatment for Lifestyle Interventions for Aging with HIV/AIDS?

Research shows that personalized nutrition and lifestyle programs can improve health outcomes for people living with HIV/AIDS. For example, nutrition counseling has been shown to help maintain body weight and manage health complications, while a nutrition education program improved dietary habits and cholesterol levels in HIV-positive adults. ^{1 2 3 4 5}

Is the lifestyle intervention for aging with HIV/AIDS safe for humans?

Research on personalized nutrition and lifestyle programs, including those for HIV-positive individuals, suggests they are generally safe and can improve dietary habits and health outcomes. These programs have been shown to help with weight management and improve health markers without significant safety concerns. ^{1 6 7 8 9}

How does the Lifestyle Interventions treatment for Aging with HIV/AIDS differ from other treatments?

This treatment is unique because it focuses on personalized lifestyle changes, such as diet and exercise, tailored to individual needs, rather than relying on medication alone. It aims to improve overall well-being and health outcomes by addressing lifestyle factors, which is different from standard treatments that primarily focus on managing the disease with drugs. ^{6 10 11 12 13}

Research Team

Caryn G Morse, MD, MPH

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

I am 50 years old or older.

Person living with human immunodeficiency virus (HIV)

Eligible for Ryan White Program

Exclusion Criteria

I am younger than 50 years old.

Unable to complete the required assessments or questionnaires

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Nutritional Issues and Positive Living in Human Immunodeficiency Virus/AIDS. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Which screening method is appropriate for older cancer patients at risk for malnutrition? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Effects of a Nutrition Education Program on Dietary Intake and Biomarkers in HIV+ Adults. [2022]

6. Switzerland 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A tool for individualized management of fat-controlled diets. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association: individualized nutrition approaches for older adults in health care communities. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Beneficial effect of personalized lifestyle advice compared to generic advice on wellbeing among Dutch seniors - An explorative study. [2020]

12. United States 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. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Nutrition and health promotion in older adults. [2019]