NCT05251402

Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern

The ALOHA Trial: Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the ALOHA trial is to investigate the efficacy of improved diet quality following a DASH behavioral intervention that has shown promising results in adults with uncontrolled asthma. DASH stands for Dietary Approaches to Stop Hypertension. This healthy diet is known to help people with high blood pressure manage their health. But physicians do not know if the DASH diet can also benefit patients with uncontrolled asthma. Researchers in the ALOHA study are trying to find out the answer to this important question. Researchers at UIC are studying how 2 asthma care programs compare in terms of helping adults with uncontrolled asthma to improve their quality of life. Researchers also want to learn what might explain the differences in patient outcomes that they may see between the 2 programs. The primary outcome will be asthma-specific quality of life. If the DASH behavioral intervention is found to benefit people with uncontrolled asthma, it would provide a practical, safe, and acceptable public-health intervention in the form of dietary modification to reduce the burden of asthma.

Detailed description

Approximately 320 subjects who are determined fully eligible will be randomly assigned (by chance, like flipping a coin) to participate in intervention Group A or Group B, where you will receive either 1 of the 2 asthma care programs Both asthma care programs are for a year and offer patient education on asthma and health. In both asthma care programs, you will receive fact-based patient information on asthma and health. Additionally, in one of the programs, a registered dietitian will also provide nutrition counseling on how to follow the USDA recommended DASH diet. Both asthma care programs offer 3 individual sessions, 8 group sessions, and 11 phone consultations. Your first individual session will be in-person with a trained health coach on the ALOHA team. The remaining 2 individual sessions will be either in-person or remote, depending on what you and your coach decide. You will also attend the first 2 (of 8) group sessions in-person to build connection with your coach and peer participants in the group. You and your coach will then decide whether you should attend the remaining group sessions in-person or remotely. Your ALOHA health coach will offer you continued support by phone until you complete your 1-year program. Study Visits at UIC: Irrespective of your asthma care group, all participants will be expected to visit UIC Study site 4 times over the next year, initially and then at 3 months, at 6 months, and finally at one year. You will meet with an ALOHA study coordinator for 2 hours at the initial and final visits and for 1 hour at 3 and 6 months. Before each visit, you will complete online surveys about your health and phone interviews about your diet. At each visit, you will complete a breathing test, a blood draw, a physical exam, and questions about your asthma, diet and exercise habits, use of asthma medications and dietary supplements.

Conditions

• Asthma

Interventions

Type	Name	Description
BEHAVIORAL	Group A - Patient Education	If you are assigned to this group, you will receive education on asthma and health from an ALOHA health coach. * In months 1-3, you will attend 3 individual and 8 group sessions. Individual sessions will last \~15 minutes and the first one will be in-person. Group sessions will last \~30 minutes and the first 2 of the 8 will be in person. You and your coach will determine if you may attend the remaining individual and group sessions remotely instead, via Zoom or phone. The purpose of these sessions is to provide you with general information about respiratory health topics, including recommendations for asthma care, inhaler use, and lung health. * In months 4-12, you will complete 11 phone check-ins for \~10 minutes each. The purpose of these phone calls is to provide you with ongoing support and discuss health topics of your choice.
BEHAVIORAL	Group B - Patient Education with Nutrition Counseling	If you are assigned to this group, you will receive the same patient education as Group A. In addition, you will receive nutrition counseling from your health coach who is a registered dietitian. * In months 1-3, the duration of the sessions will increase to \~30 minutes each for the 3 individual sessions and to \~60 minutes each for the 8 group sessions. This is because in addition to providing the same information on asthma and health as in Group A, your health coach will also counsel you on how to follow the DASH diet by adopting effective behavior change techniques such as goal setting, self-monitoring, and problem solving. * In months 4-12, your health coach will review your progress, provide you with personalized feedback, assist you in problem solving as you continue to work towards the DASH dietary goals, and help you maintain the changes you have made over the long term.

Timeline

• Start date: 2022-03-09
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2022-02-22
• Last updated: 2025-06-19

Locations

2 sites across 1 country: United States