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The Health, Aging, and Later-Life Outcomes Pilot Study: Design, recruitment, and participants’ baseline characteristics

Cynthia L. Stowe,Kimberly Kennedy,Shannon S. Emilson,R. Neiberg,S. Kritchevsky,Michael E. Miller,Denise K. Houston,Barbara J. Nicklas,Jason Fanning,W. Rejeski

Published 2025 in Contemporary Clinical Trials

ABSTRACT

Background: Multi-morbidity increases significantly with age, and obesity is a major risk factor for conditions like cardiovascular disease and diabetes, indicating a critical need for effective interventions. Objective: We discuss the study design of the HALLO-Pilot Study that randomized older adults to in-person caloric restriction (CR), remotely delivered CR (RCR), or a time restricted eating (TRE) intervention. In addition, we emphasize inclusion/exclusion criteria, recruitment, and baseline characteristics of randomized participants. Methods: The study randomized 90 participants aged 60+ to one of three 9-month interventions. Eligibility focused on including adults with an indication for weight loss while excluding for safety concerns or factors potentially affecting adherence. Screening involved telephone interviews and in-person visits. Assessments included measures for eligibility, outcomes, adherence, and safety, with data collected at baseline, 6 months, and 9 months. The intervention involved in-person or online group meetings and individual contacts with participants monthly. Interventions included nutritional and behavioral guidance and a targeted increase in steps per day. Remote monitoring technology was used for monitoring diet and weight for CR participants and logging eating times for TRE participants. Results: There were a total of 1753 pre-screening contacts with 678 (39 %) completing telephone screening. Of 139 (~21 %) who were eligible after the telephone screening and consented, 135 participants attended in-person screening visits. Of those screened in-person, 90 were eligible and randomized for a yield of 13 %. Conclusion: The HALLO-Pilot Study provided valuable insights into eligibility criteria and the recruitment of older adults for future large-scale trials of CR and TRE. Clinical Trials.gov: NCT05424042.

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