NCT05424042

Health, Aging and Later-Life Outcomes

Health, Aging and Later-Life Outcomes Pilot Trial (HALLO-P): A 9-month Randomized Pilot Trial of 3 Nutritional Interventions in 120 Older Adults With an Indication for Weight Loss

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot research is to test the feasibility of two interventions focused on either reducing total calorie intake or reducing the total time that calories are ingested each day in older adults. Participation in this research will involve visits to our clinic for testing and weekly intervention visits (in-person or remote depending on group assignment) for nine months with total participation lasting about a year.

Detailed description

This pilot study is part of a larger planning process to design a full-scale randomized trial to evaluate the long-term effects of caloric restriction (CR) and time restricted eating (TRE) on the health of older adults. The specific objective of the HALLO-P is to collect data to inform the design of the full-scale randomized trial to evaluate the long-term effects of caloric restriction and time restricted eating in older adults. The pilot is a 9-month clinical trial. The pilot data will be used to refine recruitment criteria, estimate recruitment yields, and refine intervention approaches.

Conditions

• Aging

Interventions

Type	Name	Description
BEHAVIORAL	In-Person Caloric Restriction	20% CR delivered in-person by dietitian/coach
BEHAVIORAL	Remote Caloric Restriction	20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.
BEHAVIORAL	Time-restricted	8-hour TRE with ad libitum caloric intake. This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake.

Timeline

• Start date: 2022-07-05
• Primary completion: 2024-07-22
• Completion: 2024-07-22
• First posted: 2022-06-21
• Last updated: 2025-10-27
• Results posted: 2025-10-27

Locations

1 site across 1 country: United States