Health, Aging and Later-Life Outcomes (HALLO-P)

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: In-Person Caloric Restriction; Behavioral: Remote Caloric Restriction; Behavioral: Time-restricted

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Community-dwelling men and women residing in Forsyth County, NC or surrounding counties
• obesity (BMI = 30 - < =40 kg/m2) or are overweight (BMI = 27 - <30 kg/m2 with an indication for weight loss (e.g., hypertension, hyperlipidemia, elevated waist girth, controlled diabetes)

Exclusion Criteria:

• persons for whom the interventions are potentially unsafe
• history of eating or nutritional disorders
• those who are likely to drop out due to severe chronic illness or other reasons
• who show inability to perform self-monitoring activities required by the interventions
• those doing shift work because disturbances in circadian cycles may interfere with TRE
• uncontrolled or previously undetected diabetes because disease management may interfere with the interventions
• certain medical treatments may complicate outcome interpretation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-Person Caloric Restriction Arm; This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Behavioral: In-Person Caloric Restriction; 20% CR delivered in-person by dietitian/coach
Experimental: Remote Caloric Restriction Arm; This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Behavioral: Remote Caloric Restriction; 20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.
Experimental: Time-Restricted Eating Arm; 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. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Sustained >10% Caloric Restriction	Ability of participants to sustain Caloric Restriction >10%	Month 9
Ability to Maintain Time Restricted Eating (TRE) Intervention	This will measure the sustainability in a 9 month period of time and will be reported as the percentage of day eating within <= 8.5 hour window which is pre-specified for each participant.	Month 9
Number of Participants Who Were Retained	Retention > 85%	Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight Change	Assessed using home scales.	From Baseline to Month 6, and From Baseline to 9 Months
Change in Physical Activity Energy Expenditure	Assessed by ActivPAL	From Baseline to Month 9
Change in Energy Intake	Using doubly-labeled water (DLW). Energy intake will be calculated from Total Energy Expenditure (TEE) assessed by DLW and change in body energy stores (measured by body weight and/or DXA) according to the equation: Energy Intake = TEE + Change in body energy stores	From Baseline to Month 9
Change in Self-Reported Energy Intake	Data will be collected and nutrients and food groups analyzed using the publicly available National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment tool.	From Baseline to Month 9
Physical Function--Change in Grip Strength	measured in kg (0-90kg)	From Baseline to Month 9
Change in Cognitive Function--MoCA	Total score ranges from 0-30 with a higher score denoting better cognitive function.	From baseline to Month 9
Changes in Fat Mass	Assessed by (Dual-Energy X-Ray Absorptiometry) DXA.	From Baseline to Month 9
Changes in Lean Body Mass	As assessed by DXA for the total lean body mass.	From Baseline to Month 9
Change in Bone Mineral Density	As assessed by DXA using the Hip BMD	From Baseline to Month 9
Change in Resting Energy Expenditure	As assessed by Indirect Calorimetry between baseline and 9 months follow-up	From Baseline to Month 9
Change in Total Muscle Mass	The D3-Creatine (D3Cr) method used to assess total muscle mass is completed after the participant ingests a known amount of D3-creatine (creatine with deuterium atoms replacing hydrogens) and the labeled creatine is distributed throughout the body, with approximately 98% ending up in skeletal muscle. By measuring the ratio of labeled (D3-creatinine) to unlabeled creatinine in a urine sample the total body creatine pool can be determined and total muscle mass can be calculated.	From Baseline to Month 9
Physical Function--Change in Walk Time	400m walk - assessed in number of seconds (unlimited time)	From Baseline to Month 9
Physical Function--Change in eSPPB	Change in overall physical performance with total score ranging from 0 to 4 with a higher score denoting better physical function.	From Baseline to Month 9
Change in Age-Related Biomarkers--Fasting Insulin	Fasting insulin, an age-related biomarker	From Baseline to 9 Months
Change in Age-Related Biomarkers--interleukin-6 (IL-6)	Interleukin-6 (IL-6) is an Age-related biomarker, cytokine, and key mediator of inflammation	From Baseline to 9 Months
Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI)	Tumor Necrosis Factor Receptor 1 (TNRFI), an Age-Related Biomarker, is a protein that acts as a receptor for TNF-alpha, a cytokin involved in inflammation.	From Baseline to 9 Months
Change in Age-Related Biomarkers--cystatin C	Change in cystatin C - An Age-Related Biomarker used to assess kidney function	From Baseline to 9 Months
Change in Age-Related Biomarkers-- CRP From Serum	Change in C-reactive Protein, an Age-Related Biomarker that is used to detect inflammation in the body	From Baseline to 9 Months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Barbara J. Nicklas, PhD, Wake Forest University Health Sciences; Principal Investigator: Stephen B. Kritchevsky, PhD, Wake Forest University Health Sciences; Principal Investigator: Michael E. Miller, PhD, Wake Forest University Health Sciences; Principal Investigator: W. Jack Rejeski, PhD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Stowe CL, Kennedy K, Emilson SS, Neiberg RH, Kritchevsky SB, Miller ME, Houston DK, Nicklas BJ, Fanning J, Rejeski WJ; HALLO-P Investigators. The Health, Aging, and Later-Life Outcomes Pilot Study: Design, recruitment, and participants' baseline characteristics. Contemp Clin Trials. 2025 Oct;157:108049. doi: 10.1016/j.cct.2025.108049. Epub 2025 Aug 18.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): July 22, 2024
• Study Completion (Actual): July 22, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: older adults; time restricted eating; caloric restriction
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Fasting; Intermittent Fasting
• Other Study ID Numbers: IRB00072563; U01AG073240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No