Health, Aging and Later-Life Outcomes

NCT05424042 | Completed Results DMC

• 2 other identifiers: IRB00072563U01AG073240
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Keywords

older adults; caloric restriction; time restricted eating

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• Body Weight Change

  From Baseline to Month 6, and From Baseline to 9 Months

• Changes in Fat Mass

  From Baseline to Month 9

• Changes in Lean Body Mass

  From Baseline to Month 9

• Change in Bone Mineral Density

  From Baseline to Month 9

• Change in Resting Energy Expenditure

  From Baseline to Month 9

Study Arms (3)

In-Person Caloric Restriction Arm

EXPERIMENTAL

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

Remote Caloric Restriction Arm

EXPERIMENTAL

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

Time-Restricted Eating Arm

EXPERIMENTAL

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

Interventions

In-Person Caloric Restriction BEHAVIORAL

20% CR delivered in-person by dietitian/coach

In-Person Caloric Restriction Arm

Remote Caloric Restriction BEHAVIORAL

20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.

Remote Caloric Restriction Arm

Time-restricted BEHAVIORAL

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.

Time-Restricted Eating Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 40834924 DERIVED

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Results Point of Contact

• Title: Cynthia Stowe
• Organization: Wake Forest University School of Medicine

cynthia.stowe@advocatehealth.org

336-716-0686

Study Officials

• Stephen B. Kritchevsky, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Barbara J. Nicklas, 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff who will assess outcomes at follow up visits will be blinded to group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One-hundred participants (100) will be randomized to the three study arms in a 1:1:1 ratio. Recruitment will be stratified by sex. Once eligibility is established and baseline testing is completed, participants will be randomized using a permuted block scheme with blocks of varying size stratified by sex to one of the 3 intervention groups.

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: July 5, 2022
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)