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

Wake Forest University (WFU)

Status: Completed

Conditions: Aging

Treatments: Behavioral: In-Person Caloric Restriction; Behavioral: Remote Caloric Restriction; Behavioral: Time-restricted

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05424042

U01AG073240 (U.S. NIH Grant/Contract)

IRB00072563

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

In-Person Caloric Restriction Arm

Experimental group

Description:

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.

Treatment:

Behavioral: In-Person Caloric Restriction

Remote Caloric Restriction Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Remote Caloric Restriction

Time-Restricted Eating Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Time-restricted