Health, Aging and Later-Life Outcomes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2024-07-22

Brief Summary

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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.

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Detailed Description

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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

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Staff who will assess outcomes at follow up visits will be blinded to group assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

In-Person Caloric Restriction

Intervention Type BEHAVIORAL

20% CR delivered in-person by dietitian/coach

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.

Group Type EXPERIMENTAL

Remote Caloric Restriction

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Time-restricted

Intervention Type 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.

Interventions

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In-Person Caloric Restriction

20% CR delivered in-person by dietitian/coach

Intervention Type BEHAVIORAL

Remote Caloric Restriction

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No