Health, Aging and Later-Life Outcomes

Wake Forest University Health Sciences90 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Aging

Interventions

In-Person Caloric RestrictionBEHAVIORAL

20% CR delivered in-person by dietitian/coach

Remote Caloric RestrictionBEHAVIORAL

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

Time-restrictedBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Atrium Health Wake Forest Baptist Hospital

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Number of Participants That Sustained >10% Caloric Restriction

Ability of participants to sustain Caloric Restriction \>10%

Time frame: 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.

Time frame: Month 9

Number of Participants Who Were Retained

Retention \> 85%

Time frame: Month 9

Secondary Outcomes

Body Weight Change

Assessed using home scales.

Time frame: From Baseline to Month 6, and From Baseline to 9 Months

Changes in Fat Mass

Assessed by (Dual-Energy X-Ray Absorptiometry) DXA.