Health, Aging and Later-Life Outcomes

Study Overview
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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.

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.

Official Title
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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

Conditions
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Aging

Intervention / Treatment
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* Behavioral: In-Person Caloric Restriction
* Behavioral: Remote Caloric Restriction
* Behavioral: Time-restricted


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Person Caloric Restriction Arm<br>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<br>* 20% CR delivered in-person by dietitian/coach<br>|
| Experimental: Remote Caloric Restriction Arm<br>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<br>* 20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.<br>|
| Experimental: Time-Restricted Eating Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of sustained CR | CR > 10% | Month 9 | 
| TRE sustainability | At least 75% of participants eating within window on >80% of days | Month 9 | 
| Retention of study participants | 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 | 
| Changes in Fat | Assessed by (Dual-Energy X-Ray Absorptiometry) DXA. | From Baseline to Month 9 | 
| Changes in Lean Body Mass | Assessed by DXA | From Baseline to Month 9 | 
| Change in Bone Mineral Density | Assessed by DXA | From Baseline to Month 9 | 
| Change in Resting Energy Expenditure | Assessed by Indirect Calorimetry | From Baseline to Month 9 | 
| 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 Total Muscle Mass | Assessed by d3 creatine (d3cr) | 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 Walk Time | 400m walk - assessed in minutes/secs (unlimited time) | From Baseline to Month 9 | 
| Physical Function--Change in Grip Strength | measured in kg (0-90kg) | From Baseline to Month 9 | 
| Physical Function--Change in eSPPB | Change in overall physical performance with total score ranging from 0 to 12 with a higher score denoting better physical function. | 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 | 
| Change in Age-Related Biomarkers--Fasting Insulin |  | From Baseline to 9 Months | 
| Change in Age-Related Biomarkers--interleukin-6 (IL-6) |  | From Baseline to 9 Months | 
| Change in Age-Related Biomarkers--tumor necrosis factor soluble receptor I (TNFRI) |  | From Baseline to 9 Months | 
| Change in Age-Related Biomarkers--cystatin C | and CRP from serum | From Baseline to 9 Months | 
| Change in Age-Related Biomarkers-- CRP from serum |  | From Baseline to 9 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older adults, caloric restriction, time restricted eating