Aging
Conditions
Keywords
older adults, caloric restriction, time restricted eating
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.
Detailed 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.
Interventions
BEHAVIORALIn-Person Caloric Restriction
20% CR delivered in-person by dietitian/coach
BEHAVIORALRemote Caloric Restriction
20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.
BEHAVIORALTime-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.
Sponsors
National Institute on Aging (NIA)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Staff who will assess outcomes at follow up visits will be blinded to group assignment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Sustained >10% Caloric Restriction | Month 9 | Ability of participants to sustain Caloric Restriction \>10% |
| Ability to Maintain Time Restricted Eating (TRE) Intervention | Month 9 | 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. |
| Number of Participants Who Were Retained | Month 9 | Retention \> 85% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Mineral Density | From Baseline to Month 9 | As assessed by DXA using the Hip BMD |
| Change in Resting Energy Expenditure | From Baseline to Month 9 | As assessed by Indirect Calorimetry between baseline and 9 months follow-up |
| Change in Physical Activity Energy Expenditure | From Baseline to Month 9 | Assessed by ActivPAL |
| Change in Energy Intake | From Baseline to Month 9 | 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 |
| Change in Total Muscle Mass | From Baseline to Month 9 | The D3-Creatine (D3Cr) method used to assess total muscle mass is completed after the participant ingests a known amount of D3-creatine (creatine with deuterium atoms replacing hydrogens) and the labeled creatine is distributed throughout the body, with approximately 98% ending up in skeletal muscle. By measuring the ratio of labeled (D3-creatinine) to unlabeled creatinine in a urine sample the total body creatine pool can be determined and total muscle mass can be calculated. |
| Change in Self-Reported Energy Intake | From Baseline to Month 9 | 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. |
| Physical Function--Change in Walk Time | From Baseline to Month 9 | 400m walk - assessed in number of seconds (unlimited time) |
| Body Weight Change | From Baseline to Month 6, and From Baseline to 9 Months | Assessed using home scales. |
| Physical Function--Change in eSPPB | From Baseline to Month 9 | Change in overall physical performance with total score ranging from 0 to 4 with a higher score denoting better physical function. |
| Change in Cognitive Function--MoCA | From baseline to Month 9 | Total score ranges from 0-30 with a higher score denoting better cognitive function. |
| Change in Age-Related Biomarkers--Fasting Insulin | From Baseline to 9 Months | Fasting insulin, an age-related biomarker |
| Change in Age-Related Biomarkers--interleukin-6 (IL-6) | From Baseline to 9 Months | Interleukin-6 (IL-6) is an Age-related biomarker, cytokine, and key mediator of inflammation |
| Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI) | From Baseline to 9 Months | Tumor Necrosis Factor Receptor 1 (TNRFI), an Age-Related Biomarker, is a protein that acts as a receptor for TNF-alpha, a cytokin involved in inflammation. |
| Change in Age-Related Biomarkers--cystatin C | From Baseline to 9 Months | Change in cystatin C - An Age-Related Biomarker used to assess kidney function |
| Change in Age-Related Biomarkers-- CRP From Serum | From Baseline to 9 Months | Change in C-reactive Protein, an Age-Related Biomarker that is used to detect inflammation in the body |
| Physical Function--Change in Grip Strength | From Baseline to Month 9 | measured in kg (0-90kg) |
| Changes in Fat Mass | From Baseline to Month 9 | Assessed by (Dual-Energy X-Ray Absorptiometry) DXA. |
| Changes in Lean Body Mass | From Baseline to Month 9 | As assessed by DXA for the total lean body mass. |
Countries
United States
Participant flow
Recruitment details
Recruitment began in July 2022 at one clinical site.
Pre-assignment details
Participants were pre-screened on the phone and then brought in for consent then two screening visits which included a run in period prior to randomization to groups.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 34 |
| 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. | 34 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 4 |
Baseline characteristics
| Characteristic | In-Person Caloric Restriction Arm | Total | Time-Restricted Eating Arm | Remote Caloric Restriction Arm |
|---|---|---|---|---|
| 400 meter Fast Walk Time | 292.4 seconds STANDARD_DEVIATION 42.4 | 299.8 seconds STANDARD_DEVIATION 40 | 398.7 seconds STANDARD_DEVIATION 36.4 | 305.2 seconds STANDARD_DEVIATION 42.2 |
| Age, Continuous | 66.6 years STANDARD_DEVIATION 5 | 67.2 years STANDARD_DEVIATION 4.9 | 66.1 years STANDARD_DEVIATION 5 | 68.7 years STANDARD_DEVIATION 4.6 |
| Body Mass Index | 31.0 kg/m2 STANDARD_DEVIATION 2.9 | 31.7 kg/m2 STANDARD_DEVIATION 2.9 | 32.0 kg/m2 STANDARD_DEVIATION 2.9 | 31.7 kg/m2 STANDARD_DEVIATION 2.9 |
| eSPPB | 2.58 score STANDARD_DEVIATION 0.35 | 2.55 score STANDARD_DEVIATION 0.34 | 2.59 score STANDARD_DEVIATION 0.36 | 2.49 score STANDARD_DEVIATION 0.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 88 Participants | 32 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Grip Strength | 32.1 kg STANDARD_DEVIATION 8.8 | 31.4 kg STANDARD_DEVIATION 9.4 | 30.3 kg STANDARD_DEVIATION 7.8 | 32.1 kg STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 14 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 75 Participants | 28 Participants | 29 Participants |
| Screening Weight | 90.5 kg STANDARD_DEVIATION 11.9 | 90.3 kg STANDARD_DEVIATION 4.9 | 89.7 kg STANDARD_DEVIATION 12.7 | 90.8 kg STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 13 Participants | 56 Participants | 22 Participants | 21 Participants |
| Sex: Female, Male Male | 9 Participants | 34 Participants | 12 Participants | 13 Participants |
| Step Count per day | 7201 steps per day STANDARD_DEVIATION 2536 | 6962 steps per day STANDARD_DEVIATION 2514 | 7327 steps per day STANDARD_DEVIATION 2960 | 6411 steps per day STANDARD_DEVIATION 1888 |
| Total MoCA Score | 26.0 points STANDARD_DEVIATION 1.9 | 26.1 points STANDARD_DEVIATION 2 | 26.0 points STANDARD_DEVIATION 2.1 | 26.2 points STANDARD_DEVIATION 2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 20 / 22 | 31 / 34 | 29 / 34 |
| serious Total, serious adverse events | 1 / 22 | 2 / 34 | 2 / 34 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| In-Person Caloric Restriction Arm | Ability to Maintain Time Restricted Eating (TRE) Intervention | 83.5 % of days |
Primary
Number of Participants That Sustained >10% Caloric Restriction
Ability of participants to sustain Caloric Restriction \>10%
Time frame: Month 9
Population: The TRE Arm did not participate in caloric restriction and are not included in the outcome analysis. Only those participants with data from baseline and 9 months Doubly-Labeled water (DLW) are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| In-Person Caloric Restriction Arm | Number of Participants That Sustained >10% Caloric Restriction | 7 Participants |
| Remote Caloric Restriction Arm | Number of Participants That Sustained >10% Caloric Restriction | 12 Participants |
Primary
Number of Participants Who Were Retained
Retention \> 85%
Time frame: Month 9
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-Person Caloric Restriction Arm | Number of Participants Who Were Retained | 20 participants |
| Remote Caloric Restriction Arm | Number of Participants Who Were Retained | 34 participants |
| Time-Restricted Eating Arm | Number of Participants Who Were Retained | 29 participants |
Secondary
Body Weight Change
Assessed using home scales.
Time frame: From Baseline to Month 6, and From Baseline to 9 Months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| In-Person Caloric Restriction Arm | Body Weight Change | Change in Body Weight at 6 months | -4.47 kg | 95% Confidence Interval 6.44 |
| In-Person Caloric Restriction Arm | Body Weight Change | Change in Body Weight at 9 months | -4.44 kg | — |
| Remote Caloric Restriction Arm | Body Weight Change | Change in Body Weight at 6 months | -6.09 kg | 95% Confidence Interval 5.58 |
| Remote Caloric Restriction Arm | Body Weight Change | Change in Body Weight at 9 months | -6.66 kg | — |
| Time-Restricted Eating Arm | Body Weight Change | Change in Body Weight at 6 months | -1.35 kg | 95% Confidence Interval 4.37 |
| Time-Restricted Eating Arm | Body Weight Change | Change in Body Weight at 9 months | -0.94 kg | — |
Secondary
Change in Age-Related Biomarkers-- CRP From Serum
Change in C-reactive Protein, an Age-Related Biomarker that is used to detect inflammation in the body
Time frame: From Baseline to 9 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Age-Related Biomarkers-- CRP From Serum | 1.12 mg/L | Standard Deviation 4.47 |
| Remote Caloric Restriction Arm | Change in Age-Related Biomarkers-- CRP From Serum | 0.60 mg/L | Standard Deviation 4.95 |
| Time-Restricted Eating Arm | Change in Age-Related Biomarkers-- CRP From Serum | 1.20 mg/L | Standard Deviation 6.26 |
Secondary
Change in Age-Related Biomarkers--cystatin C
Change in cystatin C - An Age-Related Biomarker used to assess kidney function
Time frame: From Baseline to 9 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Age-Related Biomarkers--cystatin C | -0.10 mg/L | Standard Deviation 0.21 |
| Remote Caloric Restriction Arm | Change in Age-Related Biomarkers--cystatin C | -0.04 mg/L | Standard Deviation 0.14 |
| Time-Restricted Eating Arm | Change in Age-Related Biomarkers--cystatin C | -0.24 mg/L | Standard Deviation 1.12 |
Secondary
Change in Age-Related Biomarkers--Fasting Insulin
Fasting insulin, an age-related biomarker
Time frame: From Baseline to 9 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Age-Related Biomarkers--Fasting Insulin | -5.60 pmol/L | Standard Deviation 23.97 |
| Remote Caloric Restriction Arm | Change in Age-Related Biomarkers--Fasting Insulin | -12.41 pmol/L | Standard Deviation 19.91 |
| Time-Restricted Eating Arm | Change in Age-Related Biomarkers--Fasting Insulin | -2.06 pmol/L | Standard Deviation 24.26 |
Secondary
Change in Age-Related Biomarkers--interleukin-6 (IL-6)
Interleukin-6 (IL-6) is an Age-related biomarker, cytokine, and key mediator of inflammation
Time frame: From Baseline to 9 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Age-Related Biomarkers--interleukin-6 (IL-6) | 1.20 pg/mL | Standard Deviation 3.84 |
| Remote Caloric Restriction Arm | Change in Age-Related Biomarkers--interleukin-6 (IL-6) | -0.22 pg/mL | Standard Deviation 1.79 |
| Time-Restricted Eating Arm | Change in Age-Related Biomarkers--interleukin-6 (IL-6) | 0.30 pg/mL | Standard Deviation 2.12 |
Secondary
Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI)
Tumor Necrosis Factor Receptor 1 (TNRFI), an Age-Related Biomarker, is a protein that acts as a receptor for TNF-alpha, a cytokin involved in inflammation.
Time frame: From Baseline to 9 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI) | -3.80 pg/mL | Standard Deviation 204.73 |
| Remote Caloric Restriction Arm | Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI) | -55.12 pg/mL | Standard Deviation 281.33 |
| Time-Restricted Eating Arm | Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI) | -15.52 pg/mL | Standard Deviation 151.12 |
Secondary
Change in Bone Mineral Density
As assessed by DXA using the Hip BMD
Time frame: From Baseline to Month 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Bone Mineral Density | -0.01 g/cm2 | 95% Confidence Interval 0.02 |
| Remote Caloric Restriction Arm | Change in Bone Mineral Density | -0.01 g/cm2 | 95% Confidence Interval 0.03 |
| Time-Restricted Eating Arm | Change in Bone Mineral Density | -0.00 g/cm2 | 95% Confidence Interval 0.02 |
Secondary
Change in Cognitive Function--MoCA
Total score ranges from 0-30 with a higher score denoting better cognitive function.
Time frame: From baseline to Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Cognitive Function--MoCA | 1.20 score | Standard Deviation 2.28 |
| Remote Caloric Restriction Arm | Change in Cognitive Function--MoCA | 0.68 score | Standard Deviation 2.42 |
| Time-Restricted Eating Arm | Change in Cognitive Function--MoCA | 1.17 score | Standard Deviation 2.07 |
Secondary
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
Time frame: From Baseline to Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Energy Intake | -129.5 kcals per day | Standard Deviation 237.3 |
| Remote Caloric Restriction Arm | Change in Energy Intake | -133.6 kcals per day | Standard Deviation 228.7 |
| Time-Restricted Eating Arm | Change in Energy Intake | -45.6 kcals per day | Standard Deviation 171.8 |
Secondary
Change in Physical Activity Energy Expenditure
Assessed by ActivPAL
Time frame: From Baseline to Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Physical Activity Energy Expenditure | 0.42 kcals per day | Standard Deviation 1.26 |
| Remote Caloric Restriction Arm | Change in Physical Activity Energy Expenditure | 0.68 kcals per day | Standard Deviation 1.19 |
| Time-Restricted Eating Arm | Change in Physical Activity Energy Expenditure | 0.29 kcals per day | Standard Deviation 0.59 |
Secondary
Change in Resting Energy Expenditure
As assessed by Indirect Calorimetry between baseline and 9 months follow-up
Time frame: From Baseline to Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Change in Resting Energy Expenditure | -35.3 Kcal | Standard Deviation 221.4 |
| Remote Caloric Restriction Arm | Change in Resting Energy Expenditure | -74.1 Kcal | Standard Deviation 217.3 |
| Time-Restricted Eating Arm | Change in Resting Energy Expenditure | -94.8 Kcal | Standard Deviation 182.8 |
Secondary
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.
Time frame: From Baseline to Month 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| In-Person Caloric Restriction Arm | Change in Self-Reported Energy Intake | -371.4 kcals/day |
| Remote Caloric Restriction Arm | Change in Self-Reported Energy Intake | -244.1 kcals/day |
| Time-Restricted Eating Arm | Change in Self-Reported Energy Intake | -255.6 kcals/day |
Secondary
Change in Total Muscle Mass
The D3-Creatine (D3Cr) method used to assess total muscle mass is completed after the participant ingests a known amount of D3-creatine (creatine with deuterium atoms replacing hydrogens) and the labeled creatine is distributed throughout the body, with approximately 98% ending up in skeletal muscle. By measuring the ratio of labeled (D3-creatinine) to unlabeled creatinine in a urine sample the total body creatine pool can be determined and total muscle mass can be calculated.
Time frame: From Baseline to Month 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| In-Person Caloric Restriction Arm | Change in Total Muscle Mass | -1.46 kg |
| Remote Caloric Restriction Arm | Change in Total Muscle Mass | 0.64 kg |
| Time-Restricted Eating Arm | Change in Total Muscle Mass | 1.88 kg |
Secondary
Changes in Fat Mass
Assessed by (Dual-Energy X-Ray Absorptiometry) DXA.
Time frame: From Baseline to Month 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Changes in Fat Mass | -2.92 kg | 95% Confidence Interval 2.79 |
| Remote Caloric Restriction Arm | Changes in Fat Mass | -4.46 kg | 95% Confidence Interval 2.46 |
| Time-Restricted Eating Arm | Changes in Fat Mass | 0.02 kg | 95% Confidence Interval 1.53 |
Secondary
Changes in Lean Body Mass
As assessed by DXA for the total lean body mass.
Time frame: From Baseline to Month 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Changes in Lean Body Mass | -1.73 kg | 95% Confidence Interval 1.47 |
| Remote Caloric Restriction Arm | Changes in Lean Body Mass | -2.21 kg | 95% Confidence Interval 2.03 |
| Time-Restricted Eating Arm | Changes in Lean Body Mass | -0.59 kg | 95% Confidence Interval 1.63 |
Secondary
Physical Function--Change in eSPPB
Change in overall physical performance with total score ranging from 0 to 4 with a higher score denoting better physical function.
Time frame: From Baseline to Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Physical Function--Change in eSPPB | -0.10 score | Standard Deviation 0.34 |
| Remote Caloric Restriction Arm | Physical Function--Change in eSPPB | 0.08 score | Standard Deviation 0.26 |
| Time-Restricted Eating Arm | Physical Function--Change in eSPPB | -0.00 score | Standard Deviation 0.22 |
Secondary
Physical Function--Change in Grip Strength
measured in kg (0-90kg)
Time frame: From Baseline to Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Physical Function--Change in Grip Strength | -1.47 kg | Standard Deviation 4.34 |
| Remote Caloric Restriction Arm | Physical Function--Change in Grip Strength | -0.48 kg | Standard Deviation 4.67 |
| Time-Restricted Eating Arm | Physical Function--Change in Grip Strength | -0.38 kg | Standard Deviation 5.65 |
Secondary
Physical Function--Change in Walk Time
400m walk - assessed in number of seconds (unlimited time)
Time frame: From Baseline to Month 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Physical Function--Change in Walk Time | -7.05 seconds | 95% Confidence Interval 40.23 |
| Remote Caloric Restriction Arm | Physical Function--Change in Walk Time | -19.76 seconds | 95% Confidence Interval 26.81 |
| Time-Restricted Eating Arm | Physical Function--Change in Walk Time | -19.18 seconds | 95% Confidence Interval 17.58 |