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| ID | Type | Description | Link |
|---|---|---|---|
| U01AG073240 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person Caloric Restriction Arm | Experimental | 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 BodyTraceâ„¢ 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. |
|
| Remote Caloric Restriction Arm | Experimental | 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. |
|
| Time-Restricted Eating Arm | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-Person Caloric Restriction | Behavioral | 20% CR delivered in-person by dietitian/coach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Sustained >10% Caloric Restriction | Ability of participants to sustain Caloric Restriction >10% | 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. | Month 9 |
| Number of Participants Who Were Retained | Retention > 85% | Month 9 |
| 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 Mass | Assessed by (Dual-Energy X-Ray Absorptiometry) DXA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen B. Kritchevsky, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Barbara J. Nicklas, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Michael E. Miller, PhD | Wake Forest University Health Sciences | Principal Investigator |
| W. Jack Rejeski, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist Hospital | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40834924 | Derived | Stowe CL, Kennedy K, Emilson SS, Neiberg RH, Kritchevsky SB, Miller ME, Houston DK, Nicklas BJ, Fanning J, Rejeski WJ; HALLO-P Investigators. The Health, Aging, and Later-Life Outcomes Pilot Study: Design, recruitment, and participants' baseline characteristics. Contemp Clin Trials. 2025 Oct;157:108049. doi: 10.1016/j.cct.2025.108049. Epub 2025 Aug 18. |
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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.
Recruitment began in July 2022 at one clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 BodyTraceâ„¢ 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 BodyTraceâ„¢ 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Sustained >10% Caloric Restriction | Ability of participants to sustain Caloric Restriction >10% | 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. | Posted | Count of Participants | Participants | Month 9 |
|
AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 BodyTraceâ„¢ 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders - Other | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Stowe | Wake Forest University School of Medicine | 336-716-0686 | cynthia.stowe@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2023 | Aug 11, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2024 | Aug 2, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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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.
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Staff who will assess outcomes at follow up visits will be blinded to group assignment.
|
| Remote Caloric Restriction | Behavioral | 20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely. |
|
| Time-restricted | 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. |
|
| From Baseline to Month 9 |
| Changes in Lean Body Mass | As assessed by DXA for the total lean body mass. | From Baseline to Month 9 |
| Change in Bone Mineral Density | As assessed by DXA using the Hip BMD | From Baseline to Month 9 |
| Change in Resting Energy Expenditure | As assessed by Indirect Calorimetry between baseline and 9 months follow-up | 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 | 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. | 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 number of seconds (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 4 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 | Fasting insulin, an age-related biomarker | From Baseline to 9 Months |
| Change in Age-Related Biomarkers--interleukin-6 (IL-6) | Interleukin-6 (IL-6) is an Age-related biomarker, cytokine, and key mediator of inflammation | From Baseline to 9 Months |
| 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. | From Baseline to 9 Months |
| Change in Age-Related Biomarkers--cystatin C | Change in cystatin C - An Age-Related Biomarker used to assess kidney function | From Baseline to 9 Months |
| 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 | From Baseline to 9 Months |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Screening Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Total MoCA Score | Montreal Cognitive Assessment (MoCA): The MoCA questionnaire is used to exclude any participant with impaired cognition that would preclude them from participating. The MoCA test is a 30-point test administered in approximately 10 minutes which assesses several cognitive domains including short-term memory recall task, visuospatial abilities, executive functions, attention, concentration, and working memory, language, and orientation to time. A score <22 would exclude the participant. | Mean | Standard Deviation | points |
|
| Grip Strength | Mean | Standard Deviation | kg |
|
| Step Count per day | Mean | Standard Deviation | steps per day |
|
| eSPPB | The expanded Short Physical Performance Battery consists of standing balance tasks (side-by-side, semi- and full-tandem stands), a 4-m walk to assess usual gait speed, and time to complete 5 repeated chair stands. The SPPB was expanded to increase the holding time of the standing balance tasks from 10 to 30 seconds and added a single leg stand and a narrow walk test of balance to minimize ceiling effects of the SPPB. The eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance | Mean | Standard Deviation | score |
|
| 400 meter Fast Walk Time | Mean | Standard Deviation | seconds |
|
| OG001 | 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. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | % of days | Month 9 |
|
|
|
| Primary | Number of Participants Who Were Retained | Retention > 85% | Posted | Number | participants | Month 9 |
|
|
|
| Secondary | Body Weight Change | Assessed using home scales. | Posted | Least Squares Mean | 95% Confidence Interval | kg | From Baseline to Month 6, and From Baseline to 9 Months |
|
|
|
| Secondary | Changes in Fat Mass | Assessed by (Dual-Energy X-Ray Absorptiometry) DXA. | Posted | Least Squares Mean | 95% Confidence Interval | kg | From Baseline to Month 9 |
|
|
|
| Secondary | Changes in Lean Body Mass | As assessed by DXA for the total lean body mass. | Posted | Least Squares Mean | 95% Confidence Interval | kg | From Baseline to Month 9 |
|
|
|
| Secondary | Change in Bone Mineral Density | As assessed by DXA using the Hip BMD | Posted | Least Squares Mean | 95% Confidence Interval | g/cm2 | From Baseline to Month 9 |
|
|
|
| Secondary | Change in Resting Energy Expenditure | As assessed by Indirect Calorimetry between baseline and 9 months follow-up | Posted | Mean | Standard Deviation | Kcal | From Baseline to Month 9 |
|
|
|
| Secondary | Change in Physical Activity Energy Expenditure | Assessed by ActivPAL | Posted | Mean | Standard Deviation | kcals per day | From Baseline to Month 9 |
|
|
|
| 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 | Posted | Oct 2025 | Mean | Standard Deviation | kcals per day | From Baseline to Month 9 |
|
|
|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | kg | From Baseline to Month 9 |
|
|
|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | kcals/day | From Baseline to Month 9 |
|
|
|
| Secondary | Physical Function--Change in Walk Time | 400m walk - assessed in number of seconds (unlimited time) | Posted | Least Squares Mean | 95% Confidence Interval | seconds | From Baseline to Month 9 |
|
|
|
| Secondary | Physical Function--Change in Grip Strength | measured in kg (0-90kg) | Posted | Mean | Standard Deviation | kg | From Baseline to Month 9 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score | From Baseline to Month 9 |
|
|
|
| Secondary | Change in Cognitive Function--MoCA | Total score ranges from 0-30 with a higher score denoting better cognitive function. | Posted | Mean | Standard Deviation | score | From baseline to Month 9 |
|
|
|
| Secondary | Change in Age-Related Biomarkers--Fasting Insulin | Fasting insulin, an age-related biomarker | Posted | Mean | Standard Deviation | pmol/L | From Baseline to 9 Months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | pg/mL | From Baseline to 9 Months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | pg/mL | From Baseline to 9 Months |
|
|
|
| Secondary | Change in Age-Related Biomarkers--cystatin C | Change in cystatin C - An Age-Related Biomarker used to assess kidney function | Posted | Mean | Standard Deviation | mg/L | From Baseline to 9 Months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/L | From Baseline to 9 Months |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| 20 |
| 22 |
| EG001 | 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. | 0 | 34 | 2 | 34 | 31 | 34 |
| EG002 | 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. | 0 | 34 | 2 | 34 | 29 | 34 |
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Transient ischemic attacks | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Surgical and medical procedures - Other | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | MedDRA | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Bronchial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gum infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Shingles | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Pelvic floor muscle weakness | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Surgical and medical procedures - Other | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Vascular disorders - Other | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Eye disorders - Other | Eye disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA | Systematic Assessment |
|
| Bronchial infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gum infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nervous system disorders - other | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Surgical and medical procedures - Other | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| Change in Body Weight at 9 months |
|