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Diabetes is a major health concern in obese older Veterans, especially in those who are African American. The negative impact of diabetes on muscle and physical function contributes to metabolic as well as physical decline and is under-studied. This randomized controlled trial compares a higher-protein, weight loss regimen previously shown to improve physical function to an Recommended Dietary Allowance (RDA) protein intervention in obese older male Veterans with pre-diabetes and functional limitations. Equal numbers of white and black male Veterans will be studied, filling gaps in the investigators' knowledge of differential responses by race as well as obesity interventions for men in general. The primary outcome is functional performance by Short Physical Performance Battery and secondary measures include muscle quantity and composition, glucose handling, lean body mass, recent falls and fear of falling, and quality of life measured at 0, 3 and 6 months. The goal of this research is to accelerate functional recovery and enhance independence in obese male Veterans, which is strongly aligned with the VA mission to "maximize the physical and social autonomy of Veterans".
This study examines an evidence-based obesity intervention as a means of reducing the impact of prediabetes on muscle function in obese older men of white and black race. A total of 64 obese (BMI 30 kg/m2) male Veterans aged 55 + yrs, with mild to moderate functional impairments (Short Physical Performance Battery score of 4 to 11 units) and prediabetes, will be randomized to a higher-protein weight loss treatment (HP-WL) or an RDA-level protein control weight loss treatment (C-WL). All participants receive individualized calorie prescriptions calculated to achieve a weight loss of ~1-2 pounds per week and attend weekly group support sessions designed to enhance diet compliance with goal setting, self-monitoring, stress management, and daily diet journaling. They will also attend a weekly low impact, chair exercise class. HP-WL participants are provided a supply of chilled/frozen high-quality protein foods (lean meats, low fat dairy products) sufficient to give 30 g high quality protein for two of three meals daily to help assure diet compliance. C-WL participants are provided 1 serving per day of high quality protein to avoid unintentional bias. Treatment responses will be compared for the primary outcome of functional performance by Short Physical Performance Battery and important secondary measures, including muscle quantity and composition, glucose handling, lean body mass, recent falls and fear of falling, and quality of life at 0, 3 and 6 months. An exploratory aim examines potential mediators of racial differences in treatment responses and documents the most successful intervention strategies. This randomized controlled trial of a balanced, higher-protein diet during a metabolic challenge (caloric restriction) in those with prediabetes also considers racial differences in responses of obese older men to this regimen. Study findings will fulfill the RR&D mission by advancing interventions to improve physical function in older Veterans, yield novel information about the impact of balanced, higher protein on muscle and glucose handling, and explore racial differences in responses to obesity interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WL-Control | Experimental | 0.8 g protein per kg body weight. Seven servings of whey protein powder (15 g/serving) per week will be provided to participants to support diet affordability. |
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| WL-Protein | Experimental | >30 g of high quality protein per meal, 1.4 g protein/kg body weight/day. 21 servings of high quality (30 g/serving) protein (lean meats, whey protein powder, protein drinks) provided to participants each week to increase compliance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foods rich in high quality protein | Dietary Supplement | Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). |
| Measure | Description | Time Frame |
|---|---|---|
| Total Short Physical Performance Battery (SPPB) Score at Baseline | SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning. | 0 months |
| Change in Total Short Physical Performance Battery (SPPB) Score at 3 Months | SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning. The change score is determined by the value at 3 months minus the value at baseline. | Baseline and 3 months |
| Change in Total Short Physical Performance Battery (SPPB) Score at 6 Months | SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning. The change score is determined by the value at 6 months minus the value at baseline. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight at 3 Months | Body weight was measured on the same scale, with light clothing and no shoes, measured to nearest 0.1 lbs. Percent change in body weight was calculated by subtracting weight at 3 months from weight at baseline, dividing by weight at baseline, and multiplying by 100. | Baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Presence of unstable or symptomatic life-threatening illness
Glomerular filtration rates (GFR) less than 45 mL/min
Mini Cog score of <3
--Vegetarian
Neurological conditions causing functional impairments, including:
Inability to complete physical function assessment
History of significant weight instability
Contraindicated medications, including narcotic mail-outs and active substance abuse
Any psychiatric condition that would prevent the subject from participating in a group intervention setting, including diagnosed personality disorders
Primary care provider disapproves participation
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| Name | Affiliation | Role |
|---|---|---|
| Connie W Bales, PhD RD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
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SPPB and A1c or fasting glucose collected after consent were part of eligibility criteria. Of 105 enrolled participants, 64 met inclusion criteria and were randomized in the trial.
Participants were recruited based on medical record queries and letters and at Veteran organizations between September 2019 and October 2023. The first participant was enrolled on 12/12/2019 and the last participant was enrolled on 10/27/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | WL-Control | 0.8 g protein per kg body weight. Seven servings of whey protein powder (15 g/serving) per week will be provided to participants to support diet affordability. Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). |
| FG001 | WL-Protein | >30 g of high quality protein per meal, 1.4 g protein/kg body weight/day. 21 servings of high quality (30 g/serving) protein (lean meats, whey protein powder, protein drinks) provided to participants each week to increase compliance. Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | WL-Control | 0.8 g protein per kg body weight. Seven servings of whey protein powder (15 g/serving) per week will be provided to participants to support diet affordability. Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Total Short Physical Performance Battery (SPPB) Score at Baseline | SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning. | Posted | Mean | Standard Deviation | score on a scale | 0 months |
|
From time of consent to completion of either 3 month or 6 month study, 4-7 months
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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 | WL-Control | 0.8 g protein per kg body weight. Seven servings of whey protein powder (15 g/serving) per week will be provided to participants to support diet affordability. Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Identified while in study |
The outcomes for which data are missing have the following explanations:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Connie Bales, Assoc. Director, GRECC | Durham VA Medical Center | 919-286-0411 | 6780 | connie.bales@va.gov |
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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 | Dec 13, 2023 | Feb 6, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 6, 2023 | Jan 5, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Two-armed Randomized Controlled Trial. Control group follows RDA-level (0.8 g/kg bw/d)protein weight loss diet. Protein follows higher protein (1.4 g/kg bw/d) weight loss diet with balanced protein at each meal.
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Those responsible for outcomes assessment will be blinded from group treatment arm to every extent possible.
| Percent Change in Body Weight at 6 Months |
Body weight was measured on the same scale, with light clothing and no shoes, measured to nearest 0.1 lbs. Percent change in body weight was calculated by subtracting weight at 6 months from weight at baseline, dividing by weight at baseline, and multiplying by 100. |
| Baseline and 6 months |
| Change in 6 Minute Walk Test (Aerobic Endurance) at 3 Months | Meters walked in six minutes on a designated course. Change in meters walked was calculated by subtracting meters walked at 3 months from meters walked at baseline. | Baseline and 3 months |
| Change in 6 Minute Walk Test (Aerobic Endurance) at 6 Months | Meters walked in six minutes on a designated course. Change in meters walked was calculated by subtracting meters walked at 6 months from meters walked at baseline. | 6 months |
| Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 3 Months | Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated. Timing starts on 'go' and ends when seated. Change in time walked was calculated by subtracting time walked at 3 months from time walked at baseline. | Baseline and 3 months |
| Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 6 Months | Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated. Timing starts on 'go' and ends when seated. Change in time walked was calculated by subtracting time walked at 6 months from time walked at baseline. | Baseline and 6 months |
| Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 3 Months | With arms across chest, stand up completely and return to seated as many times as possible in 30 seconds. Change in number of chair stands was calculated by subtracting number of chair stands at 3 months from number of chair stands at baseline. | Baseline and 3 months |
| Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 6 Months | With arms across chest, stand up completely and return to seated as many times as possible in 30 seconds. Change in number of chair stands was calculated by subtracting number of chair stands at 6 months from number of chair stands at baseline. | Baseline and 6 months |
| Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 3 Months | Knee extensor at 60 degrees with a dynamometer. Average peak torque for three trials will be recorded. Change in peak torque was calculated by subtracting peak torque at 3 months from peak torque at baseline. | Baseline and 3 months |
| Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 6 Months | Knee extensor at 60 degrees with a dynamometer. Average peak torque for three trials will be recorded. Change in peak torque was calculated by subtracting peak torque at 6 months from peak torque at baseline. | Baseline and 6 months |
| Change in Isometric Hand Grip (Upper Body Strength) at 3 Months | Using the Jamar Hand Dynamometer, the amount of pressure placed when squeezing the instrument as hard as possible was measured. Two trials per hand were measured. Change in hand grip was calculated by subtracting the highest value at 3 months from the highest value at baseline. | Baseline and 3 months |
| Change in Isometric Hand Grip (Upper Body Strength) at 6 Months | Using the Jamar Hand Dynamometer, the amount of pressure placed when squeezing the instrument as hard as possible was measured. Two trials per hand were measured. Change in hand grip was calculated by subtracting the highest value at 6 months from the highest value at baseline. | Baseline and 6 months |
| Change in Minimal Waist Circumference at 3 Months | Minimal waist circumference was measured at smallest horizontal circumference above umbilicus and below xiphoid process. Change in minimal waist circumference was calculated by subtracting the measurement at 3 months from the measurement at baseline. | Baseline and 3 months |
| Change in Minimal Waist Circumference at 6 Months | Minimal waist circumference was measured at smallest horizontal circumference above umbilicus and below xiphoid process. Change in minimal waist circumference was calculated by subtracting the measurement at 6 months from the measurement at baseline. | Baseline and 6 months |
| Change in Body Composition: Percent Lean Mass at 3 Months | Air displacement plethysmography method (Life Measurement, Inc., Concord, CA). The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population. Percent lean mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent lean mass was calculated by subtracting the percent lean mass at 3 months from the percent lean mass at baseline. | Baseline and 3 months |
| Change in Body Composition: Percent Lean Mass at 6 Months | Air displacement plethysmography method (Life Measurement, Inc., Concord, CA). The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population. Percent lean mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent lean mass was calculated by subtracting the percent lean mass at 6 months from the percent lean mass at baseline. | Baseline and 6 months |
| Change in Body Composition: Percent Fat Mass at 3 Months | Air displacement plethysmography method (Life Measurement, Inc., Concord, CA). The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population. Percent fat mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent fat mass was calculated by subtracting the percent fat mass at 3 months from the percent fat mass at baseline. | Baseline and 3 months |
| Change in Body Composition: Percent Fat Mass at 6 Months | Air displacement plethysmography method (Life Measurement, Inc., Concord, CA). The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population. Percent fat mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent fat mass was calculated by subtracting the percent fat mass at 6 months from the percent fat mass at baseline. | Baseline and 6 months |
| Mini-Cog at Baseline Only | To assess for cognitive impairment, the mini cog was used to screen for eligibility at baseline only. The mini cog includes two components - a 3-item recall and a clock drawing. You can score 0-3 points for the 3-item recall, and 0-2 points for the clock drawing. These subscale scores are summed for a total possible score of 5. Subscale scores were not reported, only the total score. The total score is a range of 0-5. The max total score is 5 with 5 being the best score. To be eligible for the study, the total item recall and clock score needed to be 3 or higher. | Baseline only |
| Change in Computerized Axial Tomography (CAT) Scan at 3 Months | Cross sectional area of the thigh to determine thigh muscle mass. Change in area calculated by subtracting area at 3 months from area at baseline. | Baseline and 3 months |
| Change in Computerized Axial Tomography (CAT) Scan at 6 Months | Cross sectional area of the thigh to determine thigh muscle mass. Change in area calculated by subtracting area at 6 Months from area at baseline. | Baseline and 6 months |
| Change in Short Form-36 (SF-36) Health Survey at 3 Months | Quality of Life Questionnaires The SF-36 measures 8 QOL domains which are dichotomized into physical (functioning, role limitations-physical, pain, general health) and mental health (vitality, social functioning, role limitations-emotional, and emotional/mental health). Item scores were converted to a 0-100 point scale; domain scores were derived by averaging individual items within the subscale; and physical composite and mental health composite scores were derived by averaging the four component domains of each. Higher values are indicative of better QOL. Change in score calculated by subtracting score at 3 months from score at baseline. | Baseline and 3 months |
| Change in Short Form-36 (SF-36) Health Survey at 6 Months | Quality of Life Questionnaires The SF-36 measures 8 QOL domains which are dichotomized into physical (functioning, role limitations-physical, pain, general health) and mental health (vitality, social functioning, role limitations-emotional, and emotional/mental health). Item scores were converted to a 0-100 point scale; domain scores were derived by averaging individual items within the subscale; and physical composite and mental health composite scores were derived by averaging the four component domains of each. Higher values are indicative of better QOL. Change in score calculated by subtracting score at 6 months from score at baseline. | Baseline and 6 months |
| Change in Profile of Mood States (POMS) at 3 Months | Mood Questionnaires The 30-item POMS measures mood and mood changes, has low respondent burden, and includes 6 subscales: tension, depression, anger, fatigue, confusion and vigor (all with range 0-20). Total mood disturbance (TMD) is derived from POMS using the following formula, TMD = (Sum of all subscales except vigor) - vigor (range -20 - 100). Change in score calculated by subtracting score at 3 months from score at baseline. | Baseline and 3 months |
| Change in Profile of Mood States (POMS) at 6 Months | Mood Questionnaires The 30-item POMS measures mood and mood changes, has low respondent burden, and includes 6 subscales: tension, depression, anger, fatigue, confusion and vigor (all with range 0-20). Total mood disturbance (TMD) is derived from POMS using the following formula, TMD = (Sum of all subscales except vigor) - vigor (range -20 - 100). Change in score calculated by subtracting score at 6 months from score at baseline. | Baseline and 6 months |
| Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 3 Months | Depression Questionnaires Individuals were coded as positive for depression if they had a CES-D score of 16 and/or had self-report of depression diagnosis at baseline. In addition to the total score, the CES-D includes 4 subscales: depressed affect (range 0-21), positive affect (range 0-12), somatic (range 0-21), and interpersonal (range 0-6). Change in score calculated by subtracting score at 3 months from score at baseline. | Baseline and 3 months |
| Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 6 Months | Depression Questionnaires Individuals were coded as positive for depression if they had a CES-D score of 16 and/or had self-report of depression diagnosis at baseline. In addition to the total score, the CES-D includes 4 subscales: depressed affect (range 0-21), positive affect (range 0-12), somatic (range 0-21), and interpersonal (range 0-6). Change in score calculated by subtracting score at 6 months from score at baseline. | Baseline and 6 months |
| Change in Perceived Stress Scale (PSS) at 3 Months | Stress Questionnaires The PSS assesses the degree to which situations in one's life are considered stressful (range 0-40). Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. Change in score calculated by subtracting score at 3 months from score at baseline. | Baseline and 3 months |
| Change in Perceived Stress Scale (PSS) at 6 Months | Stress Questionnaires The PSS assesses the degree to which situations in one's life are considered stressful (range 0-40). Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. Change in score calculated by subtracting score at 6 months from score at baseline. | Baseline and 6 months |
| Change in Pittsburgh Sleep Quality Index (PSQI) and 3 Months | Quality of sleep Questionnaires Reported PSQI values include only these six component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, and use of sleeping medication (all with a range 0-3). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Change in score calculated by subtracting score at 3 months from score at baseline. | Baseline and 3 months |
| Change in Pittsburgh Sleep Quality Index (PSQI) and 6 Months | Quality of sleep Questionnaires Reported PSQI values include only these six component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, and use of sleeping medication (all with a range 0-3). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Change in score calculated by subtracting score at 6 months from score at baseline. | Baseline and 6 months |
| Change in Satisfaction With Life Scale (SWLS) at 3 Months | Life Satisfaction Questionnaires The SWLS evaluates global life satisfaction, an important component of subjective well-being (range 5-35). The SWLS is a 7-point Likert scale style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied. Change in score calculated by subtracting score at 3 months from score at baseline. | Baseline and 3 months |
| Change in Satisfaction With Life Scale (SWLS) at 6 Months | Life Satisfaction Questionnaires The SWLS evaluates global life satisfaction, an important component of subjective well-being (range 5-35). The SWLS is a 7-point Likert scale style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied. Change in score calculated by subtracting score at 6 months from score at baseline. | Baseline and 6 months |
| Change in Hemoglobin A1c at 3 Months | Blood assay (LabCorp). Change in value calculated by subtracting value at 3 months from value at baseline. | Baseline and 3 months |
| Change in Hemoglobin A1c at 6 Months | Blood assay (LabCorp). Change in value calculated by subtracting value at 6 months from value at baseline. | Baseline and 6 months |
| Change in Fear of Falling at 3 Months | "Yes" responses to the question, "Do you have a fear of falling?" Change in number of "yes" answers from baseline to 3 months. Change was calculated by subtracting the number of "yes" answers at 3 months from the number of "yes" answers at baseline. | Baseline and 3 months |
| Change in Fear of Falling at 6 Months | "Yes" responses to the question, "Do you have a fear of falling?" Change in number of "yes" answers from baseline to 6 months. Change was calculated by subtracting the number of "yes" answers at 6 months from the number of "yes" answers at baseline. | Baseline and 6 months |
| Change in Number of Falls at 3 Months | This is an open-ended questionnaire to see the change in number of times a person falls between time points. Change in value calculated by subtracting value at 3 months from value at baseline. | Baseline and 3 months |
| Change in Number of Falls at 6 Months | This is an open-ended questionnaire to see the change in number of times a person falls between time points. Change in value calculated by subtracting value at 6 months from value at baseline. | Baseline and 6 months |
| Change in 3-day Diet Record, Calories, at 3 Months | 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in calories calculated by subtracting average daily calories at 3 months from average daily calories at baseline. | Baseline and 3 months |
| Change in 3-day Diet Record, Calories, at 6 Months | 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in calories calculated by subtracting average daily calories at 6 months from average daily calories at baseline. | Baseline and 6 months |
| Change in 3-day Diet Record, Protein, at 3 Months | 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in protein in grams calculated by subtracting average daily protein in grams at 3 months from average daily protein in grams at baseline. | Baseline and 3 months |
| Change in 3-day Diet Record, Protein, at 6 Months | 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in protein in grams calculated by subtracting average daily protein in grams at 6 months from average daily protein in grams at baseline. | Baseline and 6 months |
| Number of Participants Measured Using an Axis Accelerometer (Actigraph) | Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at baseline. | Baseline |
| Number of Participants Measured Using an Axis Accelerometer (Actigraph) | Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at 3 months. | 3 months |
| Number of Participants Measured Using an Axis Accelerometer (Actigraph) | Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at 6 months. | 6 months |
| Change in Glucose Tolerance Test (OGTT) (78-80), Blood | Ingestion of a 75 g glucose load | 3 months |
| Change in Glucose Tolerance Test (OGTT) (78-80), Blood | Ingestion of a 75 g glucose load | 6 months |
| Percent Attendance at Weekly Diet Class Between Baseline and 3 Months | Attendance counted if in person or virtual. Percentage calculated by dividing number of classes attended by number of classes held and multiplying by 100. | Baseline and 3 months |
| Percent Attendance at Weekly Diet Class Between Baseline and 6 Months | Attendance counted if in person or virtual. Percentage calculated by dividing number of classes attended by number of classes held and multiplying by 100. | Baseline and 6 months |
| BG001 | WL-Protein | >30 g of high quality protein per meal, 1.4 g protein/kg body weight/day. 21 servings of high quality (30 g/serving) protein (lean meats, whey protein powder, protein drinks) provided to participants each week to increase compliance. Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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>30 g of high quality protein per meal, 1.4 g protein/kg body weight/day. 21 servings of high quality (30 g/serving) protein (lean meats, whey protein powder, protein drinks) provided to participants each week to increase compliance.
Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description).
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| Primary | Change in Total Short Physical Performance Battery (SPPB) Score at 3 Months | SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning. The change score is determined by the value at 3 months minus the value at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
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| Primary | Change in Total Short Physical Performance Battery (SPPB) Score at 6 Months | SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning. The change score is determined by the value at 6 months minus the value at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Secondary | Percent Change in Body Weight at 3 Months | Body weight was measured on the same scale, with light clothing and no shoes, measured to nearest 0.1 lbs. Percent change in body weight was calculated by subtracting weight at 3 months from weight at baseline, dividing by weight at baseline, and multiplying by 100. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | percent change in body weight | Baseline and 3 months |
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| Secondary | Percent Change in Body Weight at 6 Months | Body weight was measured on the same scale, with light clothing and no shoes, measured to nearest 0.1 lbs. Percent change in body weight was calculated by subtracting weight at 6 months from weight at baseline, dividing by weight at baseline, and multiplying by 100. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | percent change of body weight | Baseline and 6 months |
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| Secondary | Change in 6 Minute Walk Test (Aerobic Endurance) at 3 Months | Meters walked in six minutes on a designated course. Change in meters walked was calculated by subtracting meters walked at 3 months from meters walked at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | meters | Baseline and 3 months |
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| Secondary | Change in 6 Minute Walk Test (Aerobic Endurance) at 6 Months | Meters walked in six minutes on a designated course. Change in meters walked was calculated by subtracting meters walked at 6 months from meters walked at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | meters | 6 months |
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| Secondary | Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 3 Months | Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated. Timing starts on 'go' and ends when seated. Change in time walked was calculated by subtracting time walked at 3 months from time walked at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | seconds | Baseline and 3 months |
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| Secondary | Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 6 Months | Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated. Timing starts on 'go' and ends when seated. Change in time walked was calculated by subtracting time walked at 6 months from time walked at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | seconds | Baseline and 6 months |
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| Secondary | Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 3 Months | With arms across chest, stand up completely and return to seated as many times as possible in 30 seconds. Change in number of chair stands was calculated by subtracting number of chair stands at 3 months from number of chair stands at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 6 Months | With arms across chest, stand up completely and return to seated as many times as possible in 30 seconds. Change in number of chair stands was calculated by subtracting number of chair stands at 6 months from number of chair stands at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 3 Months | Knee extensor at 60 degrees with a dynamometer. Average peak torque for three trials will be recorded. Change in peak torque was calculated by subtracting peak torque at 3 months from peak torque at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | newton-meters | Baseline and 3 months |
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| Secondary | Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 6 Months | Knee extensor at 60 degrees with a dynamometer. Average peak torque for three trials will be recorded. Change in peak torque was calculated by subtracting peak torque at 6 months from peak torque at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | newton-meters | Baseline and 6 months |
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| Secondary | Change in Isometric Hand Grip (Upper Body Strength) at 3 Months | Using the Jamar Hand Dynamometer, the amount of pressure placed when squeezing the instrument as hard as possible was measured. Two trials per hand were measured. Change in hand grip was calculated by subtracting the highest value at 3 months from the highest value at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | kilograms | Baseline and 3 months |
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| Secondary | Change in Isometric Hand Grip (Upper Body Strength) at 6 Months | Using the Jamar Hand Dynamometer, the amount of pressure placed when squeezing the instrument as hard as possible was measured. Two trials per hand were measured. Change in hand grip was calculated by subtracting the highest value at 6 months from the highest value at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | kilograms | Baseline and 6 months |
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| Secondary | Change in Minimal Waist Circumference at 3 Months | Minimal waist circumference was measured at smallest horizontal circumference above umbilicus and below xiphoid process. Change in minimal waist circumference was calculated by subtracting the measurement at 3 months from the measurement at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | centimeters | Baseline and 3 months |
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| Secondary | Change in Minimal Waist Circumference at 6 Months | Minimal waist circumference was measured at smallest horizontal circumference above umbilicus and below xiphoid process. Change in minimal waist circumference was calculated by subtracting the measurement at 6 months from the measurement at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | centimeters | Baseline and 6 months |
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| Secondary | Change in Body Composition: Percent Lean Mass at 3 Months | Air displacement plethysmography method (Life Measurement, Inc., Concord, CA). The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population. Percent lean mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent lean mass was calculated by subtracting the percent lean mass at 3 months from the percent lean mass at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | change in total lean mass percentage | Baseline and 3 months |
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| Secondary | Change in Body Composition: Percent Lean Mass at 6 Months | Air displacement plethysmography method (Life Measurement, Inc., Concord, CA). The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population. Percent lean mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent lean mass was calculated by subtracting the percent lean mass at 6 months from the percent lean mass at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | change in total lean mass percentage | Baseline and 6 months |
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| Secondary | Change in Body Composition: Percent Fat Mass at 3 Months | Air displacement plethysmography method (Life Measurement, Inc., Concord, CA). The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population. Percent fat mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent fat mass was calculated by subtracting the percent fat mass at 3 months from the percent fat mass at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | change in total body fat mass percentage | Baseline and 3 months |
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| Secondary | Change in Body Composition: Percent Fat Mass at 6 Months | Air displacement plethysmography method (Life Measurement, Inc., Concord, CA). The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population. Percent fat mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent fat mass was calculated by subtracting the percent fat mass at 6 months from the percent fat mass at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | change in total body fat mass percentage | Baseline and 6 months |
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| Secondary | Mini-Cog at Baseline Only | To assess for cognitive impairment, the mini cog was used to screen for eligibility at baseline only. The mini cog includes two components - a 3-item recall and a clock drawing. You can score 0-3 points for the 3-item recall, and 0-2 points for the clock drawing. These subscale scores are summed for a total possible score of 5. Subscale scores were not reported, only the total score. The total score is a range of 0-5. The max total score is 5 with 5 being the best score. To be eligible for the study, the total item recall and clock score needed to be 3 or higher. | Posted | Mean | Standard Deviation | score on a scale | Baseline only |
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| Secondary | Change in Computerized Axial Tomography (CAT) Scan at 3 Months | Cross sectional area of the thigh to determine thigh muscle mass. Change in area calculated by subtracting area at 3 months from area at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Mean | Standard Deviation | cm^2 | Baseline and 3 months |
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| Secondary | Change in Computerized Axial Tomography (CAT) Scan at 6 Months | Cross sectional area of the thigh to determine thigh muscle mass. Change in area calculated by subtracting area at 6 Months from area at baseline. | A small number of participants do not have this measurement due to COVID-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Mean | Standard Deviation | cm^2 | Baseline and 6 months |
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| Secondary | Change in Short Form-36 (SF-36) Health Survey at 3 Months | Quality of Life Questionnaires The SF-36 measures 8 QOL domains which are dichotomized into physical (functioning, role limitations-physical, pain, general health) and mental health (vitality, social functioning, role limitations-emotional, and emotional/mental health). Item scores were converted to a 0-100 point scale; domain scores were derived by averaging individual items within the subscale; and physical composite and mental health composite scores were derived by averaging the four component domains of each. Higher values are indicative of better QOL. Change in score calculated by subtracting score at 3 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Short Form-36 (SF-36) Health Survey at 6 Months | Quality of Life Questionnaires The SF-36 measures 8 QOL domains which are dichotomized into physical (functioning, role limitations-physical, pain, general health) and mental health (vitality, social functioning, role limitations-emotional, and emotional/mental health). Item scores were converted to a 0-100 point scale; domain scores were derived by averaging individual items within the subscale; and physical composite and mental health composite scores were derived by averaging the four component domains of each. Higher values are indicative of better QOL. Change in score calculated by subtracting score at 6 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Profile of Mood States (POMS) at 3 Months | Mood Questionnaires The 30-item POMS measures mood and mood changes, has low respondent burden, and includes 6 subscales: tension, depression, anger, fatigue, confusion and vigor (all with range 0-20). Total mood disturbance (TMD) is derived from POMS using the following formula, TMD = (Sum of all subscales except vigor) - vigor (range -20 - 100). Change in score calculated by subtracting score at 3 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Profile of Mood States (POMS) at 6 Months | Mood Questionnaires The 30-item POMS measures mood and mood changes, has low respondent burden, and includes 6 subscales: tension, depression, anger, fatigue, confusion and vigor (all with range 0-20). Total mood disturbance (TMD) is derived from POMS using the following formula, TMD = (Sum of all subscales except vigor) - vigor (range -20 - 100). Change in score calculated by subtracting score at 6 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 3 Months | Depression Questionnaires Individuals were coded as positive for depression if they had a CES-D score of 16 and/or had self-report of depression diagnosis at baseline. In addition to the total score, the CES-D includes 4 subscales: depressed affect (range 0-21), positive affect (range 0-12), somatic (range 0-21), and interpersonal (range 0-6). Change in score calculated by subtracting score at 3 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 6 Months | Depression Questionnaires Individuals were coded as positive for depression if they had a CES-D score of 16 and/or had self-report of depression diagnosis at baseline. In addition to the total score, the CES-D includes 4 subscales: depressed affect (range 0-21), positive affect (range 0-12), somatic (range 0-21), and interpersonal (range 0-6). Change in score calculated by subtracting score at 6 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Perceived Stress Scale (PSS) at 3 Months | Stress Questionnaires The PSS assesses the degree to which situations in one's life are considered stressful (range 0-40). Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. Change in score calculated by subtracting score at 3 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Perceived Stress Scale (PSS) at 6 Months | Stress Questionnaires The PSS assesses the degree to which situations in one's life are considered stressful (range 0-40). Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. Change in score calculated by subtracting score at 6 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) and 3 Months | Quality of sleep Questionnaires Reported PSQI values include only these six component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, and use of sleeping medication (all with a range 0-3). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Change in score calculated by subtracting score at 3 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) and 6 Months | Quality of sleep Questionnaires Reported PSQI values include only these six component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, and use of sleeping medication (all with a range 0-3). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Change in score calculated by subtracting score at 6 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Satisfaction With Life Scale (SWLS) at 3 Months | Life Satisfaction Questionnaires The SWLS evaluates global life satisfaction, an important component of subjective well-being (range 5-35). The SWLS is a 7-point Likert scale style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied. Change in score calculated by subtracting score at 3 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Satisfaction With Life Scale (SWLS) at 6 Months | Life Satisfaction Questionnaires The SWLS evaluates global life satisfaction, an important component of subjective well-being (range 5-35). The SWLS is a 7-point Likert scale style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied. Change in score calculated by subtracting score at 6 months from score at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Hemoglobin A1c at 3 Months | Blood assay (LabCorp). Change in value calculated by subtracting value at 3 months from value at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Hemoglobin A1c at 6 Months | Blood assay (LabCorp). Change in value calculated by subtracting value at 6 months from value at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Fear of Falling at 3 Months | "Yes" responses to the question, "Do you have a fear of falling?" Change in number of "yes" answers from baseline to 3 months. Change was calculated by subtracting the number of "yes" answers at 3 months from the number of "yes" answers at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Fear of Falling at 6 Months | "Yes" responses to the question, "Do you have a fear of falling?" Change in number of "yes" answers from baseline to 6 months. Change was calculated by subtracting the number of "yes" answers at 6 months from the number of "yes" answers at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in Number of Falls at 3 Months | This is an open-ended questionnaire to see the change in number of times a person falls between time points. Change in value calculated by subtracting value at 3 months from value at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in Number of Falls at 6 Months | This is an open-ended questionnaire to see the change in number of times a person falls between time points. Change in value calculated by subtracting value at 6 months from value at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in 3-day Diet Record, Calories, at 3 Months | 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in calories calculated by subtracting average daily calories at 3 months from average daily calories at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in 3-day Diet Record, Calories, at 6 Months | 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in calories calculated by subtracting average daily calories at 6 months from average daily calories at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Change in 3-day Diet Record, Protein, at 3 Months | 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in protein in grams calculated by subtracting average daily protein in grams at 3 months from average daily protein in grams at baseline. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Change in 3-day Diet Record, Protein, at 6 Months | 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in protein in grams calculated by subtracting average daily protein in grams at 6 months from average daily protein in grams at baseline. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| Secondary | Number of Participants Measured Using an Axis Accelerometer (Actigraph) | Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at baseline. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Number of Participants Measured Using an Axis Accelerometer (Actigraph) | Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at 3 months. | A small number of participants do not have this measurement due to Covid-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Number of Participants Measured Using an Axis Accelerometer (Actigraph) | Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at 6 months. | A small number of participants do not have this measurement due to Covid-19 disruptions to clinical research, missed appointments, or participant withdrawals/dropouts. Additionally, some study participants were enrolled for a 3 month, rather than a 6 month, intervention period, thus they have no measurements at 6 months. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Change in Glucose Tolerance Test (OGTT) (78-80), Blood | Ingestion of a 75 g glucose load | These data were unable to be collected due to methodologic difficulties and logistical constraints. | Posted | 3 months |
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| Secondary | Change in Glucose Tolerance Test (OGTT) (78-80), Blood | Ingestion of a 75 g glucose load | These data were unable to be collected due to methodologic difficulties and logistical constraints. | Posted | 6 months |
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| Secondary | Percent Attendance at Weekly Diet Class Between Baseline and 3 Months | Attendance counted if in person or virtual. Percentage calculated by dividing number of classes attended by number of classes held and multiplying by 100. | Not Posted | Mar 2026 | Baseline and 3 months | Participants |
| Secondary | Percent Attendance at Weekly Diet Class Between Baseline and 6 Months | Attendance counted if in person or virtual. Percentage calculated by dividing number of classes attended by number of classes held and multiplying by 100. | Not Posted | Mar 2026 | Baseline and 6 months | Participants |
| 0 |
| 32 |
| 0 |
| 32 |
| 10 |
| 32 |
| EG001 | WL-Protein | >30 g of high quality protein per meal, 1.4 g protein/kg body weight/day. 21 servings of high quality (30 g/serving) protein (lean meats, whey protein powder, protein drinks) provided to participants each week to increase compliance. Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). | 1 | 32 | 1 | 32 | 13 | 32 |
| EG002 | Consented, Not Randomized | Participants who consented but were never randomized due to participant withdrawal or not qualifying. | 0 | 41 | 0 | 41 | 2 | 41 |
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| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Surgery | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Removal of melanoma |
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| Broken bone | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Spinal stenosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Spinal Stenosis | Surgical and medical procedures | Non-systematic Assessment |
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| Complications from Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pre-existing condition |
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| Frequent Urination | Renal and urinary disorders | Non-systematic Assessment |
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| Respiratory Illness | Infections and infestations | Non-systematic Assessment |
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| Dizziness, nausea, abdominal pain | General disorders | Non-systematic Assessment |
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| Shoulder pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Adrenal gland removal | Surgical and medical procedures | Non-systematic Assessment |
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| Shoulder surgery | Surgical and medical procedures | Non-systematic Assessment | Due to prior injury |
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| Eye pain | Eye disorders | Non-systematic Assessment | Due to past injury. |
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| Leg pain/weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Attributed to arthritis |
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| Elevated blood pressure | Vascular disorders | Non-systematic Assessment |
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| ED visit for difficulty breathing/coughing blood possibly related to congestive heart failure | General disorders | Non-systematic Assessment |
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| Shingles | Infections and infestations | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Bursitis in elbow | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Blood clot in eye | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Gluteal cleft abscess | Infections and infestations | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |