Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein

Not Applicable

Completed

Conditions: Obesity
Prediabetes

Registration Number: NCT03835416

Lead Sponsor: VA Office of Research and Development

Brief Summary: 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".

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 105

Inclusion Criteria

Male Veterans
African American or Caucasian
Obese (BMI > 30 kg/m2)
Age 55+ years
Pre-diabetes (confirmed fasting plasma glucose 100 and <126 mg/dL) or HbA1c 5.7-6.4%
Short Physical Performance Battery score of 4 to 11 units
Age-normal renal function
English speaking
Able to record dietary intake or has a proxy who can record dietary intake
Willing and able to be randomized to either intervention group

Exclusion Criteria

Presence of unstable or symptomatic life-threatening illness
Glomerular filtration rates (GFR) less than 45 mL/min
- A GFR of 45-59 requires bi-monthly testing per the investigators' established algorithm
- Those with a GFR <45 mL/min are excluded
Mini Cog score of <3

--Vegetarian
Neurological conditions causing functional impairments, including:
- Parkinson's Disease
- multiple sclerosis
- permanent disability due to stroke
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Short Physical Performance Battery (SPPB) Score at Baseline	0 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.
Change in Total Short Physical Performance Battery (SPPB) Score at 3 Months	Baseline and 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.
Change in Total Short Physical Performance Battery (SPPB) Score at 6 Months	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Body Weight at 3 Months	Baseline and 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.
Percent Change in Body Weight at 6 Months	Baseline and 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.
Change in 6 Minute Walk Test (Aerobic Endurance) at 3 Months	Baseline and 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.
Change in 6 Minute Walk Test (Aerobic Endurance) at 6 Months	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.
Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 3 Months	Baseline and 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.
Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 6 Months	Baseline and 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.
Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 3 Months	Baseline and 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.
Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 6 Months	Baseline and 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.
Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 3 Months	Baseline and 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.
Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 6 Months	Baseline and 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.
Change in Isometric Hand Grip (Upper Body Strength) at 3 Months	Baseline and 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.
Change in Isometric Hand Grip (Upper Body Strength) at 6 Months	Baseline and 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.
Change in Minimal Waist Circumference at 3 Months	Baseline and 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.
Change in Minimal Waist Circumference at 6 Months	Baseline and 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.
Change in 3-day Diet Record, Protein, at 3 Months	Baseline and 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.
Change in Body Composition: Percent Lean Mass at 3 Months	Baseline and 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.
Change in Body Composition: Percent Lean Mass at 6 Months	Baseline and 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.
Change in Body Composition: Percent Fat Mass at 3 Months	Baseline and 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.
Change in Body Composition: Percent Fat Mass at 6 Months	Baseline and 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.
Mini-Cog at Baseline Only	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.
Change in Computerized Axial Tomography (CAT) Scan at 3 Months	Baseline and 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.
Change in Computerized Axial Tomography (CAT) Scan at 6 Months	Baseline and 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.
Change in Short Form-36 (SF-36) Health Survey at 3 Months	Baseline and 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.
Change in Short Form-36 (SF-36) Health Survey at 6 Months	Baseline and 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.
Change in Profile of Mood States (POMS) at 3 Months	Baseline and 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.
Change in Profile of Mood States (POMS) at 6 Months	Baseline and 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.
Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 3 Months	Baseline and 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.
Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 6 Months	Baseline and 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.
Change in Perceived Stress Scale (PSS) at 3 Months	Baseline and 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.
Change in Perceived Stress Scale (PSS) at 6 Months	Baseline and 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.
Change in Pittsburgh Sleep Quality Index (PSQI) and 3 Months	Baseline 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.
Change in Pittsburgh Sleep Quality Index (PSQI) and 6 Months	Baseline 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.
Change in Satisfaction With Life Scale (SWLS) at 3 Months	Baseline and 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.
Change in Satisfaction With Life Scale (SWLS) at 6 Months	Baseline and 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.
Change in Hemoglobin A1c at 6 Months	Baseline and 6 months	Blood assay (LabCorp). Change in value calculated by subtracting value at 6 months from value at baseline.
Change in Fear of Falling at 3 Months	Baseline and 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.
Change in Fear of Falling at 6 Months	Baseline and 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.
Change in Number of Falls at 3 Months	Baseline and 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.
Change in Number of Falls at 6 Months	Baseline and 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.
Change in 3-day Diet Record, Calories, at 3 Months	Baseline and 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.
Change in 3-day Diet Record, Calories, at 6 Months	Baseline and 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.
Change in 3-day Diet Record, Protein, at 6 Months	Baseline and 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.
Number of Participants Measured Using an Axis Accelerometer (Actigraph)	6 months	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.
Change in Glucose Tolerance Test (OGTT) (78-80), Blood	6 months	Ingestion of a 75 g glucose load
Percent Attendance at Weekly Diet Class Between Baseline and 3 Months	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.
Percent Attendance at Weekly Diet Class Between Baseline and 6 Months	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.
Change in Hemoglobin A1c at 3 Months	Baseline and 3 months	Blood assay (LabCorp). Change in value calculated by subtracting value at 3 months from value at baseline.

Trial Locations

Locations (1): Durham VA Medical Center, Durham, NC
🇺🇸
Durham, North Carolina, United States
Durham VA Medical Center, Durham, NC
🇺🇸Durham, North Carolina, United States