<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03835416</url>
  </required_header>
  <id_info>
    <org_study_id>E2843-R</org_study_id>
    <nct_id>NCT03835416</nct_id>
  </id_info>
  <brief_title>Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein</brief_title>
  <acronym>VALOR-UP</acronym>
  <official_title>Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes is a major health concern in obese older Veterans, especially in those who are&#xD;
      African American. The negative impact of diabetes on muscle and physical function contributes&#xD;
      to metabolic as well as physical decline and is under-studied. This randomized controlled&#xD;
      trial compares a higher-protein, weight loss regimen previously shown to improve physical&#xD;
      function to an Recommended Dietary Allowance (RDA) protein intervention in obese older male&#xD;
      Veterans with pre-diabetes and functional limitations. Equal numbers of white and black male&#xD;
      Veterans will be studied, filling gaps in the investigators' knowledge of differential&#xD;
      responses by race as well as obesity interventions for men in general. The primary outcome is&#xD;
      functional performance by Short Physical Performance Battery and secondary measures include&#xD;
      muscle quality, insulin sensitivity, lean body mass, physical activity, recent falls and fear&#xD;
      of falling, instrumental activities of daily living, and quality of life measured at 0, 3 and&#xD;
      6 months. The goal of this research is to accelerate functional recovery and enhance&#xD;
      independence in obese male Veterans, which is strongly aligned with the RR&amp;D mission to&#xD;
      &quot;maximize the physical and social autonomy of Veterans&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study examines an evidence-based obesity intervention as a means of reducing the impact&#xD;
      of prediabetes on muscle function in obese older men of white and black race. A total of 168&#xD;
      obese (BMI 30 kg/m2) male Veterans aged 55 + yrs, with mild to moderate functional&#xD;
      impairments (Short Physical Performance Battery score of 4 to 10 units) and prediabetes, will&#xD;
      be randomized to a higher-protein weight loss treatment (HP-WL) or an RDA-level protein&#xD;
      control weight loss treatment (C-WL). All participants receive individualized calorie&#xD;
      prescriptions calculated to achieve a weight loss of ~1-2 pounds per week and attend weekly&#xD;
      group support sessions designed to enhance diet compliance with goal setting,&#xD;
      self-monitoring, stress management, and daily diet journaling. They will also attend a weekly&#xD;
      low impact, chair exercise class. HP-WL participants are provided a supply of chilled/frozen&#xD;
      high-quality protein foods (lean meats, low fat dairy products) sufficient to give 30 g high&#xD;
      quality protein for two of three meals daily to help assure diet compliance. C-WL&#xD;
      participants are provided 1 serving per day of high quality protein to avoid unintentional&#xD;
      bias. Treatment responses will be compared for the primary outcome of functional performance&#xD;
      by Short Physical Performance Battery and important secondary measures, including muscle&#xD;
      quality, insulin sensitivity, lean body mass, physical activity, recent falls and fear of&#xD;
      falling, instrumental activities of daily living, and quality of life at 0, 3 and 6 months.&#xD;
      An exploratory aim examines potential mediators of racial differences in treatment responses&#xD;
      and documents the most successful intervention strategies. This will be the first randomized&#xD;
      controlled trial of a balanced, higher-protein diet during a metabolic challenge (caloric&#xD;
      restriction) in those with prediabetes and the first study to look at racial differences in&#xD;
      responses of obese older men to this regimen. Study findings will fulfill the RR&amp;D mission by&#xD;
      advancing interventions to improve physical function in older Veterans, yield novel&#xD;
      information about the impact of balanced, higher protein on muscle quality and insulin&#xD;
      sensitivity, and explore racial differences in responses to obesity interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 15, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two-armed Randomized Controlled Trial. Control group follows RDA-level (0.8 g/kg bw/d)protein weight loss diet. Protein follows higher protein (1.2 g/kg bw/d) weight loss diet with balanced protein at each meal.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Those responsible for outcomes assessment will be blinded from group treatment arm to every extent possible.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Short Physical Performance Battery (SPPB)</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>Three different Balance test-(side-by-side, semi-tandem, tandem). They hold each position for 10 seconds&#xD;
Possible Score for Balance Test: 0-4 Possible Score for whole SPPB Test 0-12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Short Physical Performance Battery (SPPB)</measure>
    <time_frame>0, 3, 6 months</time_frame>
    <description>Gait speed (4-meter timed walk)- we are measuring there normal walk speed.&#xD;
Possible Score for Gait Speed: 0-4 Possible Score for whole SPPB Test 0-12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Short Physical Performance Battery (SPPB)</measure>
    <time_frame>0, 3, 6 months</time_frame>
    <description>Lower Body Strength-5 Chair Stand as fast as they can do.&#xD;
Chair Stand- With arms across chest, stand up completely, returns to seated&#xD;
Possible Score for Chair Stands: 0-4 Possible Score for whole SPPB Test 0-12</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>Same scale, light clothing and no shoes, measured to nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 Minutes Walk Test (aerobic endurance)</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>As many walking laps as possible in six minutes between cones placed 40 meters apart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 8-ft Up and Go (agility/dynamic balance)</measure>
    <time_frame>0,3, and 6 months</time_frame>
    <description>Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 30 second chair stands (lower body strength)</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>With arms across chest, stand up completely, returns to seated as many times as possible in 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Isokinetic knee extension peak torque (muscle strength)</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>Knee extensor at 60 degrees with a dynamometer (HUMAC NORM Isokinetic Extremity System). Average peak torque for three trials will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Computerized Axial Tomography (CAT) scan</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>Cross sectional area of the thigh without contrast to determine muscle mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Isometric hand grip (upper body strength)</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>Jamar Hand Dynamometer (Sammons Preston Rolyan). Highest of three trials/hand.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Minimal Waist Circumference</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>At smallest horizontal circumference above umbilicus and below xiphoid process.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Composition: BodPod</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of falls and fear of falling</measure>
    <time_frame>0, 3, 6 months</time_frame>
    <description>In-person interview with questionnaire. This is a open ended questionnaire to see the change in number of times a person falls between time points. Yes or no response to the question, &quot;Do you have a fear of falling?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Cog</measure>
    <time_frame>Baseline</time_frame>
    <description>Screens for cognitive impairment with minimal language content, reduces cultural and educational bias. A 3-item recall component plus a Clock Drawing Test.&#xD;
The items recall component Score: 3 The Normal Clock Drawing Score: 2&#xD;
Eligible score to be in study is 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Short Form-36 (SF-36) Health Survey</measure>
    <time_frame>0, 3, 6, 9, 12 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Profile of Mood States (POMS)</measure>
    <time_frame>0, 3, 6, 9, 12 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>0, 3, 6, 9, 12 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Stress Scale (PSS)</measure>
    <time_frame>0, 3, 6, 9, 12 months</time_frame>
    <description>Stress Questionnaires The PSS assesses the degree to which situations in one's life are considered stressful (range 0-40).&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>0, 3, 6, 9, 12 months</time_frame>
    <description>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).&#xD;
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 &quot;global&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>0, 3, 6, 9, 12 months</time_frame>
    <description>Life Satisfaction Questionnaires The SWLS evaluates global life satisfaction, an important component of subjective well-being (range 5-35).&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 3-day diet record</measure>
    <time_frame>0, 3, 6, [9, 12] months</time_frame>
    <description>3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Protein Checklist Form</measure>
    <time_frame>0,1,2,3,4,5,6 months</time_frame>
    <description>RedCap analysis for protein they have consumed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Actigraph, Axis accelerometer (activity counts, step counts, physical activity intensity)</measure>
    <time_frame>0, 3, 6 months (7 days each time point)</time_frame>
    <description>Actigraph WGT3X-BT activity counts at 1-s epoch from three orthogonal axes at 30 Hz sampling frequency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Metabolic Panel (LabCorp)- A Blood Draw and testing</measure>
    <time_frame>0, 3, 6 months</time_frame>
    <description>Routine chemistries, blood testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glucose Tolerance Test (OGTT) (78-80), blood</measure>
    <time_frame>0, 3, 6 months</time_frame>
    <description>Ingestion of a 75 g glucose load with blood draws at 0, 10, 20, 30, 60, 90, 120, 150 and 180 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Daily food journal (Adherence)</measure>
    <time_frame>we will collect the daily food journal Up to 36 weeks through study completation</time_frame>
    <description>Daily food journal assessed by RD every week</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Prediabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>WL-Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL-Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&gt;30 g of high quality protein per meal, 1.2 g protein/kg body weight/day. Fourteen servings of high quality (30 g/serving) protein (lean meats, low fat dairy products) provided to participants each week to increase compliance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Foods rich in high quality protein</intervention_name>
    <description>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).</description>
    <arm_group_label>WL-Control</arm_group_label>
    <arm_group_label>WL-Protein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male Veterans&#xD;
&#xD;
          -  African American or Caucasian&#xD;
&#xD;
          -  Obese (BMI &gt; 30 kg/m2)&#xD;
&#xD;
          -  Age 55+ years&#xD;
&#xD;
          -  Pre-diabetes (confirmed fasting plasma glucose 100 and &lt;126 mg/dL) or HbA1c 5.7-6.4%&#xD;
&#xD;
          -  Short Physical Performance Battery score of 4 to 10 units&#xD;
&#xD;
          -  Age-normal renal function&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Able to record dietary intake or has a proxy who can record dietary intake&#xD;
&#xD;
          -  Willing and able to be randomized to either intervention group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of unstable or symptomatic life-threatening illness&#xD;
&#xD;
          -  Glomerular filtration rates (GFR) less than 45 mL/min&#xD;
&#xD;
               -  A GFR of 45-59 requires bi-monthly testing per the investigators' established&#xD;
                  algorithm&#xD;
&#xD;
               -  Those with a GFR &lt;45 mL/min are excluded&#xD;
&#xD;
          -  Mini Cog score of &lt;3&#xD;
&#xD;
             --Vegetarian&#xD;
&#xD;
          -  Neurological conditions causing functional impairments, including:&#xD;
&#xD;
               -  Parkinson's Disease&#xD;
&#xD;
               -  multiple sclerosis&#xD;
&#xD;
               -  permanent disability due to stroke&#xD;
&#xD;
          -  Inability to complete physical function assessment&#xD;
&#xD;
          -  History of significant weight instability&#xD;
&#xD;
          -  Contraindicated medications, including narcotic mail-outs and active substance abuse&#xD;
&#xD;
          -  Any psychiatric condition that would prevent the subject from participating in a group&#xD;
             intervention setting, including diagnosed personality disorders&#xD;
&#xD;
          -  Primary care provider disapproves participation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Connie W Bales, PhD RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Connie W Bales, PhD RD</last_name>
    <phone>(919) 286-0411</phone>
    <phone_ext>6780</phone_ext>
    <email>connie.bales@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705-3875</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Connie W Bales, PhD RD</last_name>
      <phone>919-286-0411</phone>
      <phone_ext>6780</phone_ext>
      <email>connie.bales@va.gov</email>
    </contact>
    <investigator>
      <last_name>Connie W Bales, PhD RD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>prediabetic state</keyword>
  <keyword>older person</keyword>
  <keyword>diet, reducing</keyword>
  <keyword>protein</keyword>
  <keyword>muscle function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03835416
org study id: E2843-R
nct id: NCT03835416
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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 quality, insulin sensitivity, lean body mass, physical activity, recent falls and fear
      of falling, instrumental activities of daily living, 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 RR&D 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 168
      obese (BMI 30 kg/m2) male Veterans aged 55 + yrs, with mild to moderate functional
      impairments (Short Physical Performance Battery score of 4 to 10 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
      quality, insulin sensitivity, lean body mass, physical activity, recent falls and fear of
      falling, instrumental activities of daily living, 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 will be the first randomized
      controlled trial of a balanced, higher-protein diet during a metabolic challenge (caloric
      restriction) in those with prediabetes and the first study to look at 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 quality and insulin
      sensitivity, and explore racial differences in responses to obesity interventions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-armed Randomized Controlled Trial. Control group follows RDA-level (0.8 g/kg bw/d)protein weight loss diet. Protein follows higher protein (1.2 g/kg bw/d) weight loss diet with balanced protein at each meal.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Those responsible for outcomes assessment will be blinded from group treatment arm to every extent possible.
measure: Change in Short Physical Performance Battery (SPPB)
time frame: 0, 3 and 6 months
description: Three different Balance test-(side-by-side, semi-tandem, tandem). They hold each position for 10 seconds
Possible Score for Balance Test: 0-4 Possible Score for whole SPPB Test 0-12
measure: Change in Short Physical Performance Battery (SPPB)
time frame: 0, 3, 6 months
description: Gait speed (4-meter timed walk)- we are measuring there normal walk speed.
Possible Score for Gait Speed: 0-4 Possible Score for whole SPPB Test 0-12
measure: Change in Short Physical Performance Battery (SPPB)
time frame: 0, 3, 6 months
description: Lower Body Strength-5 Chair Stand as fast as they can do.
Chair Stand- With arms across chest, stand up completely, returns to seated
Possible Score for Chair Stands: 0-4 Possible Score for whole SPPB Test 0-12
measure: Change in Body Weight
time frame: 0, 3 and 6 months
description: Same scale, light clothing and no shoes, measured to nearest 0.1 kg
measure: Change in 6 Minutes Walk Test (aerobic endurance)
time frame: 0, 3 and 6 months
description: As many walking laps as possible in six minutes between cones placed 40 meters apart
measure: Change in 8-ft Up and Go (agility/dynamic balance)
time frame: 0,3, and 6 months
description: Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated.
measure: Change in 30 second chair stands (lower body strength)
time frame: 0, 3, and 6 months
description: With arms across chest, stand up completely, returns to seated as many times as possible in 30 seconds.
measure: Change in Isokinetic knee extension peak torque (muscle strength)
time frame: 0, 3, and 6 months
description: Knee extensor at 60 degrees with a dynamometer (HUMAC NORM Isokinetic Extremity System). Average peak torque for three trials will be recorded.
measure: Change in Computerized Axial Tomography (CAT) scan
time frame: 0, 3, and 6 months
description: Cross sectional area of the thigh without contrast to determine muscle mass.
measure: Change in Isometric hand grip (upper body strength)
time frame: 0, 3, and 6 months
description: Jamar Hand Dynamometer (Sammons Preston Rolyan). Highest of three trials/hand.
measure: Change in Minimal Waist Circumference
time frame: 0, 3, and 6 months
description: At smallest horizontal circumference above umbilicus and below xiphoid process.
measure: Change in Body Composition: BodPod
time frame: 0, 3, and 6 months
description: 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.
measure: Change in number of falls and fear of falling
time frame: 0, 3, 6 months
description: In-person interview with questionnaire. This is a open ended questionnaire to see the change in number of times a person falls between time points. Yes or no response to the question, "Do you have a fear of falling?"
measure: Mini-Cog
time frame: Baseline
description: Screens for cognitive impairment with minimal language content, reduces cultural and educational bias. A 3-item recall component plus a Clock Drawing Test.
The items recall component Score: 3 The Normal Clock Drawing Score: 2
Eligible score to be in study is 3.
measure: Change in Short Form-36 (SF-36) Health Survey
time frame: 0, 3, 6, 9, 12 months
description: 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
measure: Change in Profile of Mood States (POMS)
time frame: 0, 3, 6, 9, 12 months
description: 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).
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: 0, 3, 6, 9, 12 months
description: 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).
measure: Change in Perceived Stress Scale (PSS)
time frame: 0, 3, 6, 9, 12 months
description: 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.
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
time frame: 0, 3, 6, 9, 12 months
description: 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.
measure: Change in Satisfaction with Life Scale (SWLS)
time frame: 0, 3, 6, 9, 12 months
description: 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.
measure: Change in 3-day diet record
time frame: 0, 3, 6, [9, 12] months
description: 3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research);
measure: Change in Protein Checklist Form
time frame: 0,1,2,3,4,5,6 months
description: RedCap analysis for protein they have consumed
measure: Change in Actigraph, Axis accelerometer (activity counts, step counts, physical activity intensity)
time frame: 0, 3, 6 months (7 days each time point)
description: Actigraph WGT3X-BT activity counts at 1-s epoch from three orthogonal axes at 30 Hz sampling frequency.
measure: Change in Metabolic Panel (LabCorp)- A Blood Draw and testing
time frame: 0, 3, 6 months
description: Routine chemistries, blood testing
measure: Change in Glucose Tolerance Test (OGTT) (78-80), blood
time frame: 0, 3, 6 months
description: Ingestion of a 75 g glucose load with blood draws at 0, 10, 20, 30, 60, 90, 120, 150 and 180 minutes.
measure: Change in Daily food journal (Adherence)
time frame: we will collect the daily food journal Up to 36 weeks through study completation
description: Daily food journal assessed by RD every week
arm group label: WL-Control
arm group type: Experimental
description: 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.
arm group label: WL-Protein
arm group type: Experimental
description: >30 g of high quality protein per meal, 1.2 g protein/kg body weight/day. Fourteen servings of high quality (30 g/serving) protein (lean meats, low fat dairy products) provided to participants each week to increase compliance.
intervention type: Dietary Supplement
intervention name: Foods rich in high quality protein
description: 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).
arm group label: WL-Control
arm group label: WL-Protein
criteria: 
gender: Male
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Connie W Bales, PhD RD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
last name: Connie W Bales, PhD RD
phone: (919) 286-0411
phone ext: 6780
email: connie.bales@va.gov
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: No