<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/NCT01687803</url>
  </required_header>
  <id_info>
    <org_study_id>200614442-2</org_study_id>
    <nct_id>NCT01687803</nct_id>
  </id_info>
  <brief_title>Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines</brief_title>
  <acronym>FL52</acronym>
  <official_title>Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA, Western Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA, Western Human Nutrition Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this study is to determine the health benefits associated with the 2005&#xD;
      Dietary Guidelines physical activity prescription in healthy, peri-menopausal women. The 2005&#xD;
      Dietary Guidelines specifically state that to avoid unhealthy weight gain, adults should&#xD;
      participate in 60 minutes of moderate to vigorous intensity physical activity on most days of&#xD;
      the week.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a randomized controlled trial conducted over a 6 to 7 month period.&#xD;
      Subjects will be enrolled by cohorts and randomly assigned to one of two groups.&#xD;
&#xD;
        -  Group 1 (PA): physical activity intervention that will consist of brisk walking or other&#xD;
           aerobic-type activities (6 days per week), resistance exercise (using free weights,&#xD;
           resistance bands or weight stacks for weight lifting, 3 days per week), and 'active&#xD;
           lifestyle' activities such as gardening, dancing, participation in sporting activities.&#xD;
           The total time spent in these activities will add up to ~60 min/day for 6 days/week&#xD;
           (~360 minutes per week).&#xD;
&#xD;
        -  Group 2 (CON): control group will maintain their usual level of physical activity and&#xD;
           participate in testing protocols, record keeping, and interviews on the same schedule as&#xD;
           PA. This group will be offered an opportunity to have a gym membership/access to the&#xD;
           training facility after completion of the 6-month period of serving as controls.&#xD;
&#xD;
      The specific aims of this pilot study are to:&#xD;
&#xD;
        -  Assess each participant's level of compliance/adherence&#xD;
&#xD;
        -  Assess the dietary habits of study participants as they become more physically active.&#xD;
&#xD;
        -  Identify barriers to physical activity in this specific population.&#xD;
&#xD;
        -  Measure changes in body composition, physical fitness and energy expenditure.&#xD;
&#xD;
        -  Evaluate changes in chronic disease risk factors.&#xD;
&#xD;
        -  Determine if regular physical activity reduces chronic stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2006</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2009</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in compliance with exercise</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>The Actiheart (MiniMitter, Bend OR) physical activity and heart rate logger is a motion sensor and heart rate monitor worn by subjects 24 hours per day(excluding bathing and swimming) for one week to determine the level of physical activity. Subjects will also use a pedometer to record the number of steps taken during their walking sessions. The Stanford 7 day Physical Activity recall questionnaire will also be used to assess physical activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dietary intake</measure>
    <time_frame>0, 6 months</time_frame>
    <description>The 24-hour dietary recall will be used to assess usual dietary intake. Four recalls will be collected on non-consecutive days during the first and sixth months of the study. Additionally, the Healthy Eating Index for diet quality will be used to score the diets of subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>Body Composition is measured by dual energy x-ray absorptiometry (DEXA) using a whole body scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Chronic Disease Risk Assessment</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>Chronic Disease Risk Assessment includes blood pressure, fasting blood cholesterol, HDL cholesterol, LDL cholesterol, triacylglycerides, non-esterified fatty acids, ApoAI, ApoAII, and ApoB, glucose, insulin. Insulin sensitivity will be assessed by the homeostatic model utilizing fasting insulin and glucose values (fasting plasma insulin (mU/ml) X fasting plasma glucose (mmol/L)/22.5). High sensitivity C-Reactive Protein, inflammatory cytokines including IL-6 and TNF-α, Oxylipins and other markers of oxidative stress such as oxygen radical absorptive capacity will be analyzed in plasma samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in measures of stress</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>At baseline and after three and six months of the exercise intervention participants will be asked to collect saliva samples for the assessment of salivary cortisol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in aerobic fitness</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>Maximal aerobic capacity is measured using a walking graded treadmill test. Indirect calorimetry will be used to measure oxygen consumption and carbon dioxide production continuously during the exercise test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in measures of muscle strength</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>Peak strength and muscle endurance of the musculature of the knee and shoulder will be measured using an isokinetic dynamometer. A measure of the maximum weight that can be moved for a single repetition (1-RM) will be measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Obesity</condition>
  <condition>Sedentary Lifestyle</condition>
  <condition>Body Weight</condition>
  <arm_group>
    <arm_group_label>Physical Activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical activity intervention will consist of brisk walking or other aerobic-type activities (6 days per week), resistance exercise (using free weights, resistance bands or weight stacks for weight lifting, 3 days per week), and 'active lifestyle' activities such as gardening, dancing, participation in sporting activities. The total time spent in these activities will add up to ~60 min/day for 6 days/week (~360 minutes per week).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity</intervention_name>
    <description>Physical activity intervention that will consist of brisk walking or other aerobic-type activities (6 days per week), resistance exercise (using free weights, resistance bands or weight stacks for weight lifting, 3 days per week), and 'active lifestyle' activities such as gardening, dancing, participation in sporting activities. The total time spent in these activities will add up to ~60 min/day for 6 days/week (~360 minutes per week).</description>
    <arm_group_label>Physical Activity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index: 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  Peri-menopause, as determined by self-report of menstrual history and symptoms for&#xD;
             previous 12 months&#xD;
&#xD;
          -  Sedentary lifestyle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are already physically active&#xD;
&#xD;
          -  Pregnant or nursing within the last 6 months&#xD;
&#xD;
          -  Plan to become pregnant during the study&#xD;
&#xD;
          -  Musculoskeletal disease or disorder which is expected to limit participation in&#xD;
             physical activity&#xD;
&#xD;
          -  Orthopedic injuries&#xD;
&#xD;
          -  Inflammatory arthritis or autoimmune disorders&#xD;
&#xD;
          -  Neuromuscular disorders including multiple sclerosis, amyotrophic lateral sclerosis,&#xD;
             Parkinson's disease&#xD;
&#xD;
          -  Menopause confirmed&#xD;
&#xD;
          -  Use of tobacco products&#xD;
&#xD;
          -  Family history of premature cardiovascular disease as defined by the ACSM guidelines&#xD;
&#xD;
          -  Cardiovascular including a history of cardiac arrest; coronary heart disease, complex&#xD;
             ventricular arrhythmia or atrial arrhythmia at rest or with exercise, congestive heart&#xD;
             failure, cardiomyopathy, hemodynamically significant valvular heart disease, left&#xD;
             bundle block, cardiac pacemaker; implanted cardiac defibrillator; history of aortic&#xD;
             aneurysm of at least 7 cm in diameter or aortic aneurysm repair; resting heart rate &lt;&#xD;
             45 beats per minute or &gt; 100 beats per minute&#xD;
&#xD;
          -  Chronic lung disease resulting in dyspnea at rest or with minimal exertion, lung&#xD;
             disease resulting in hypoxia or hypercapnia at rest or with exercise, pulmonary&#xD;
             embolus within 6 months, active tuberculosis&#xD;
&#xD;
          -  Presence of risk factors for cardiovascular or metabolic disease:&#xD;
&#xD;
          -  Hypertension (SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg); hypertension treated by beta&#xD;
             adrenergic blockers regardless of blood pressure&#xD;
&#xD;
          -  Elevated fasting LDL cholesterol (≥160 mg/dL)&#xD;
&#xD;
          -  Elevated fasting triglycerides (≥300 mg/dL)&#xD;
&#xD;
          -  Diagnosed diabetes mellitus or elevated fasting glucose (≥126 mg/dL), adrenal disease,&#xD;
             acromegaly, or thyroid disease requiring medication change or other treatment within&#xD;
             the previous 3 months&#xD;
&#xD;
          -  Weight change greater than 10 lbs in the preceding 6 months&#xD;
&#xD;
          -  Medications: chronic corticosteroid use or need for oral corticosteroids more than&#xD;
             twice in the last 12 months, antipsychotic medications, beta adrenergic blockers,&#xD;
             medications for weight loss (including sibutramine, orlistat, phentermine,&#xD;
             phendimetrazine, topiramate, zonisamide), immunosuppressants, amphetamines and other&#xD;
             stimulants, and other medications known to influence body weight&#xD;
&#xD;
          -  Travel plans that do not permit full participation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>52 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy L Keim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA, ARS, Western Human Nutrition Research Center</affiliation>
  </overall_official>
  <link>
    <url>http://www.ars.usda.gov/Main/docs.htm?docid=11240</url>
    <description>USDA Western Human Nutrition Research Center</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 13, 2012</last_update_submitted>
  <last_update_submitted_qc>September 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Sedentary lifestyle</keyword>
  <keyword>Body weight</keyword>
  <keyword>Physical fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <!-- 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/NCT01687803
org study id: 200614442-2
nct id: NCT01687803
lead sponsor: 
has dmc: No
The overall goal of this study is to determine the health benefits associated with the 2005
      Dietary Guidelines physical activity prescription in healthy, peri-menopausal women. The 2005
      Dietary Guidelines specifically state that to avoid unhealthy weight gain, adults should
      participate in 60 minutes of moderate to vigorous intensity physical activity on most days of
      the week.
This study will be a randomized controlled trial conducted over a 6 to 7 month period.
      Subjects will be enrolled by cohorts and randomly assigned to one of two groups.

        -  Group 1 (PA): physical activity intervention that will consist of brisk walking or other
           aerobic-type activities (6 days per week), resistance exercise (using free weights,
           resistance bands or weight stacks for weight lifting, 3 days per week), and 'active
           lifestyle' activities such as gardening, dancing, participation in sporting activities.
           The total time spent in these activities will add up to ~60 min/day for 6 days/week
           (~360 minutes per week).

        -  Group 2 (CON): control group will maintain their usual level of physical activity and
           participate in testing protocols, record keeping, and interviews on the same schedule as
           PA. This group will be offered an opportunity to have a gym membership/access to the
           training facility after completion of the 6-month period of serving as controls.

      The specific aims of this pilot study are to:

        -  Assess each participant's level of compliance/adherence

        -  Assess the dietary habits of study participants as they become more physically active.

        -  Identify barriers to physical activity in this specific population.

        -  Measure changes in body composition, physical fitness and energy expenditure.

        -  Evaluate changes in chronic disease risk factors.

        -  Determine if regular physical activity reduces chronic stress.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Change in compliance with exercise
time frame: 0, 3 and 6 months
description: The Actiheart (MiniMitter, Bend OR) physical activity and heart rate logger is a motion sensor and heart rate monitor worn by subjects 24 hours per day(excluding bathing and swimming) for one week to determine the level of physical activity. Subjects will also use a pedometer to record the number of steps taken during their walking sessions. The Stanford 7 day Physical Activity recall questionnaire will also be used to assess physical activity.
measure: Change in dietary intake
time frame: 0, 6 months
description: The 24-hour dietary recall will be used to assess usual dietary intake. Four recalls will be collected on non-consecutive days during the first and sixth months of the study. Additionally, the Healthy Eating Index for diet quality will be used to score the diets of subjects.
measure: Change in body composition
time frame: 0, 3, and 6 months
description: Body Composition is measured by dual energy x-ray absorptiometry (DEXA) using a whole body scan.
measure: Change in Chronic Disease Risk Assessment
time frame: 0, 3 and 6 months
description: Chronic Disease Risk Assessment includes blood pressure, fasting blood cholesterol, HDL cholesterol, LDL cholesterol, triacylglycerides, non-esterified fatty acids, ApoAI, ApoAII, and ApoB, glucose, insulin. Insulin sensitivity will be assessed by the homeostatic model utilizing fasting insulin and glucose values (fasting plasma insulin (mU/ml) X fasting plasma glucose (mmol/L)/22.5). High sensitivity C-Reactive Protein, inflammatory cytokines including IL-6 and TNF-α, Oxylipins and other markers of oxidative stress such as oxygen radical absorptive capacity will be analyzed in plasma samples.
measure: Change in measures of stress
time frame: 0, 3 and 6 months
description: At baseline and after three and six months of the exercise intervention participants will be asked to collect saliva samples for the assessment of salivary cortisol.
measure: Change in aerobic fitness
time frame: 0, 3, and 6 months
description: Maximal aerobic capacity is measured using a walking graded treadmill test. Indirect calorimetry will be used to measure oxygen consumption and carbon dioxide production continuously during the exercise test.
measure: Change in measures of muscle strength
time frame: 0, 3, and 6 months
description: Peak strength and muscle endurance of the musculature of the knee and shoulder will be measured using an isokinetic dynamometer. A measure of the maximum weight that can be moved for a single repetition (1-RM) will be measured.
arm group label: Physical Activity
arm group type: Experimental
description: Physical activity intervention will consist of brisk walking or other aerobic-type activities (6 days per week), resistance exercise (using free weights, resistance bands or weight stacks for weight lifting, 3 days per week), and 'active lifestyle' activities such as gardening, dancing, participation in sporting activities. The total time spent in these activities will add up to ~60 min/day for 6 days/week (~360 minutes per week).
arm group label: Control
arm group type: Other
description: The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.
intervention type: Behavioral
intervention name: Physical Activity
description: Physical activity intervention that will consist of brisk walking or other aerobic-type activities (6 days per week), resistance exercise (using free weights, resistance bands or weight stacks for weight lifting, 3 days per week), and 'active lifestyle' activities such as gardening, dancing, participation in sporting activities. The total time spent in these activities will add up to ~60 min/day for 6 days/week (~360 minutes per week).
arm group label: Physical Activity
intervention type: Behavioral
intervention name: Control
description: The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.
arm group label: Control
criteria: 
gender: Female
minimum age: 42 Years
maximum age: 52 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy L Keim, PhD
role: Principal Investigator
affiliation: USDA, ARS, Western Human Nutrition Research Center
url: http://www.ars.usda.gov/Main/docs.htm?docid=11240
description: USDA Western Human Nutrition Research Center
responsible party type: Sponsor
mesh term: Body Weight