search
Back to results

Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines (FL52)

Primary Purpose

Obesity, Sedentary Lifestyle, Body Weight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Activity
Control
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Sedentary lifestyle, Body weight, Physical fitness

Eligibility Criteria

42 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Body Mass Index: 18.5 to 29.9 kg/m2
  • Peri-menopause, as determined by self-report of menstrual history and symptoms for previous 12 months
  • Sedentary lifestyle

Exclusion Criteria:

  • Individuals who are already physically active
  • Pregnant or nursing within the last 6 months
  • Plan to become pregnant during the study
  • Musculoskeletal disease or disorder which is expected to limit participation in physical activity
  • Orthopedic injuries
  • Inflammatory arthritis or autoimmune disorders
  • Neuromuscular disorders including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease
  • Menopause confirmed
  • Use of tobacco products
  • Family history of premature cardiovascular disease as defined by the ACSM guidelines
  • Cardiovascular including a history of cardiac arrest; coronary heart disease, complex ventricular arrhythmia or atrial arrhythmia at rest or with exercise, congestive heart failure, cardiomyopathy, hemodynamically significant valvular heart disease, left bundle block, cardiac pacemaker; implanted cardiac defibrillator; history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair; resting heart rate < 45 beats per minute or > 100 beats per minute
  • Chronic lung disease resulting in dyspnea at rest or with minimal exertion, lung disease resulting in hypoxia or hypercapnia at rest or with exercise, pulmonary embolus within 6 months, active tuberculosis
  • Presence of risk factors for cardiovascular or metabolic disease:
  • Hypertension (SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg); hypertension treated by beta adrenergic blockers regardless of blood pressure
  • Elevated fasting LDL cholesterol (≥160 mg/dL)
  • Elevated fasting triglycerides (≥300 mg/dL)
  • Diagnosed diabetes mellitus or elevated fasting glucose (≥126 mg/dL), adrenal disease, acromegaly, or thyroid disease requiring medication change or other treatment within the previous 3 months
  • Weight change greater than 10 lbs in the preceding 6 months
  • Medications: chronic corticosteroid use or need for oral corticosteroids more than twice in the last 12 months, antipsychotic medications, beta adrenergic blockers, medications for weight loss (including sibutramine, orlistat, phentermine, phendimetrazine, topiramate, zonisamide), immunosuppressants, amphetamines and other stimulants, and other medications known to influence body weight
  • Travel plans that do not permit full participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Physical Activity

    Control

    Arm 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).

    The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.

    Outcomes

    Primary Outcome Measures

    Change in compliance with exercise
    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.

    Secondary Outcome Measures

    Change in dietary intake
    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.
    Change in body composition
    Body Composition is measured by dual energy x-ray absorptiometry (DEXA) using a whole body scan.
    Change in Chronic Disease Risk Assessment
    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.
    Change in measures of stress
    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.
    Change in aerobic fitness
    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.
    Change in measures of muscle strength
    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.

    Full Information

    First Posted
    September 11, 2012
    Last Updated
    September 13, 2012
    Sponsor
    USDA, Western Human Nutrition Research Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01687803
    Brief Title
    Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines
    Acronym
    FL52
    Official Title
    Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    USDA, Western Human Nutrition Research Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Sedentary Lifestyle, Body Weight
    Keywords
    Obesity, Sedentary lifestyle, Body weight, Physical fitness

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical Activity
    Arm Type
    Experimental
    Arm 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 Title
    Control
    Arm Type
    Other
    Arm 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(s)
    Physical Activity
    Intervention 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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control
    Intervention Description
    The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.
    Primary Outcome Measure Information:
    Title
    Change in compliance with exercise
    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.
    Time Frame
    0, 3 and 6 months
    Secondary Outcome Measure Information:
    Title
    Change in dietary intake
    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.
    Time Frame
    0, 6 months
    Title
    Change in body composition
    Description
    Body Composition is measured by dual energy x-ray absorptiometry (DEXA) using a whole body scan.
    Time Frame
    0, 3, and 6 months
    Title
    Change in Chronic Disease Risk Assessment
    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.
    Time Frame
    0, 3 and 6 months
    Title
    Change in measures of stress
    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.
    Time Frame
    0, 3 and 6 months
    Title
    Change in aerobic fitness
    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.
    Time Frame
    0, 3, and 6 months
    Title
    Change in measures of muscle strength
    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.
    Time Frame
    0, 3, and 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    42 Years
    Maximum Age & Unit of Time
    52 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Body Mass Index: 18.5 to 29.9 kg/m2 Peri-menopause, as determined by self-report of menstrual history and symptoms for previous 12 months Sedentary lifestyle Exclusion Criteria: Individuals who are already physically active Pregnant or nursing within the last 6 months Plan to become pregnant during the study Musculoskeletal disease or disorder which is expected to limit participation in physical activity Orthopedic injuries Inflammatory arthritis or autoimmune disorders Neuromuscular disorders including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease Menopause confirmed Use of tobacco products Family history of premature cardiovascular disease as defined by the ACSM guidelines Cardiovascular including a history of cardiac arrest; coronary heart disease, complex ventricular arrhythmia or atrial arrhythmia at rest or with exercise, congestive heart failure, cardiomyopathy, hemodynamically significant valvular heart disease, left bundle block, cardiac pacemaker; implanted cardiac defibrillator; history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair; resting heart rate < 45 beats per minute or > 100 beats per minute Chronic lung disease resulting in dyspnea at rest or with minimal exertion, lung disease resulting in hypoxia or hypercapnia at rest or with exercise, pulmonary embolus within 6 months, active tuberculosis Presence of risk factors for cardiovascular or metabolic disease: Hypertension (SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg); hypertension treated by beta adrenergic blockers regardless of blood pressure Elevated fasting LDL cholesterol (≥160 mg/dL) Elevated fasting triglycerides (≥300 mg/dL) Diagnosed diabetes mellitus or elevated fasting glucose (≥126 mg/dL), adrenal disease, acromegaly, or thyroid disease requiring medication change or other treatment within the previous 3 months Weight change greater than 10 lbs in the preceding 6 months Medications: chronic corticosteroid use or need for oral corticosteroids more than twice in the last 12 months, antipsychotic medications, beta adrenergic blockers, medications for weight loss (including sibutramine, orlistat, phentermine, phendimetrazine, topiramate, zonisamide), immunosuppressants, amphetamines and other stimulants, and other medications known to influence body weight Travel plans that do not permit full participation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nancy L Keim, PhD
    Organizational Affiliation
    USDA, ARS, Western Human Nutrition Research Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.ars.usda.gov/Main/docs.htm?docid=11240
    Description
    USDA Western Human Nutrition Research Center

    Learn more about this trial

    Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines

    We'll reach out to this number within 24 hrs