ObesityFL52NCT01687803
Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines
A study testing Physical Activity in people with Obesity and Sedentary Lifestyle, run by USDA, Western Human Nutrition Research Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 42 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sedentary Lifestyle, Body Weight
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Obesity, Sedentary Lifestyle, Body Weight
- Being tested
- Physical Activity, Control
- Keywords
- Obesity, Sedentary lifestyle, Body weight, Physical fitness
- Medical subject headings
- Obesity, Sedentary Behavior, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
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).
ControlBehavioural
The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | 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). Receives: Behavioral: Physical Activity |
| Control | Other | The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 3 and 6 months
Secondary outcomes (6)
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.
Measured: 0, 6 months
Change in body composition
Body Composition is measured by dual energy x-ray absorptiometry (DEXA) using a whole body scan.
Measured: 0, 3, and 6 months
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.
Measured: 0, 3 and 6 months
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.
Measured: 0, 3 and 6 months
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.
Measured: 0, 3, and 6 months
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.
Measured: 0, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startOct 2006
- Primary completionSep 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nancy L Keim, PhD, Principal investigator, USDA, ARS, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687803
- Sponsor's protocol ID
- 200614442-2
- Acronym
- FL52
- Status last verified
- Sep 2012
- First submitted
- 11 Sep 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines
- ClinicalTrials.gov ID
- NCT01687803
- Acronym / sponsor ID
- FL52 / 200614442-2
- Conditions
- Obesity, Sedentary Lifestyle, Body Weight
- Keywords
- Obesity, Sedentary lifestyle, Body weight, Physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Oct 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical ActivityPhysical 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). |
| Control | Other | Behavioral: ControlThe control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews. |
Who may qualify
- Ages
- 42 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityPhysical 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). | Behavioural | Physical Activity |
| ControlThe control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews. | Behavioural | Control |
Primary outcome
Change in compliance with exercise
Time frame: 0, 3 and 6 months
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.
6 secondary outcomes
Change in dietary intake
Time frame: 0, 6 months
Change in body composition
Time frame: 0, 3, and 6 months
Change in Chronic Disease Risk Assessment
Time frame: 0, 3 and 6 months
Change in measures of stress
Time frame: 0, 3 and 6 months
Change in aerobic fitness
Time frame: 0, 3, and 6 months
Change in measures of muscle strength
Time frame: 0, 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy L Keim, PhD principal investigator
USDA, ARS, Western Human Nutrition Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Obesity and Sedentary Lifestyle, run by USDA, Western Human Nutrition Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in compliance with exercise (time frame: 0, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.