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

Obesity Clinical Trial

— FL52  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687803
• Other study ID #: 200614442-2
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: September 13, 2012
• Start date: October 2006
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 vigorous intensity physical activity on most days of the week.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years to 52 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Sedentary Lifestyle

Intervention

Behavioral:
• Physical Activity
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).
• Control
The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0, 3 and 6 months	No
Secondary	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.	0, 6 months	No
Secondary	Change in body composition	Body Composition is measured by dual energy x-ray absorptiometry (DEXA) using a whole body scan.	0, 3, and 6 months	No
Secondary	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-a, Oxylipins and other markers of oxidative stress such as oxygen radical absorptive capacity will be analyzed in plasma samples.	0, 3 and 6 months	No
Secondary	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.	0, 3 and 6 months	No
Secondary	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.	0, 3, and 6 months	No
Secondary	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.	0, 3, and 6 months	No

External Links

•   USDA Western Human Nutrition Research Center