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

NCT01687803 | Completed

• 1 other identifier: 200614442-2
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Sedentary Lifestyle; Body Weight

Keywords

Obesity; Sedentary lifestyle; Body weight; Physical fitness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in dietary intake

  0, 6 months

• Change in body composition

  0, 3, and 6 months

• Change in Chronic Disease Risk Assessment

  0, 3 and 6 months

• Change in measures of stress

  0, 3 and 6 months

• Change in aerobic fitness

  0, 3, and 6 months

Study Arms (2)

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).

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.

Behavioral: Control

Interventions

Physical Activity BEHAVIORAL

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).

Physical Activity

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 42 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Related Links

• USDA Western Human Nutrition Research Center

MeSH Terms

Conditions

Obesity; Sedentary Behavior; Body Weight

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nancy L Keim, PhD

  USDA, ARS, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 19, 2012
• Study Start: October 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2011
• Last Updated: September 19, 2012

Record last verified: 2012-09