- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030160
Strength Training for Obesity Prevention
January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recent obesity prevalence increases have made obesity prevention a clear and pressing public health issue.
The average US.
woman gains about 0.5 kg per year.
Overweight women aged 25 to 44 have a higher prevalence of significant weight gains (BMI increases of > 5 kg/m2) than men or older or thinner women.
The difficulty in successfully losing weight and maintaining weight loss has resulted in recommendations from several expert panels to advise overweight and mildly obese individuals free of co-morbidities to avoid weight gains rather than to lose weight.
Physical activity is observed to decline with age while caloric intake remains stable or declines slightly.
There is strong observational evidence that physical activity could prevent or attenuate age associated fat gains.
This randomized, controlled behavioral intervention trial will test the hypothesis that regular participation in a twice weekly strength training program over 2 years, can prevent age associated body fat increases (total and abdominal fat) in 80 overweight to mildly obese premenopausal women between the ages of 25 and 44 years, compared to a 'standard care' group (n=80).
The overall aim of the study is to prevent body fat gains and to reduce health risks associated with obesity.
Treatment effects will be assessed for insulin sensitivity, blood pressure, blood lipids, muscle strength, and psychosocial predictors of strength training adherence.
The innovation of this approach rests in its simplicity and the minimal time requirement for full participation (2 exercise sessions weekly).
A preliminary study of this innovative approach resulted in 88% exercise session attendance over 12 months and maintenance of treatment effects on total body fat percentage to the end of pilot study measurements (9 months).
This supports the feasibility and potential for long term efficacy of the proposed intervention approach.
The long-term implication of success in this efficacy trial would be that this modest behavior change could prevent the fat gains and associated co-morbidities commonly observed in midlife women.
Study Overview
Detailed Description
Recent obesity prevalence increases have made obesity prevention a clear and pressing public health issue.
The average US.
woman gains about 0.5 kg per year, 60 to 80% of which can be assumed to be fat.
Overweight women aged 25 to 44 have a higher prevalence of significant weight gains (BMI increases of > 5 kg/m2) than men or older or thinner women.
Total and visceral abdominal fat gains are associated with a variety of obesity co-morbidities, including insulin resistance, hypertension, and dyslipidemia.
The difficulty in successfully losing weight and maintaining weight loss has resulted in recommendations from several expert panels to advise overweight and mildly obese individuals free of co-morbidities to avoid weight gains rather than to lose weight.
Physical activity is observed to decline with age while caloric intake remains stable or declines slightly.
There is strong observational evidence that physical activity could prevent or attenuate age associated fat gains.
This randomized, controlled behavioral intervention trial will test the hypothesis that regular participation in a twice weekly strength training program over 2 years, can prevent age associated body fat increases (total and visceral abdominal fat) in 80 overweight to mildly obese premenopausal women (BMI 25-35 kg/m2) between the ages of 25 and 44 years, compared to a 'standard care' group (n=80).
The overall aim of the study is to prevent body fat gains and to reduce health risks associated with obesity.
Treatment effects will be assessed for insulin sensitivity, blood pressure, blood lipids, muscle strength, and psychosocial predictors of strength training adherence.
The innovation of this approach rests in its simplicity and the minimal time requirement for full participation (2 exercise sessions weekly).
A preliminary study of this innovative approach resulted in 88% exercise session attendance over 12 months and maintenance of treatment effects on total body fat percentage to the end of pilot study measurements (9 months).
This supports the feasibility and potential for long term efficacy of the proposed intervention approach.
The long-term implication of success in this efficacy trial would be that this modest behavior change could prevent the fat gains and associated co-morbidities commonly observed in midlife women.
Study Type
Interventional
Enrollment
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota, Division of Epidemiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 44 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Eligible participants will include women between the ages of 25 and 44, BMI between 25 and 35 (inclusive).
Other inclusion/exclusion criteria:
- Weight stable (<5% body weight change over past year)
- No medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims (e.g. fibromyalgia, chronic fatigue syndrome, metabolic disorders, recent cardiovascular event, orthopedic limitations, any drug expected to impact body weight, psychiatric disorders requiring anti-psychotic drugs)
- Uncontrolled hypertension (systolic blood pressure over 160 and/or diastolic blood pressure over 99)
- No history of cancer within the past 5 years, excepting non-melanoma skin cancers
- Not currently or recently (past 6 months) pregnant
- Not planning to become pregnant during the study period
- Not currently or recently (past 2 months) lactating
- No history of physician diagnosed menstrual irregularities or significant gynecologic conditions (e.g. fibroids, endometriosis)
- Pre-menopausal
- Current non-smokers (for at least the past 2 years)
- Sedentary to modestly physically active (up to 3 sessions weekly of physical activity of no greater intensity than brisk walking) with no history of strength training within the past 6 months
- Not planning to move away from the Twin Cities area over the next 2 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
February 7, 2002
First Submitted That Met QC Criteria
February 7, 2002
First Posted (Estimate)
February 8, 2002
Study Record Updates
Last Update Posted (Estimate)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Schmitzm (completed)
- 1R01DK060743-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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