Strength Training for Obesity Prevention

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00030160
First received: February 7, 2002
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Obesity
Behavioral: Strength Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Strength Training for Obesity Prevention

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 160
Study Start Date: April 2002
Estimated Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   25 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Eligible participants will include women between the ages of 25 and 44, BMI between 25 and 35 (inclusive).

Other inclusion/exclusion criteria:

  1. Weight stable (<5% body weight change over past year)
  2. 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)
  3. Uncontrolled hypertension (systolic blood pressure over 160 and/or diastolic blood pressure over 99)
  4. No history of cancer within the past 5 years, excepting non-melanoma skin cancers
  5. Not currently or recently (past 6 months) pregnant
  6. Not planning to become pregnant during the study period
  7. Not currently or recently (past 2 months) lactating
  8. No history of physician diagnosed menstrual irregularities or significant gynecologic conditions (e.g. fibroids, endometriosis)
  9. Pre-menopausal
  10. Current non-smokers (for at least the past 2 years)
  11. 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
  12. Not planning to move away from the Twin Cities area over the next 2 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030160

Locations
United States, Minnesota
University of Minnesota, Division of Epidemiology
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00030160     History of Changes
Other Study ID Numbers: Schmitzm (completed), 1 R01 DK60743-01
Study First Received: February 7, 2002
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Obesity
Prevention
Exercise

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014