NCT00030160

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Apr 2002

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2002

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

February 7, 2002

Last Update Submit

January 12, 2010

Conditions

Keywords

ObesityPreventionExercise

Interventions

Eligibility Criteria

Age25 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota, Division of Epidemiology

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

February 7, 2002

First Posted

February 8, 2002

Study Start

April 1, 2002

Study Completion

July 1, 2005

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations