Enhancing Exercise Participation in Overweight Adults

Tracking Information
First Submitted Date ICMJE	September 12, 2005
First Posted Date ICMJE	September 15, 2005
Last Update Posted Date	September 15, 2005
Study Start Date ICMJE	September 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 12, 2005)	body weight
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: September 12, 2005)	Fitness; physical activity; dietary intake; mediators
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Enhancing Exercise Participation in Overweight Adults
Official Title ICMJE	Enhancing Exercise Participation in Overweight Adults
Brief Summary	The purpose of this study is to examine whether behavioral strategies implemented during the adoption versus the maintenance periods of weight loss to enhance exercise participation in overweight adults are more effective than a standard behavioral intervention.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Weight Loss
Intervention ICMJE	Behavioral: behavioral weight loss
Study Arms	Not Provided
Publications *	Jakicic JM, Rickman AD, Lang W, Davis KK, Gibbs BB, Neiberg R, Marcus MD. Time-based physical activity interventions for weight loss: a randomized trial. Med Sci Sports Exerc. 2015 May;47(5):1061-9. doi: 10.1249/MSS.0000000000000482.; Janney CA, Jakicic JM. The influence of exercise and BMI on injuries and illnesses in overweight and obese individuals: a randomized control trial. Int J Behav Nutr Phys Act. 2010 Jan 6;7:1. doi: 10.1186/1479-5868-7-1.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: September 12, 2005)	225
Original Enrollment ICMJE	Same as current
Study Completion Date	May 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Female or Male; 18-55 years of age; BMI = 25-39.9 kg/m2; Ability to provide informed consent.; Ability to provide consent from their personal physician to participate in this study. Exclusion Criteria: Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.); Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.; Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 18 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects); Non-medicated resting systolic blood pressure >160 mmHg or non-medicated resting diastolic blood pressure >100 mmHg, or taking medication that would affect blood pressure.; Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).; Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.; History of myocardial infarction or valvular disease.; Weight loss of >5% of body weight within the previous 12 months.; History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00177476
Other Study ID Numbers ICMJE	1R01HL067826-01A2( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	University of Pittsburgh
Collaborators ICMJE	National Institutes of Health (NIH)
Investigators ICMJE	Principal Investigator: John M. Jakicic, Ph.D. University of Pittsburgh
PRS Account	University of Pittsburgh
Verification Date	September 2005
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP