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Mobility & Vitality Lifestyle Program (MOVE UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657239
Recruitment Status : Active, not recruiting
First Posted : January 15, 2016
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Steven M. Albert, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE November 25, 2015
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date March 28, 2019
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Short Physical Performance Battery [ Time Frame: 1 year ]
Physical function objectively measured by Short Physical Performance Battery (SPPB) which includes gait speed, grip strength and chair stands, each ranked as 0-4 and summed for a total score of 0-12 units
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02657239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Self-reported Physical Function [ Time Frame: 1 year ]
    Physical function self-reported with the MOS-SF36 - questions are assigned points for total points ranging fom 0-36
  • Weight [ Time Frame: 1 year ]
    Weight in kilograms
  • Height [ Time Frame: 1 year ]
    Height measured in meters
  • BMI [ Time Frame: 1 year ]
    Calculated from objective measurements of height and weight above as weight in Kilograms divided height in meters-squared
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobility & Vitality Lifestyle Program
Official Title  ICMJE Health Promotion and Disease Prevention Research Center
Brief Summary MOVE UP is a weight management program for adults 60-75 in community settings led by trained community health workers.
Detailed Description

MOVE UP is a weight management program designed for adults who desire to lose weight and improve their overall health.

Topics include: Overall Health, Weight management, Healthy eating, Behavior change, Physical activity

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: MOVE UP
Weight management behavioral program
Study Arms  ICMJE Experimental: MOVE UP Intervention
Subjects will participate in a healthy lifestyle weight management intervention focused on healthy eating and increasing physical activity
Intervention: Behavioral: MOVE UP
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 17, 2018)
303
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
400
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 60-75 at time of program start
  2. Self-reporting < 60 minutes per week of moderate structured physical activity
  3. BMI >= 30 but < 40 for screen. In person measurement on site will allow for 27-45 as inclusion criteria.
  4. Able to consent for participation and data collection
  5. Medical release before start of Weight Management
  6. Ability to walk with or without an assistive device
  7. Can regularly attend sessions
  8. Has not had bariatric surgery over the past year, or current use of weight loss prescription drug.

Exclusion Criteria:

  1. Uncontrolled diabetes mellitus (FBS > 300 & A1C > 11%) [to be assessed by physician on medical release]
  2. Uncontrolled hypertension (SBP > 180/110) %) [to be assessed by physician on medical release]
  3. Recent hospitalization (past 6 months)
  4. Active treatment for cancer (other than non-melanoma skin cancer)
  5. Significant visual or hearing impairment
  6. Dementia/psychiatric disorder
  7. Inability to communicate in English/lack of translator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657239
Other Study ID Numbers  ICMJE 1U48DP005001-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Steven M. Albert, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Anne B. Newman, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP