- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657239
Mobility & Vitality Lifestyle Program (MOVE UP)
January 10, 2020 updated by: Steven M. Albert, University of Pittsburgh
Health Promotion and Disease Prevention Research Center
MOVE UP is a weight management program for adults 60-75 in community settings led by trained community health workers.
Study Overview
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
Interventional
Enrollment (Actual)
303
Phase
- Not Applicable
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
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States
- Community Sites
-
-
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
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 60-75 at time of program start
- Self-reporting < 60 minutes per week of moderate structured physical activity
- BMI >= 30 but < 40 for screen. In person measurement on site will allow for 27-45 as inclusion criteria.
- Able to consent for participation and data collection
- Medical release before start of Weight Management
- Ability to walk with or without an assistive device
- Can regularly attend sessions
- Has not had bariatric surgery over the past year, or current use of weight loss prescription drug.
Exclusion Criteria:
- Uncontrolled diabetes mellitus (FBS > 300 & A1C > 11%) [to be assessed by physician on medical release]
- Uncontrolled hypertension (SBP > 180/110) %) [to be assessed by physician on medical release]
- Recent hospitalization (past 6 months)
- Active treatment for cancer (other than non-melanoma skin cancer)
- Significant visual or hearing impairment
- Dementia/psychiatric disorder
- Inability to communicate in English/lack of translator
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MOVE UP Intervention
Subjects will participate in a healthy lifestyle weight management intervention focused on healthy eating and increasing physical activity
|
Weight management behavioral program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
|
Weight
Time Frame: 1 year
|
Weight in kilograms
|
1 year
|
|
Height
Time Frame: 1 year
|
Height measured in meters
|
1 year
|
|
BMI
Time Frame: 1 year
|
Calculated from objective measurements of height and weight above as weight in Kilograms divided height in meters-squared
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne B. Newman, MD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
May 4, 2015
Primary Completion (Actual)
July 18, 2019
Study Completion (Actual)
July 18, 2019
Study Registration Dates
First Submitted
November 25, 2015
First Submitted That Met QC Criteria
January 13, 2016
First Posted (Estimate)
January 15, 2016
Study Record Updates
Last Update Posted (Actual)
January 14, 2020
Last Update Submitted That Met QC Criteria
January 10, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1U48DP005001-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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