ObesityMOVE UPNCT02657239
Mobility & Vitality Lifestyle Program
A study testing MOVE UP in people with Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
MOVE UP is a weight management program for adults 60-75 in community settings led by trained community health workers. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MOVE UP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2015to 18 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity
- Being tested
- MOVE UP
- Keywords
- Physical Function
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVE UPBehavioural
Weight management behavioral program
| Study group | Role | What they receive |
|---|---|---|
| MOVE UP Intervention | Experimental | Subjects will participate in a healthy lifestyle weight management intervention focused on healthy eating and increasing physical activity Receives: Behavioral: MOVE UP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
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
Measured: 1 year
Secondary outcomes (4)
Self-reported Physical Function
Physical function self-reported with the MOS-SF36 - questions are assigned points for total points ranging fom 0-36
Measured: 1 year
Weight
Weight in kilograms
Measured: 1 year
Height
Height measured in meters
Measured: 1 year
BMI
Calculated from objective measurements of height and weight above as weight in Kilograms divided height in meters-squared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start4 May 2015
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Steven M. Albert, University of Pittsburgh
- Investigators
- Anne B. Newman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657239
- Sponsor's protocol ID
- 1U48DP005001-01
- Acronym
- MOVE UP
- Status last verified
- Jan 2020
- First submitted
- 25 Nov 2015
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Liu X, King J, Boak B, Danielson ME, Boudreau RM, Newman AB, Venditti EM, Albert SM. Effectiveness of a behavioral lifestyle intervention on weight management and mobility improvement in older informal caregivers: a secondary data analysis. BMC Geriatr. 2022 Jul 28;22(1):626. doi: 10.1186/s12877-022-03315-w.
PubMed 35902809
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion and Disease Prevention Research Center
- ClinicalTrials.gov ID
- NCT02657239
- Acronym / sponsor ID
- MOVE UP / 1U48DP005001-01
- Conditions
- Obesity
- Keywords
- Physical Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 4 May 2015 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOVE UP Intervention | Experimental | Behavioral: MOVE UPSubjects will participate in a healthy lifestyle weight management intervention focused on healthy eating and increasing physical activity |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOVE UPWeight management behavioral program | Behavioural | MOVE UP Intervention |
Primary outcome
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
4 secondary outcomes
Self-reported Physical Function
Time frame: 1 year
Weight
Time frame: 1 year
Height
Time frame: 1 year
BMI
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 35902809Liu X, King J, Boak B, Danielson ME, Boudreau RM, Newman AB, Venditti EM, Albert SM. Effectiveness of a behavioral lifestyle intervention on weight management and mobility improvement in older informal caregivers: a secondary data analysis. BMC Geriatr. 2022 Jul 28;22(1):626. doi: 10.1186/s12877-022-03315-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne B. Newman, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVE UP in people with Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.