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Body WeightNCT03967912

MOVE UP Lifestyle Intervention for Caregivers

A study testing MOVE UP in people with Body Weight and Healthy Diet, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In prior research the Mobility and Vitality Lifestyle Program for healthy aging and weight management (MOVE UP) was effective in producing a mean loss of >= 5% body weight, with increased physical activity and reduced fatigue. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Body Weight, Healthy Diet, Physical Activity
What is being tested?
MOVE UP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
15 Nov 2019to 15 Feb 2020
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 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 50-75 years of age
  • BMI >=27.0, but <45.0
  • Able to consent for participation and data collection.
  • Medical clearance from physician/health care provider before session 2 in program.
  • Ability to walk with or without assistive device.
  • Acting as a caregiver to someone with dementia, a serious illness, and/or a developmental or physical disability.

Who cannot join

  • Past MOVE UP participant.
  • If weight loss in the past year is >=10% body weight.
  • Use of wheelchair; participant must be willing and able to increase physical activity.
  • Uncontrolled diabetes mellitus (FBS > 30 \& A1C > 11%); to be assessed by physician on medical release.
  • Uncontrolled hypertension (SBP > 180/110) %); to be assessed by physician on medical release.
  • Recent overnight hospitalization (past 6 months).
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  • Active treatment for cancer (including melanoma).
  • Significant visual or hearing impairment.
  • Significant cognitive disorder/relevant and significant psychiatric disorder (to be assessed on medical release).
  • Inability to communicate in English/lack of translator.
  • Currently enrolled in another research study that could impact study outcomes or interfere with either study. Exclude if less than 12 months post-graduation from previously enrolled study.
  • Currently enrolled in a weight loss program, such as Weight Watchers.
  • Inability or unwillingness to attend the majority of sessions.
  • In the past year, participating in (other) ways of losing weight, such as bariatric surgery, prescription medications, or non-surgical interventions (reviewed by investigators).
  • Unable to obtain medical clearance by session 2.
  • Not acting as a caregiver.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh Prevention Research Center

    Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

Official title: Mobility and Vitality Lifestyle Program-Caregivers

In prior research the Mobility and Vitality Lifestyle Program for healthy aging and weight management (MOVE UP) was effective in producing a mean loss of >= 5% body weight, with increased physical activity and reduced fatigue. This research will pilot a modified and streamlined version to see if it will be similarly effective for caregivers of family members or friends who have dementia, physical and/or developmental issues, or health problems.

Read the detailed description

The investigators aim to test the feasibility of delivery of a modified and streamlined lifestyle program in volunteer community settings and to provide pilot data to inform the design of future randomized controlled trials that may improve physical and mental health in older adults (50-75) who are providing care for a family member or friend who has dementia, physical and/or developmental issues, or health problems. Current objectives include:

1 . Adapt and pilot the previously studied 32-session, 13-month MOVE UP intervention to a streamlined 12-session (4-month) community-based translational behavioral weight management program. The pilot program will be delivered by a staff interventionist.

  1. Implement and evaluate the program's impact on weight and healthy lifestyle changes, including physical performance outcomes, at 2 sites, each with at least 6 eligible obese and caregiving adults ages 50-75 years old.
Being tested
MOVE UP
Medical subject headings
Body Weight, Motor Activity, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOVE UPBehavioural

    Each of the 12 group sessions will focus on incremental behavioral strategies for maintaining healthy eating, activity, and weight loss.behaviors. Body weight will be measured in-person session and participants will also to measure their body weight on their in Session 3, participants are given physical activity goal of 10 minutes/day, 50 minutes/week. The goal is raised by 5 minutes/day, 25 minutes/week every other session, the final goal being 30 minutes/day, 150 minutes/week. All subjects will be recommended to engage in an energy restricted dietary intervention that evidence demonstrates has effectively reduced body weight by 5-7% within the initial 4 months of the intervention. This will include reducing energy intake to 1200 to 1800 kcal/d based on initial body weight (<200 pounds = 1200 kcal/d; 200 to 250 pounds = 1500 kcal/d; >250 pounds = 1800 kcal/d).

Study groups in NCT03967912
Study groupRoleWhat they receive
MOVE UP for CaregiversExperimental12-week lifestyle intervention focusing on diet and activity
Receives: Behavioral: MOVE UP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight change from Baseline to 4 months

    Number of participants with at least a 5% decrease in body weight from baseline at 4 months

    Measured: 4 months

Secondary outcomes (5)

  1. Change in objectively measured physical function from Baseline to 4 months

    Observed performance measure using SPPB. Scores range from 0 (worst performance) to 12 (best performance)

    Measured: 4 months

  2. Change in physical function from Baseline to 4 months

    Self-reports using CHAMPS. Score range is 0- 793, with higher scores indicating greater physical activity.

    Measured: 4 months

  3. Change in psychosocial measures from Baseline to 4 months

    Self-report using CES-D. Score range 0-60, in which higher scores suggest a greater presence of depressive symptoms.

    Measured: 4 months

  4. Changes in physical, mental, and social health

    Self-report using PROMIS ® (Patient-Reported Outcomes Measurement Information System), which is a set of person-centered measures that evaluates physical, mental, and social health. The PROMIS-29 consists of self-report items from seven domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). Summed scores from each domain can be converted into a T-score using a table provided by test developers. The table rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A score of 50 is the average for the United States general population, and a person with a T-score of 40 is one SD below the mean. For this exploratory measure we are interested to establish effect sizes for MOVE UP, that is, how much of a change in T score is on average associated with the MOVE UP lifestyle intervention.

    Measured: 4 months

  5. Changes in caregiver burden

    Self-report using Short Form Zarit Burden Interview (ZBI-12). Score range 0-48, in which higher scores indicate a greater burden.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2019
  2. Study start15 Nov 2019
  3. Primary completion15 Feb 2020
  4. Study completion15 Feb 2020

Resources

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
Model description
Single Group Assignment Implementation research for adapted effective intervention
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03967912
Sponsor's protocol ID
STUDY18110005
Other IDs
U48DP005001
Status last verified
Nov 2021
First submitted
24 May 2019
Last updated
2 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Venditti EM, Zgibor JC, Vander Bilt J, Kieffer LA, Boudreau RM, Burke LE, Glynn NW, Jakicic JM, Smith KJ, Semler LN, Rager JR, Albert SM, Newman AB. Mobility and Vitality Lifestyle Program (MOVE UP): A Community Health Worker Intervention for Older Adults With Obesity to Improve Weight, Health, and Physical Function. Innov Aging. 2018 Jun 18;2(2):igy012. doi: 10.1093/geroni/igy012. eCollection 2018 Jun.

    PubMed 30480135

Questions about this trial

What is this clinical trial studying?

A study testing MOVE UP in people with Body Weight and Healthy Diet, 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 6 inclusion and 16 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 2 Dec 2021. 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?

Body weight change from Baseline to 4 months (time frame: 4 months). 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 NCT03967912, 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 2 Dec 2021.

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