Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MOVE UP Lifestyle Intervention for Caregivers

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03967912
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Steven M. Albert, University of Pittsburgh

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Body Weight Healthy Diet Physical Activity Health Behavior Healthy Aging Behavioral: MOVE UP Not Applicable

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.

2. 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment Implementation research for adapted effective intervention
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mobility and Vitality Lifestyle Program-Caregivers
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MOVE UP for Caregivers
12-week lifestyle intervention focusing on diet and activity
Behavioral: MOVE UP
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).




Primary Outcome Measures :
  1. Body weight change from Baseline to 4 months [ Time Frame: 4 months ]
    Number of participants with at least a 5% decrease in body weight from baseline at 4 months


Secondary Outcome Measures :
  1. Change in objectively measured physical function from Baseline to 4 months [ Time Frame: 4 months ]
    Observed performance measure using SPPB. Scores range from 0 (worst performance) to 12 (best performance)

  2. Change in physical function from Baseline to 4 months [ Time Frame: 4 months ]
    Self-reports using CHAMPS. Score range is 0- 793, with higher scores indicating greater physical activity.

  3. Change in psychosocial measures from Baseline to 4 months [ Time Frame: 4 months ]
    Self-report using CES-D. Score range 0-60, in which higher scores suggest a greater presence of depressive symptoms.

  4. Changes in physical, mental, and social health [ Time Frame: 4 months ]
    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.

  5. Changes in caregiver burden [ Time Frame: 4 months ]
    Self-report using Short Form Zarit Burden Interview (ZBI-12). Score range 0-48, in which higher scores indicate a greater burden.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 50-75 years of age
  2. BMI >=27.0, but <45.0
  3. Able to consent for participation and data collection.
  4. Medical clearance from physician/health care provider before session 2 in program.
  5. Ability to walk with or without assistive device.
  6. Acting as a caregiver to someone with dementia, a serious illness, and/or a developmental or physical disability.

Exclusion Criteria:

  1. Past MOVE UP participant.
  2. If weight loss in the past year is >=10% body weight.
  3. Use of wheelchair; participant must be willing and able to increase physical activity.
  4. Uncontrolled diabetes mellitus (FBS > 30 & A1C > 11%); to be assessed by physician on medical release.
  5. Uncontrolled hypertension (SBP > 180/110) %); to be assessed by physician on medical release.
  6. Recent overnight hospitalization (past 6 months).
  7. Active treatment for cancer (including melanoma).
  8. Significant visual or hearing impairment.
  9. Significant cognitive disorder/relevant and significant psychiatric disorder (to be assessed on medical release).
  10. Inability to communicate in English/lack of translator.
  11. 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.
  12. Currently enrolled in a weight loss program, such as Weight Watchers.
  13. Inability or unwillingness to attend the majority of sessions.
  14. In the past year, participating in (other) ways of losing weight, such as bariatric surgery, prescription medications, or non-surgical interventions (reviewed by investigators).
  15. Unable to obtain medical clearance by session 2.
  16. Not acting as a caregiver.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967912


Contacts
Layout table for location contacts
Contact: Lori A Kieffer, BS 412.383.1306 lak103@pitt.edu
Contact: Jennifer King, BA 412-383-8630 jenking@pitt.edu

Locations
Layout table for location information
United States, Pennsylvania
University of Pittsburgh Prevention Research Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Centers for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Steven M Albert, PhD University of Pittsburgh

Publications:
Layout table for additonal information
Responsible Party: Steven M. Albert, Professor and Chair, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03967912     History of Changes
Other Study ID Numbers: STUDY18110005
U48DP005001 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Signs and Symptoms