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出境医 / 临床实验 / MOVE UP Lifestyle Intervention for Caregivers

MOVE UP Lifestyle Intervention for Caregivers

Study Description
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
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
Actual Study Start Date : November 15, 2019
Actual Primary Completion Date : February 15, 2020
Actual Study Completion Date : February 15, 2020
Arms and Interventions
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).
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

Locations
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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
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Principal Investigator: Steven M Albert, PhD University of Pittsburgh
Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date March 9, 2020
Actual Study Start Date  ICMJE November 15, 2019
Actual Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
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 MOVE UP Lifestyle Intervention for Caregivers
Official Title  ICMJE Mobility and Vitality Lifestyle Program-Caregivers
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Group Assignment Implementation research for adapted effective intervention
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Body Weight
  • Healthy Diet
  • Physical Activity
  • Health Behavior
  • Healthy Aging
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: MOVE UP for Caregivers
12-week lifestyle intervention focusing on diet and activity
Intervention: Behavioral: MOVE UP
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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2020) 		5
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		25
Actual Study Completion Date  ICMJE February 15, 2020
Actual Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 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 NCT03967912
Other Study ID Numbers  ICMJE STUDY18110005
U48DP005001 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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: Steven M Albert, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2020

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

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