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Sustainability of MOVE UP Lifestyle Intervention (MOVEUP-S)

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ClinicalTrials.gov Identifier: NCT03963830
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : July 10, 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 investigators have shown that 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. The current study will pilot a modified and streamlined program to see if it will be similarly effective.

Condition or disease Intervention/treatment Phase
Body Weight Diet, Healthy Physical Disability Behavioral: MOVE UP Not Applicable

Detailed Description:

The investigators aim to test feasibility of Community Health Worker 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. The current objective is to:

  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 trained Community Health Workers (CHWs).
  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 adults ages 60-75 years old.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Implementation research for adapted effective intervention
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mobility and Vitality Lifestyle Program-Sustainability
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: MOVE UP-Sustainability
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 recommended healthy eating, activity, and weight loss behaviors. Participants will monitor body weight and weight loss behaviors. Body weight will be measured at each in-person session and participants will also be encouraged to measure their body weight on their own. Beginning in Session 3, participants are given a home 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 objectively measured 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 60-75 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.

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.

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): NCT03963830


Contacts
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Contact: Lori Kieffer, BS 412.383.1306 lak103@pitt.edu
Contact: Jen King, BA 412-383-8630 jenking@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Prevention Research Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Jen King, BA    412-383-1303    jenking@pitt.edu   
Contact: Lori Kieffer, BS    412-383-1303    lak103@pitt.edu   
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

Publications:
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Responsible Party: Steven M. Albert, Professor and Chair, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03963830     History of Changes
Other Study ID Numbers: Study19010159
U48DP005001 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms