Sustainability of MOVE UP Lifestyle Intervention (MOVEUP-S)

• ClinicalTrials.gov Identifier: NCT03963830
• Recruitment Status: Completed
• First Posted: May 28, 2019
• Last Update Posted: December 2, 2021
• Sponsor: University of Pittsburgh
• Collaborator: Centers for Disease Control and Prevention
• Information provided by (Responsible Party): Steven M. Albert, University of Pittsburgh

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: October 30, 2019
• Actual Study Completion Date: December 30, 2019

Arms and Interventions

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).

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 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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Steven M Albert, PhD; University of Pittsburgh

  Study Documents (Full-Text)

Documents provided by Steven M. Albert, University of Pittsburgh:

Informed Consent Form  [PDF] June 19, 2019

More Information

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.

• Responsible Party: Steven M. Albert, Professor and Chair, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03963830
• Other Study ID Numbers: Study19010159; U48DP005001 ( U.S. NIH Grant/Contract )
• First Posted: May 28, 2019
• Last Update Posted: December 2, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Body Weight