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Sustainability of MOVE UP Lifestyle Intervention (MOVEUP-S)

Primary Purpose

Body Weight, Diet, Healthy, Physical Disability

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOVE UP
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pittsburgh Prevention Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MOVE UP-Sustainability

Arm Description

12-week lifestyle intervention focusing on diet and activity

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Change in objectively measured physical function from Baseline to 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
Self-report using CES-D. Score range 0-60, in which higher scores suggest a greater presence of depressive symptoms.

Full Information

First Posted
May 21, 2019
Last Updated
November 19, 2021
Sponsor
University of Pittsburgh
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03963830
Brief Title
Sustainability of MOVE UP Lifestyle Intervention
Acronym
MOVEUP-S
Official Title
Mobility and Vitality Lifestyle Program-Sustainability
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Diet, Healthy, Physical Disability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Implementation research for adapted effective intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOVE UP-Sustainability
Arm Type
Experimental
Arm Description
12-week lifestyle intervention focusing on diet and activity
Intervention Type
Behavioral
Intervention Name(s)
MOVE UP
Intervention Description
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 Measure Information:
Title
Body weight change from Baseline to 4 months
Description
Number of participants with at least a 5% decrease in body weight from baseline at 4 months
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in objectively measured physical function from Baseline to 4 months
Description
Observed performance measure using SPPB. Scores range from 0 (worst performance) to 12 (best performance)
Time Frame
4 months
Title
Change in objectively measured physical function from Baseline to 4 months
Description
Self-reports using CHAMPS. Score range is 0- 793, with higher scores indicating greater physical activity.
Time Frame
4 months
Title
Change in psychosocial measures from Baseline to 4 months
Description
Self-report using CES-D. Score range 0-60, in which higher scores suggest a greater presence of depressive symptoms.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60-75 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. Exclusion Criteria: 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M Albert, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Prevention Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30480135
Citation
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.
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