Clinical trial NCT03967912: MOVE UP Lifestyle Intervention for Caregivers
Official title: Mobility and Vitality Lifestyle Program-Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Healthy Diet
Physical Activity
Health Behavior
Healthy Aging
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2019-05-30
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment Implementation research for adapted effective intervention
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Body weight change from Baseline to 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Change in objectively measured physical function from Baseline to 4 months
timeFrame: 4 months
measure: Change in physical function from Baseline to 4 months
timeFrame: 4 months
measure: Change in psychosocial measures from Baseline to 4 months
timeFrame: 4 months
measure: Changes in physical, mental, and social health
timeFrame: 4 months
measure: Changes in caregiver burden
timeFrame: 4 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Prevention Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven M Albert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.