MOVE UP Lifestyle Intervention for Caregivers

Not Applicable

Completed

• Conditions: Healthy Diet; Healthy Aging; Health Behavior; Physical Activity; Body Weight
• Interventions: Behavioral: MOVE UP

• Registration Number: NCT03967912
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-30
• Study Start: 2019-11-15
• Primary Completion: 2020-02-15
• Study Completion: 2020-02-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MOVE UP for Caregivers	MOVE UP	12-week lifestyle intervention focusing on diet and activity

Primary Outcome Measures

Name	Time	Method
Body weight change from Baseline to 4 months	4 months	Number of participants with at least a 5% decrease in body weight from baseline at 4 months

Secondary Outcome Measures

Name	Time	Method
Change in objectively measured physical function from Baseline to 4 months	4 months	Observed performance measure using SPPB. Scores range from 0 (worst performance) to 12 (best performance)
Changes in caregiver burden	4 months	Self-report using Short Form Zarit Burden Interview (ZBI-12). Score range 0-48, in which higher scores indicate a greater burden.
Change in physical function from Baseline to 4 months	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	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	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.

Trial Locations

Locations (1)

University of Pittsburgh Prevention Research Center; 🇺🇸 Pittsburgh, Pennsylvania, United States