MOVE UP Lifestyle Intervention for Caregivers
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|ClinicalTrials.gov Identifier: NCT03967912|
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Body Weight Healthy Diet Physical Activity Health Behavior Healthy Aging||Behavioral: MOVE UP||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment Implementation research for adapted effective intervention|
|Masking:||None (Open Label)|
|Official Title:||Mobility and Vitality Lifestyle Program-Caregivers|
|Estimated Study Start Date :||November 15, 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: MOVE UP for Caregivers
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 healthy eating, activity, and weight loss.behaviors. Body weight will be measured in-person session and participants will also to measure their body weight on their in Session 3, participants are given 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).
- 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
- 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)
- Change in 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.
- 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.
- Changes in physical, mental, and social health [ Time Frame: 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.
- Changes in caregiver burden [ Time Frame: 4 months ]Self-report using Short Form Zarit Burden Interview (ZBI-12). Score range 0-48, in which higher scores indicate a greater burden.
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): NCT03967912
|Contact: Lori A Kieffer, BSemail@example.com|
|Contact: Jennifer King, BAfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh Prevention Research Center|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Steven M Albert, PhD||University of Pittsburgh|