Sustainability of MOVE UP Lifestyle Intervention (MOVEUP-S)
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|ClinicalTrials.gov Identifier: NCT03963830|
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Body Weight Diet, Healthy Physical Disability||Behavioral: MOVE UP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Implementation research for adapted effective intervention|
|Masking:||None (Open Label)|
|Official Title:||Mobility and Vitality Lifestyle Program-Sustainability|
|Actual Study Start Date :||June 19, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
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).
- 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 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.
- 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.
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): NCT03963830
|Contact: Lori Kieffer, BSemail@example.com|
|Contact: Jen King, BAfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh Prevention Research Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Jen King, BA 412-383-1303 email@example.com|
|Contact: Lori Kieffer, BS 412-383-1303 firstname.lastname@example.org|
|Principal Investigator:||Steven M Albert, PhD||University of Pittsburgh|