Enhancing Physical Function in the Long-term for Older Adults
- Conditions
- Weight Loss Maintenance
- Registration Number
- NCT04490356
- Lead Sponsor
- Duke University
- Brief Summary
The intervention being studied is a 12-week nutrition and physical activity intervention, delivered using videoconference technology by registered dietitian clinicians to maintain weight loss and functional gains in older adults who successfully completed a weight loss intervention. The "Legacy Intervention" will include cognitive behavioral strategies (e.g., goal setting, self-monitoring, and social support), and draw upon a toolbox of e-approaches, including daily and weekly text reminders, virtual exercise classes, virtual individual and group nutrition classes, and step tracking device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Participated in a weight loss intervention in the last 9 months and lost ≥ 3% body weight and improved SPPB score by ≥ 1 point or 6MWT by ≥ 50 meters
- Age ≥ 60
- Able to speak and understand spoken and written English.
- Able to record dietary intake and weight
- Presence of unstable or symptomatic life-threatening illness
- Neurological conditions causing functional impairment, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke
- Inability to complete physical function assessment
- No access to internet connection to participate in the tele-intervention
- Unable or unwilling to use provided tablet to participant in tele-intervention
- History of cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Acceptability as Measured by Participant Satisfaction 12 week endpoint Participants will asked to rate their satisfaction by answering the question "Overall, I'm glad I participated in this weight maintenance program" with the following possible responses: 1- strongly disagree , 2- disagree, 3 - neither agree nor disagree, 4- agree, and and 5 -strongly agree. Score ranges from 1- 5 with higher score indicating greater satisfaction
Proportion Retention 12 week endpoint Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants
- Secondary Outcome Measures
Name Time Method Change in Physical Performance as Measured by the Short Physical Performance Battery 0 weeks, 12 weeks Scores range from 0 to 12 with higher score indicating better performance.
Change in Stress Using the Perceived Stress Scale 0 weeks, 12 weeks Perceived Stress Scale is a 10-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) 0 weeks, 12 weeks Score ranges from 0-60 with higher scores indicating greater depression symptoms.
Change in Physical Function as Measured Using the 6 Minute Walk Test 0 weeks, 12 weeks Change in distance walked in six minutes from baseline
Change in Body Weight as Measured by the Aria Fitbit Scale 0 weeks, 12 weeks Body weight in pounds.
Change in Average Weekly Steps Measured Using Garmin Watch 0 weeks, 12 weeks Average step counts using Garmin watch.
Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days) 0 weeks,12 weeks Average total calories consumed.
Change in Mood Using the Profile of Mood States Questionnaire 0 weeks, 12 weeks Change in mood from baseline, 6 and 12 weeks. Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".
Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale 0 weeks, 12 weeks Physical functioning scale of the SF-36 is a 10-items scale with a scores ranging from 0-100% where the higher score indicates greater physical functioning.
Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale 0 weeks, 12 weeks Role limitations due to physical health scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to physical health
Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale 0 weeks, 12 weeks Role limitations due to emotional problems scale of the SF-36 is a 3-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to emotional health
Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale 0 weeks, 12 weeks Energy/fatigue scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less energy/fatigue
Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale 0 weeks, 12 weeks Emotional Well-Being scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater emotional well-being
Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale 0 weeks, 12 weeks Social Functioning scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates greater social functioning.
Quality of Life Using the SF-36 Questionnaire - Pain Scale 0 weeks, 12 weeks Pain scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates less pain.
Quality of Life Using the SF-36 Questionnaire - General Health Scale 0 weeks, 12 weeks General Health scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater general health
Trial Locations
- Locations (1)
Duke University, School of Medicine
🇺🇸Durham, North Carolina, United States
Duke University, School of Medicine🇺🇸Durham, North Carolina, United States