N/A
N=14
Enhancing Physical Function in the Long-term for Older Adults
Weight Loss Maintenance
Bottom Line
View on ClinicalTrials.gov: NCT04490356 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Proportion Retention — 93 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Legacy Intervention (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion Retention |
93 | — |
| PRIMARY Acceptability as Measured by Participant Satisfaction |
4.8 | — |
| SECONDARY Change in Physical Performance as Measured by the Short Physical Performance Battery |
10.6; 11.1 | — |
| SECONDARY Change in Physical Function as Measured Using the 6 Minute Walk Test |
— | — |
| SECONDARY Change in Body Weight as Measured by the Aria Fitbit Scale |
216.1; 215.4 | — |
| SECONDARY Change in Average Weekly Steps Measured Using Garmin Watch |
6204.8; 6365.0 | — |
| SECONDARY Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days) |
1418.4; 1525.8 | — |
| SECONDARY Change in Stress Using the Perceived Stress Scale |
10.8; 9.0 | — |
| SECONDARY Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) |
11.3; 8.8 | — |
| SECONDARY Change in Mood Using the Profile of Mood States Questionnaire |
— | — |
| SECONDARY Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale |
75.0; 79.2 | — |
| SECONDARY Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale |
59.6; 75.0 | — |
| SECONDARY Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale |
66.7; 64.1 | — |
| SECONDARY Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale |
55.4; 58.1 | — |
| SECONDARY Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale |
78.1; 80.9 | — |
| SECONDARY Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale |
82.7; 83.7 | — |
| SECONDARY Quality of Life Using the SF-36 Questionnaire - Pain Scale |
68.5; 75.2 | — |
| SECONDARY Quality of Life Using the SF-36 Questionnaire - General Health Scale |
64.6; 63.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04490356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.