Clinical trial NCT04490356: Enhancing Physical Function in the Long-term for Older Adults
Official title: Extending Legacy Benefits of Obesity Reduction in Older Adults: A Novel Telehealth Intervention Using Nutrition and Exercise
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Weight Loss Maintenance
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Retention
timeFrame: 12 week endpoint
measure: Acceptability as measured by Participant Satisfaction
timeFrame: 12 week endpoint
Secondary outcomes:
measure: Change in physical performance as measured by the Short Physical Performance Battery
timeFrame: 0, 6, 12 weeks
measure: Change in physical function as measured using the 6 minute walk test
timeFrame: 0, 6, 12 weeks
measure: Change in body weight as measured by the Aria Fitbit Scale
timeFrame: 0, 6, 12 weeks
measure: Change in Body mass as measured by the Aria Fitbit Scale (%)
timeFrame: 0, 6, 12 weeks
measure: Change in average weekly steps measured using Garmin watch
timeFrame: Every week for 12 weeks
measure: Change in total calories using 3-day food record (participants record everything they eat and drink for three days
timeFrame: 0, 6, 12 weeks
measure: Change in macronutrients using 3-day food record (participants record everything they eat and drink for three days
timeFrame: 0, 6, 12 weeks
measure: Change in Stress using the Perceived Stress Scale
timeFrame: 0, 6, 12 weeks
measure: Change in Self-reported Depression using the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 0, 6, 12 weeks
measure: Change in Mood using the Profile of Mood States questionnaire
timeFrame: 0, 6, 12 weeks
measure: Change in quality of life using the SF-36 questionnaire
timeFrame: 0, 6, 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University, School of Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Kathryn Starr, PhD
role: PRINCIPAL_INVESTIGATOR
References: