Enhancing Physical Function in the Long-term for Older Adults

Weight Loss Maintenance Clinical Trial

Official title:

Extending Legacy Benefits of Obesity Reduction in Older Adults: A Novel Telehealth Intervention Using Nutrition and Exercise

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04490356
• Other study ID #: PRO00105630
• Secondary ID: 1P30AG064201-01
• Status: Suspended
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weight Loss
• Weight Loss Maintenance

Intervention

Behavioral:
• Legacy Intervention
The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.

Locations

Country	Name	City	State
United States	Duke University, School of Medicine	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Completion of at least 85% of tele-nutrition and tele-exercise intervention	12 week endpoint
Primary	Acceptability as measured by Participant Satisfaction	Participants will asked to rate their satisfaction using a five point likert scale (very dissatisfied; dissatisfied; neutral; satisfied; very satisfied) on a) satisfaction with the delivery of the tele-nutrition intervention, b) satisfaction with the delivery of the tele-exercise intervention c) satisfaction with their ability to maintain their physical function d) satisfaction with their ability to maintain their weight loss e) satisfaction with interactions with the registered dietitian.	12 week endpoint
Secondary	Change in physical performance as measured by the Short Physical Performance Battery	Change score of Short Physical Performance Battery score from baseline, 6 and 12 weeks	0, 6, 12 weeks
Secondary	Change in physical function as measured using the 6 minute walk test	Change score for distance walked in six minutes from baseline	0, 6, 12 weeks
Secondary	Change in body weight as measured by the Aria Fitbit Scale	Change score for body weight from baseline, 6 and 12 weeks	0, 6, 12 weeks
Secondary	Change in Body mass as measured by the Aria Fitbit Scale (%)	Change score for percent body mass from baseline, 6 and 12 weeks	0, 6, 12 weeks
Secondary	Change in average weekly steps measured using Garmin watch	Using Garmin watch to determine average weekly step count over 12 weeks study and compare change in weekly step count over time.	Every week for 12 weeks
Secondary	Change in total calories using 3-day food record (participants record everything they eat and drink for three days	Change score for total calories will be measured using 3-day food records from baseline, 6 and 12 weeks	0, 6, 12 weeks
Secondary	Change in macronutrients using 3-day food record (participants record everything they eat and drink for three days	Macronutrient intake will be measured using 3-day food records from baseline, 6 and 12 weeks	0, 6, 12 weeks
Secondary	Change in Stress using the Perceived Stress Scale	Change score for stress from baseline, 6 and 12 weeks. Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	0, 6, 12 weeks
Secondary	Change in Self-reported Depression using the Center for Epidemiologic Studies Depression Scale (CES-D)	Change score for self-reported depression from baseline, 6 and 12 weeks.	0, 6, 12 weeks
Secondary	Change in Mood using the Profile of Mood States questionnaire	Change score for 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".	0, 6, 12 weeks
Secondary	Change in quality of life using the SF-36 questionnaire	Change score for the Physical and Mental composite scores from baseline 0, 6, and 12 weeks.	0, 6, 12 weeks