Enhancing Physical Function in the Long-term for Older Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Weight Loss Maintenance

Intervention / Treatment
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* Behavioral: Legacy Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Legacy Intervention<br>Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention. | Behavioral: Legacy Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | Completion of at least 85% of tele-nutrition and tele-exercise intervention | 12 week endpoint | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |