search
Back to results

Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults

Primary Purpose

Obesity, Multiple Chronic Conditions

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prescriptive
Behavioral
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: English-speaking, community-dwelling adults ages 65-85 (unclear benefits of weight loss if >85 years) Obesity (Body mass index [BMI] ≥30kg/m^2; ≥2 chronic conditions; Documented change within 12-weeks of enrollment of a <5% weight change; Callahan Cognitive screen questionnaire score ≥3 (ability to consent); Older Americans Resources & Services ≥6 (disability); readiness to change ≥6/10; medical clearance by primary care provider. Exclusion Criteria: documented diagnosis in the electronic health record of dementia; documented diagnosis in the electronic health record of bariatric surgery in the past; untreated psychiatric, life-threatening, or terminal illness; nursing home or hospital admission in past three months advanced heart, liver, renal failure, non-skin cancer; weight loss contraindication; anti-obesity medications; elective surgery in next twelve months; recent (<1 month) Coronavirus Disease, 2019 (COVID-19) infection; current or past participation (in the past 12 months) in another weight-loss study.

Sites / Locations

  • UNC Center for Aging and Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Prescriptive

Behavioral

Responders to Prescriptive- Continue Prescriptive

Non-responders to Prescriptive- Switch to Behavioral

Non-responders to Prescriptive- Combination of Prescriptive and Behavioral

Responders to Behavioral- Continue Behavioral

Non-responders to Behavioral- Switch to Prescriptive

Non-responders to Behavioral- Combination of Prescriptive and Behavioral

Arm Description

A diet and exercise prescription individually tailored to each participant's multiple chronic health conditions will provide concrete advice with less autonomy, and will minimize risks of physiologic changes due to weight loss (hypoglycemia, hypotension, muscle loss). Licensed, trained professionals- Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will introduce clinical reasoning, knowledge, and experience, assess biological adaptations to weight loss, modify prescriptions based on changing medical needs, and provide real-time and asynchronous guidance. Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will deliver group and individual, live sessions to the home by telemedicine. Sessions will last 60-min (Registered Dietician Nutritionist: 20 min; Physical Therapy: 40 min).

Health coaches have a bachelor's degree and take a 6-8-week certification program. Health coaches will use a structured manual involving evidence-based behavior change techniques (problem-solving, self-regulation, motivation). Group and individual sessions will be via telemedicine. Conceptual model targets include: barrier identification: problem-solving to identify and address barriers to meet goals self-regulation: a focus on self-monitoring and behavior goals with feedback autonomous motivation: self-selecting goals, motivational interviewing use, and creating plans; and (d) self-efficacy: learning from group experiences, verbal persuasion, and encouraging pursuit of goals in the face of setbacks.

The prescriptive strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the prescriptive intervention. Participants will continue their diet and exercise programs that were initially tailored to them.

Participants who lost less than 2.5 percent (%) of their body weight initially will be randomized to a different type of intervention. One possibility could be that participants switch first-line treatment from a prescriptive strategy to the alternative (behavioral) as participants may need motivation or problem-solving.

Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention- three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.

The behavioral strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the behavioral intervention.

Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants switch first-line treatment strategy to the alternative (prescriptive) as participants may need knowledge to support adherence.

Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention - three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.

Outcomes

Primary Outcome Measures

Change in weight from baseline
Absolute change in weight percentage (%) over time from baseline to 52-weeks. Weight will be objectively measured on a digital scale. A negative number will indicate weight loss.

Secondary Outcome Measures

Change in Patient reported outcomes measurement information systems (PROMIS)- Global health
PROMIS (Patient Reported Outcomes Measurement Information System) gauges physical, mental, and social aspects of health (5-point scale). A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health. Range (0-100)
Change in Patient reported outcomes measurement information systems (PROMIS)- Physical function
Self-reported physical function (5-point scale) measure that is a responsive measure evaluating mobility and activities of daily living; A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health. Range (0-100)
Change in 30-second sit-to-stand from baseline
This is a construct of physical function that predicts falls and disability and is sensitive to change. The 30-second sit-to-stand test is administered using a folding chair without arms and involves recording the number of stands from a seated position a person can complete in 30 seconds. Change in 30-s sit-to-stand in repetitions over time will be reported from baseline to 78-weeks. An improvement in repetitions will represent an improvement of physical function. The continuous value correlates with quadriceps Minimal Clinically Important Difference (2.0 repetitions)
Change in grip strength from baseline
An objective measure that relates to upper and lower extremity strength, and predicts mobility disability. Using a Jamar dynamometer, change in participant's maximal grip strength measurement in kilograms from baseline. Absolute change in grip strength in kilograms over time will be reported from baseline to 78-weeks. An increase in kilograms represented on the device will represent an improvement of physical function. No cutoffs will be used for this - the research team will be use the continuous value.
Change in gait speed from baseline
Gait speed (measured in meters/second or m/s) measures how long it takes a person to travel a given distance. It is A simple, clinical measure of objective physical function that reflects health and functional status and predicts falls, disability, and mortality. Gait Speed is measured using the time in seconds it takes a participant to complete a 4 meter course while walking at a usual pace. Gait speed is measured as distance (meters) ÷ time (seconds). An absolute change in gait speed will be the difference from follow-up measures and baseline. An improvement in gait speed represents an improvement in physical function. Units are meters/second. Normal >1.2m/s.
Change in 6-minute walk from baseline
A measure of aerobic endurance (normal distance 400-700m) that is a surrogate for submaximal aerobic/cardiovascular fitness. Clinically significant change ranges between 14-30.5 m.
Change in waist circumference from baseline
Absolute change in waist circumference in centimeters (cm) over time from baseline. Waist circumference will be measured objectively using a tape measure. A negative number will indicate a loss in waist circumference
Change in hip circumference from baseline
Absolute change in hip circumference in centimeters (cm) over time from baseline. Hip circumference will be measured objectively using a tape measure. A negative number will indicate a loss of hip circumference
Proportion with greater than or equal to 5% weight loss
The proportion achieving a clinically significant 5% weight loss
Change in % body fat from baseline
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess total body fat % (percent). A reduction in the percentage of total body fat is suggestive of improvements in health related outcomes.
Change in volume of visceral fat from baseline
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess visceral fat mass % (percent). A reduction in visceral fat volume is suggestive of improvements in health related outcomes.
Change in appendicular lean mass from baseline
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess percent (%) lean mass (total, segmental). A reduction in lean mass percentage is suggestive of worsening of health related outcomes.
Late-life function and disability instrument
Self-reported 32-item physical function measure consisting of function and life-task items that correlate with gait speed and lower-limb function. A 2-point difference is clinically significant. Range, (scaled score, 0-100). Higher scores indicate better performance and less limitation than lower scores.
Change in Pittsburgh Fatigability questionnaire
The 15-item Pittsburgh Fatigability Scale measures perceived fatigue of sedentary, social, lifestyle and physical activities (light-high intensity, 0-50 scale). Cutoff of ≥15 and ≥13 indicate higher physical and mental fatigue that may lead to reduced performance or restricted activity. Higher scores indicate greater perceived physical or mental fatigability. A reduction in the absolute change in score suggests improvements in fatigue.
Change in Self-efficacy- exercise
The Self-Efficacy for Exercise Scale (range 0-90) is based on the Social Cognitive Theory (higher scores mean higher self-efficacy for initiating/maintaining exercise). A positive change in self-efficacy reflects better outcomes, and a negative change reflects worse outcomes.
Change in Self-efficacy- nutrition
The 8-item Weight-Efficacy Lifestyle Short Form measures confidence in adopting and maintaining weight loss behaviors. A 15-point change was related to a 25% weight loss in bariatric surgery participants. Range (0-80). A positive change in self-efficacy reflects better outcomes, and a negative change reflects worse outcomes.
Change in Self-efficacy- technology
A 10-item Likert scale (1-10) will measure daily Technology Self-Efficacy (higher score means higher self-efficacy). Range (0-100)
Change in Goal setting- exercise
Only conducted in the Behavioral arms. This is a Likert Scale question, where answers can range from 1-10, with higher scores indicating better goal setting abilities
Change in Goal setting- nutrition
Only conducted in the Behavioral arms. This is a Likert Scale questionnaire, where answers can range from 1-10, with higher scores indicating better goal setting abilities.
Change in Goal setting- technology
Only conducted in the Behavioral arms. This is a Likert Scale questionnaire, where answers can range from 1-10, with higher scores indicating better goal setting abilities.
Change in social support for diet
A validated scale that assesses friends/family support for engaging in dietary changes. Higher scores indicate higher social support. Each are scored for family and friends separately (range 0-100).
Change in social support for exercise
A validated scale that assesses friends/family support for engaging in dietary exercises. Higher scores indicate higher social support. Each are scored for family and friends separately (range 0-60).
Treatment self-regulation: diet
A validated 15-item, 7-point scale (range 0-100) reflecting autonomous motivation and controlled motivation. Higher scores indicate better outcomes.
Treatment self-regulation: exercise
A validated 15-item, 7-point scale (range 0-100) reflecting autonomous motivation and controlled motivation. Higher scores indicate better outcomes.
Change in caloric intake
Using the Automated Self-Administered 24-hour Dietary Assessment (ASA-24), the investigators will measure caloric intake per day. Change measured in the difference between calories per day at baseline, throughout study, and follow-up assessment. This is an automated food recall that assess caloric intake. A change in caloric intake will be reported in kcal per day. Reduction in caloric input suggests reduced calorie intake.
Physical activity: community healthy activities model program for seniors
This questionnaire, known as CHAMPS (community healthy activities model program for seniors), will assess activity levels and types (weekly caloric expenditure; frequency of activities) and their changes. The investigators will use a standardized algorithm to assess low, moderate, vigorous activity and caloric output
Patient activation measure
Patient Activation Measure assesses knowledge, skills & confidence for managing health revealing insights into motivators, behaviors, attitudes & outcomes (4 points each; score 0-100, low to high) 0, 8, 16, 26, 52, 78 weeks
Fitbit use- Wear/non-wear time
Measurement using Fitbit data of the time spent during the day wearing the device.
Fitbit use- activity/steps
Evaluation using Fitbit data of the average number of steps (and total number to that point) a participant has engaged in
Attendance
Feasibility of study procedures measured as the mean attendance rate of all participants. Participant attendance rate = (total # of visits attended / total # of visits scheduled) x 100. There are no cut-off scores for interpretation. Higher scores indicate higher feasibility
Acceptability of Study Intervention
Measured through an end of study satisfaction survey, acceptability is measured on a 10 point Likert scale conducted on all participants at 78-weeks. This is rated on a 1 (strongly disagree) to 10 (strongly agree) survey.
Percent of participants rating the intervention as acceptable
Conducted on all participants using a 1-5 Likert scale to assess appropriateness of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Acceptability is reported as Agree or Completely Agree responses. Percent is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.
Telehealth satisfaction
A end-of-study questionnaire that assesses patient satisfaction regarding the use of Telehealth (Likert scale, 1-10). Range 0-100. Higher scores indicate better outcomes.
Telehealth usability survey
A single item Likert scale (1-10) will measure usefulness, ease of use, effectiveness, reliability & satisfaction of telemedicine. This will be measured at the conclusion of the study intervention. Range 0-100. Higher scores indicate better outcomes.
Change in systolic blood pressure
The difference between baseline and follow-up values-measured in mmHg (millimeters of mercury)- a value of 5mmHg (millimeters of mercury) is clinically significant
Change in diastolic blood pressure
The difference between baseline and follow-up values (measured in mmHg)- a value of 5mmHg (millimeters of mercury) is clinically significant
Change in low density lipoprotein blood levels
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel. Levels >100mg/dL would be potentially clinically actionable. 0, 8, 52 weeks
Change in high density lipoprotein blood levels
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel
Change in total cholesterol blood levels
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel
Change in glucose blood levels
The difference between baseline and follow-up values, units in mg/dL (milligrams per deciliter). A glucose level >126mg/dL is considered diabetic.
Change in calf circumference from baseline
Change in calf circumference in centimeters (cm) over time from baseline to 12-weeks. Calf circumference will be measured objectively using a tape measure. A negative number will indicate a loss in calf circumference
Change in arm circumference from baseline
Change in arm circumference in centimeters (cm) over time from baseline to 12-weeks. Arm circumference will be measured objectively using a tape measure. A negative number will indicate a loss in arm circumference.

Full Information

First Posted
September 12, 2023
Last Updated
September 25, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT06044571
Brief Title
Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
Official Title
Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults With Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
January 31, 2028 (Anticipated)
Study Completion Date
January 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study seeks to answer the fundamental questions of which initial, first-line weight loss intervention should be offered to older adults with obesity and multiple chronic conditions and how to address the high non-response rates observed with most conventional strategies. A sequential, multiple assignment, randomized trial (SMART) design will permit the evaluation of treatment combinations that maximize weight loss and will provide data on constructing a future tailored, adaptive intervention. If successful, these findings will identify interventions that could markedly improve health and quality of life of these older adults, reduce long-term disability, and lower healthcare costs
Detailed Description
Purpose: Consistent with the research priorities of the National Institute on Aging, this research protocol will investigate the optimal intervention sequence to achieve weight loss in older adults with obesity and more than 2 chronic conditions, termed multiple chronic conditions (MCC). To this end, the specific aims are to: 1) test the superiority of an initial prescriptive or behavioral intervention using an adaptive strategy for early non-responders; 2) assess the patterns of initial weight loss and compare strategies for non-responders using an adaptive strategy; and 3) examine the cost-effectiveness from a societal perspective for maintaining weight loss of the proposed sequences at 78 weeks (26 weeks post-intervention completion). Procedures (methods): The investigators will conduct a 52-week, two-stage, Sequential, Multiple Assignment, Randomized Trial (SMART) enrolling 180 older adults with obesity and MCC to compare two weight loss interventions: 1) a prescriptively-focused, medically-tailored, weight loss intervention(prescriptive), or 2) a behaviorally-focused, health coaching intervention (behavioral). Consistent with a SMART design, at 8 weeks, the investigators will randomize early non-responders (weight loss of < 2.5%) to (a) a combination of prescriptive and behavioral interventions; or (b) switching to either a prescriptive, medically-tailored model (or vice versa). Aim 1 - Efficacy Test the superiority of an initial prescriptive vs. behavioral intervention on the differences in weight loss (primary outcome) and secondary outcomes, using an adaptive strategy for early non-responders in a 52-week, telehealth-based SMART. At 52-weeks, percent weight loss (primary outcome) will be greater among patients initially randomized to a prescriptive intervention, as will global health and physical function, anthropometry, behavioral treatment targets and risk factors, and clinical indices (secondary outcomes). Aim 2 - Precision Medicine Assess the patterns of initial weight loss and compare strategies for non-responders to weight loss (combined prescriptive and behavioral, or switching initial treatment strategies [prescriptive to behavioral, or behavioral to prescriptive]). The investigators will estimate an adaptive strategy (dynamic treatment regime) to give the right intervention to the right participant. The investigators hypothesize that this dynamic regime will lead to a better outcome, on average, compared to the best non-adaptive (fixed) regime Aim 3 - Cost-Effectiveness Examine the cost-effectiveness from a societal perspective at 78-weeks (26 weeks post-intervention completion). For the initial, first-line interventions, the investigators will estimate the incremental cost per percent weight change and assess secondary outcomes of the incremental cost for maintaining at least a 5% weight loss, and quality-adjusted life years. The investigators will also model the cost-effectiveness of the precision medicine approach predicted to have the greatest individualized likelihood of weight loss response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Multiple Chronic Conditions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A single site two-stage, Phase III clinical trial using a SMART design, will assess the superiority between two first-line strategies (prescriptive, behavioral) on percent weight loss at 52 weeks
Masking
ParticipantCare Provider
Masking Description
This trial will have a single-masked design, so the team assessing study outcomes is masked to intervention assignment. Participants will be asked not to reveal their assignment. Arm assignment cannot be blinded due to the study's design. The assessment team will schedule assessments to minimize contact with the intervention team to maintain separation. Data entry and analysis will be blinded to the study investigators, besides Kosorok and team. Assessments will be done at different times and in separate areas at the study site. The intervention setting for participants will be in their homes. To enhance continued masking, participants will be asked not to disclose their assigned group and not to discuss their intervention arms during assessment sessions. Assessment of compliance to the intervention will be performed by the intervention team and not by the outcome assessment team. The investigators will be blinded to data analysis, collection, and study arms.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prescriptive
Arm Type
Active Comparator
Arm Description
A diet and exercise prescription individually tailored to each participant's multiple chronic health conditions will provide concrete advice with less autonomy, and will minimize risks of physiologic changes due to weight loss (hypoglycemia, hypotension, muscle loss). Licensed, trained professionals- Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will introduce clinical reasoning, knowledge, and experience, assess biological adaptations to weight loss, modify prescriptions based on changing medical needs, and provide real-time and asynchronous guidance. Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will deliver group and individual, live sessions to the home by telemedicine. Sessions will last 60-min (Registered Dietician Nutritionist: 20 min; Physical Therapy: 40 min).
Arm Title
Behavioral
Arm Type
Active Comparator
Arm Description
Health coaches have a bachelor's degree and take a 6-8-week certification program. Health coaches will use a structured manual involving evidence-based behavior change techniques (problem-solving, self-regulation, motivation). Group and individual sessions will be via telemedicine. Conceptual model targets include: barrier identification: problem-solving to identify and address barriers to meet goals self-regulation: a focus on self-monitoring and behavior goals with feedback autonomous motivation: self-selecting goals, motivational interviewing use, and creating plans; and (d) self-efficacy: learning from group experiences, verbal persuasion, and encouraging pursuit of goals in the face of setbacks.
Arm Title
Responders to Prescriptive- Continue Prescriptive
Arm Type
Experimental
Arm Description
The prescriptive strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the prescriptive intervention. Participants will continue their diet and exercise programs that were initially tailored to them.
Arm Title
Non-responders to Prescriptive- Switch to Behavioral
Arm Type
Experimental
Arm Description
Participants who lost less than 2.5 percent (%) of their body weight initially will be randomized to a different type of intervention. One possibility could be that participants switch first-line treatment from a prescriptive strategy to the alternative (behavioral) as participants may need motivation or problem-solving.
Arm Title
Non-responders to Prescriptive- Combination of Prescriptive and Behavioral
Arm Type
Experimental
Arm Description
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention- three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.
Arm Title
Responders to Behavioral- Continue Behavioral
Arm Type
Experimental
Arm Description
The behavioral strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the behavioral intervention.
Arm Title
Non-responders to Behavioral- Switch to Prescriptive
Arm Type
Experimental
Arm Description
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants switch first-line treatment strategy to the alternative (prescriptive) as participants may need knowledge to support adherence.
Arm Title
Non-responders to Behavioral- Combination of Prescriptive and Behavioral
Arm Type
Experimental
Arm Description
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention - three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.
Intervention Type
Other
Intervention Name(s)
Prescriptive
Intervention Description
Prescriptive A diet and exercise prescription individually tailored to each participant's multiple chronic health conditions will provide concrete advice with less autonomy, and will minimize risks of physiologic changes due to weight loss (hypoglycemia, hypotension, muscle loss). Licensed, trained professionals, Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs), will introduce clinical reasoning, knowledge, and experience, assess biological adaptations to weight loss, modify prescriptions based on changing medical needs, and provide real-time and asynchronous guidance. Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs)will deliver group and individual, live sessions to the home by telemedicine. Sessions will last 60-min (Registered Dietician Nutritionist: 20 min; Physical Therapist: 40 min).
Intervention Type
Behavioral
Intervention Name(s)
Behavioral
Intervention Description
Behavioral Health coaches have a bachelor's degree and take a 6-8-week certification program. Behavioral Health coaches will use a structured manual involving evidence-based behavior change techniques (problem-solving, self-regulation, motivation). Group and individual sessions will be via telemedicine.
Primary Outcome Measure Information:
Title
Change in weight from baseline
Description
Absolute change in weight percentage (%) over time from baseline to 52-weeks. Weight will be objectively measured on a digital scale. A negative number will indicate weight loss.
Time Frame
8, 16, 26, 52, 78 weeks
Secondary Outcome Measure Information:
Title
Change in Patient reported outcomes measurement information systems (PROMIS)- Global health
Description
PROMIS (Patient Reported Outcomes Measurement Information System) gauges physical, mental, and social aspects of health (5-point scale). A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health. Range (0-100)
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in Patient reported outcomes measurement information systems (PROMIS)- Physical function
Description
Self-reported physical function (5-point scale) measure that is a responsive measure evaluating mobility and activities of daily living; A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health. Range (0-100)
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in 30-second sit-to-stand from baseline
Description
This is a construct of physical function that predicts falls and disability and is sensitive to change. The 30-second sit-to-stand test is administered using a folding chair without arms and involves recording the number of stands from a seated position a person can complete in 30 seconds. Change in 30-s sit-to-stand in repetitions over time will be reported from baseline to 78-weeks. An improvement in repetitions will represent an improvement of physical function. The continuous value correlates with quadriceps Minimal Clinically Important Difference (2.0 repetitions)
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in grip strength from baseline
Description
An objective measure that relates to upper and lower extremity strength, and predicts mobility disability. Using a Jamar dynamometer, change in participant's maximal grip strength measurement in kilograms from baseline. Absolute change in grip strength in kilograms over time will be reported from baseline to 78-weeks. An increase in kilograms represented on the device will represent an improvement of physical function. No cutoffs will be used for this - the research team will be use the continuous value.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in gait speed from baseline
Description
Gait speed (measured in meters/second or m/s) measures how long it takes a person to travel a given distance. It is A simple, clinical measure of objective physical function that reflects health and functional status and predicts falls, disability, and mortality. Gait Speed is measured using the time in seconds it takes a participant to complete a 4 meter course while walking at a usual pace. Gait speed is measured as distance (meters) ÷ time (seconds). An absolute change in gait speed will be the difference from follow-up measures and baseline. An improvement in gait speed represents an improvement in physical function. Units are meters/second. Normal >1.2m/s.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in 6-minute walk from baseline
Description
A measure of aerobic endurance (normal distance 400-700m) that is a surrogate for submaximal aerobic/cardiovascular fitness. Clinically significant change ranges between 14-30.5 m.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in waist circumference from baseline
Description
Absolute change in waist circumference in centimeters (cm) over time from baseline. Waist circumference will be measured objectively using a tape measure. A negative number will indicate a loss in waist circumference
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in hip circumference from baseline
Description
Absolute change in hip circumference in centimeters (cm) over time from baseline. Hip circumference will be measured objectively using a tape measure. A negative number will indicate a loss of hip circumference
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Proportion with greater than or equal to 5% weight loss
Description
The proportion achieving a clinically significant 5% weight loss
Time Frame
8, 16, 26, 52, 78 weeks
Title
Change in % body fat from baseline
Description
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess total body fat % (percent). A reduction in the percentage of total body fat is suggestive of improvements in health related outcomes.
Time Frame
0, 26, 52 weeks
Title
Change in volume of visceral fat from baseline
Description
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess visceral fat mass % (percent). A reduction in visceral fat volume is suggestive of improvements in health related outcomes.
Time Frame
0, 26, 52 weeks
Title
Change in appendicular lean mass from baseline
Description
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess percent (%) lean mass (total, segmental). A reduction in lean mass percentage is suggestive of worsening of health related outcomes.
Time Frame
0, 26, 52 weeks
Title
Late-life function and disability instrument
Description
Self-reported 32-item physical function measure consisting of function and life-task items that correlate with gait speed and lower-limb function. A 2-point difference is clinically significant. Range, (scaled score, 0-100). Higher scores indicate better performance and less limitation than lower scores.
Time Frame
0, 8, 16, 26, 52, 78
Title
Change in Pittsburgh Fatigability questionnaire
Description
The 15-item Pittsburgh Fatigability Scale measures perceived fatigue of sedentary, social, lifestyle and physical activities (light-high intensity, 0-50 scale). Cutoff of ≥15 and ≥13 indicate higher physical and mental fatigue that may lead to reduced performance or restricted activity. Higher scores indicate greater perceived physical or mental fatigability. A reduction in the absolute change in score suggests improvements in fatigue.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in Self-efficacy- exercise
Description
The Self-Efficacy for Exercise Scale (range 0-90) is based on the Social Cognitive Theory (higher scores mean higher self-efficacy for initiating/maintaining exercise). A positive change in self-efficacy reflects better outcomes, and a negative change reflects worse outcomes.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in Self-efficacy- nutrition
Description
The 8-item Weight-Efficacy Lifestyle Short Form measures confidence in adopting and maintaining weight loss behaviors. A 15-point change was related to a 25% weight loss in bariatric surgery participants. Range (0-80). A positive change in self-efficacy reflects better outcomes, and a negative change reflects worse outcomes.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in Self-efficacy- technology
Description
A 10-item Likert scale (1-10) will measure daily Technology Self-Efficacy (higher score means higher self-efficacy). Range (0-100)
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in Goal setting- exercise
Description
Only conducted in the Behavioral arms. This is a Likert Scale question, where answers can range from 1-10, with higher scores indicating better goal setting abilities
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in Goal setting- nutrition
Description
Only conducted in the Behavioral arms. This is a Likert Scale questionnaire, where answers can range from 1-10, with higher scores indicating better goal setting abilities.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in Goal setting- technology
Description
Only conducted in the Behavioral arms. This is a Likert Scale questionnaire, where answers can range from 1-10, with higher scores indicating better goal setting abilities.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in social support for diet
Description
A validated scale that assesses friends/family support for engaging in dietary changes. Higher scores indicate higher social support. Each are scored for family and friends separately (range 0-100).
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in social support for exercise
Description
A validated scale that assesses friends/family support for engaging in dietary exercises. Higher scores indicate higher social support. Each are scored for family and friends separately (range 0-60).
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Treatment self-regulation: diet
Description
A validated 15-item, 7-point scale (range 0-100) reflecting autonomous motivation and controlled motivation. Higher scores indicate better outcomes.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Treatment self-regulation: exercise
Description
A validated 15-item, 7-point scale (range 0-100) reflecting autonomous motivation and controlled motivation. Higher scores indicate better outcomes.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in caloric intake
Description
Using the Automated Self-Administered 24-hour Dietary Assessment (ASA-24), the investigators will measure caloric intake per day. Change measured in the difference between calories per day at baseline, throughout study, and follow-up assessment. This is an automated food recall that assess caloric intake. A change in caloric intake will be reported in kcal per day. Reduction in caloric input suggests reduced calorie intake.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Physical activity: community healthy activities model program for seniors
Description
This questionnaire, known as CHAMPS (community healthy activities model program for seniors), will assess activity levels and types (weekly caloric expenditure; frequency of activities) and their changes. The investigators will use a standardized algorithm to assess low, moderate, vigorous activity and caloric output
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Patient activation measure
Description
Patient Activation Measure assesses knowledge, skills & confidence for managing health revealing insights into motivators, behaviors, attitudes & outcomes (4 points each; score 0-100, low to high) 0, 8, 16, 26, 52, 78 weeks
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Fitbit use- Wear/non-wear time
Description
Measurement using Fitbit data of the time spent during the day wearing the device.
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Fitbit use- activity/steps
Description
Evaluation using Fitbit data of the average number of steps (and total number to that point) a participant has engaged in
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Attendance
Description
Feasibility of study procedures measured as the mean attendance rate of all participants. Participant attendance rate = (total # of visits attended / total # of visits scheduled) x 100. There are no cut-off scores for interpretation. Higher scores indicate higher feasibility
Time Frame
78 weeks
Title
Acceptability of Study Intervention
Description
Measured through an end of study satisfaction survey, acceptability is measured on a 10 point Likert scale conducted on all participants at 78-weeks. This is rated on a 1 (strongly disagree) to 10 (strongly agree) survey.
Time Frame
78 weeks
Title
Percent of participants rating the intervention as acceptable
Description
Conducted on all participants using a 1-5 Likert scale to assess appropriateness of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Acceptability is reported as Agree or Completely Agree responses. Percent is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.
Time Frame
78 weeks
Title
Telehealth satisfaction
Description
A end-of-study questionnaire that assesses patient satisfaction regarding the use of Telehealth (Likert scale, 1-10). Range 0-100. Higher scores indicate better outcomes.
Time Frame
52, 78 weeks
Title
Telehealth usability survey
Description
A single item Likert scale (1-10) will measure usefulness, ease of use, effectiveness, reliability & satisfaction of telemedicine. This will be measured at the conclusion of the study intervention. Range 0-100. Higher scores indicate better outcomes.
Time Frame
52 weeks
Title
Change in systolic blood pressure
Description
The difference between baseline and follow-up values-measured in mmHg (millimeters of mercury)- a value of 5mmHg (millimeters of mercury) is clinically significant
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in diastolic blood pressure
Description
The difference between baseline and follow-up values (measured in mmHg)- a value of 5mmHg (millimeters of mercury) is clinically significant
Time Frame
0, 8, 16, 26, 52, 78 weeks
Title
Change in low density lipoprotein blood levels
Description
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel. Levels >100mg/dL would be potentially clinically actionable. 0, 8, 52 weeks
Time Frame
0, 8, 52 weeks
Title
Change in high density lipoprotein blood levels
Description
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel
Time Frame
0, 8, 52 weeks
Title
Change in total cholesterol blood levels
Description
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel
Time Frame
0, 8, 52 weeks
Title
Change in glucose blood levels
Description
The difference between baseline and follow-up values, units in mg/dL (milligrams per deciliter). A glucose level >126mg/dL is considered diabetic.
Time Frame
0, 8, 52 weeks
Title
Change in calf circumference from baseline
Description
Change in calf circumference in centimeters (cm) over time from baseline to 12-weeks. Calf circumference will be measured objectively using a tape measure. A negative number will indicate a loss in calf circumference
Time Frame
8, 16, 26, 52, 78 weeks
Title
Change in arm circumference from baseline
Description
Change in arm circumference in centimeters (cm) over time from baseline to 12-weeks. Arm circumference will be measured objectively using a tape measure. A negative number will indicate a loss in arm circumference.
Time Frame
8, 16, 26, 52, 78 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English-speaking, community-dwelling adults ages 65-85 (unclear benefits of weight loss if >85 years) Obesity (Body mass index [BMI] ≥30kg/m^2; ≥2 chronic conditions; Documented change within 12-weeks of enrollment of a <5% weight change; Callahan Cognitive screen questionnaire score ≥3 (ability to consent); Older Americans Resources & Services ≥6 (disability); readiness to change ≥6/10; medical clearance by primary care provider. Exclusion Criteria: documented diagnosis in the electronic health record of dementia; documented diagnosis in the electronic health record of bariatric surgery in the past; untreated psychiatric, life-threatening, or terminal illness; nursing home or hospital admission in past three months advanced heart, liver, renal failure, non-skin cancer; weight loss contraindication; anti-obesity medications; elective surgery in next twelve months; recent (<1 month) Coronavirus Disease, 2019 (COVID-19) infection; current or past participation (in the past 12 months) in another weight-loss study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy S Plymale, BS
Phone
919-962-3412
Email
amynsp@email.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John A Batsis, MD
Phone
919-843-4096
Email
John.Batsis@unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Batsis, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Center for Aging and Health
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults

We'll reach out to this number within 24 hrs