ObesityNCT06044571
Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
A study testing Prescriptive and Behavioral in people with Obesity and Multiple Chronic Conditions, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Obesity, Multiple Chronic Conditions
- What is being tested?
- Prescriptive and Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria based on chart review at the time of screening (within 8 weeks of randomization):
- Community-dwelling adult living independently (not a resident of a nursing home or an assisted living);
- Aged 65-85 years (unclear benefits of weight loss if >85 years)
- Obesity (body mass index: ≥30 kg/m2);
- English-speaking;
- -≥2 chronic medical conditions that require ongoing care (excluding dementia and osteoporosis as a chronic condition) - these are based on Medicare' MCC (e.g., alcohol abuse, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal, lung, prostate), chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, drug/substance abuse, heart failure, hepatitis, Human Immunodeficiency Virus / Acquired Immunodeficiency Disease Syndrome, hyperlipidemia, hypertension, ischemic heart disease, schizophrenia/other psychotic disorders, stroke). We acknowledge that there are no fully defined definitions and hence we will be assessing MCC (or multimorbidity) in different manners;
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- medical clearance by PCP (Primary Care Provider)
- Callahan cognitive screen ≥ 3 correct items; items (a score of three or more correct items indicates an ability to consent);
- OARS (Older Americans Resources and Services)survey score of ≥12; (a score of 12 or more indicates no impairments or disability)
- Readiness to change score of ≥6/10;
Who cannot join
- Any individual who meets one or more of the following criteria will be excluded from participation based on chart review at the time of screening (within 8 weeks of randomization):
- documented diagnosis in the electronic health record of dementia of any type;
- documented diagnosis in the electronic health record of weight loss surgery in the past;
- untreated psychiatric disorder that would impair the ability to participate (bipolar, schizophrenia) based on medical record review;
- life-threatening illness;
- terminal illness (e.g., palliative care, hospice patient) based on medical record review whose life expectancy is <12 months as determined by a physician;
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- nursing home or hospital admission in past three months;
- advanced comorbidities based on medical record review;
- heart - recent hospital admission for heart failure, myocardial infarction, stroke in past 3 months, unstable disease (new york class III or IV congestive heart failure);
- chronic renal failure - chronic kidney disease stage IV or V (e.g., GFR [glomerular filtration rate] <30ml/min);
- non-skin cancer - history of requiring active treatment in the past year;
- liver failure or cirrhosis;
- chronic obstructive pulmonary disease - on oxygen or requiring steroids;
- weight loss contraindication as noted by the PCP;
- instability of weight loss, which is greater than 5% weight loss in the past 12 weeks;
- anti-obesity medications including orlistat, semaglutide, liraglutide, tirzepetide, naltrexone-bupropion and phentermine prior to initiation of study procedures;
- current use of bone acting medications (e.g., raloxifene, calcitonin, parathyroid hormone during the past year, Parathyroid Hormone Analogues (PTH-analogues [e.g., teriparatide, abaloparatide], sclerostin) inhibitors (romosozumbab), RANK ligand inhibitors (denosumab) or bisphosphonates during the last two years;
- osteoporosis by medical record (t-score -2.5 and below on hip or spine scan) or history of fragility fractures;
- elective surgery in next 12 months;
- recent (<1 mo) COVID-19 infection;
- current or past participation (in the past 12 months) in another weight-loss study;
- Planning on moving out of the area in the next 18 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNC Center for Aging and Health
Chapel Hill, North Carolina, 27599
About this study
Official title: Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults With Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial
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
Read the 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 52 weeks.
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 52-weeks. 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.
- Conditions
- Obesity, Multiple Chronic Conditions
- Being tested
- Prescriptive, Behavioral
- Medical subject headings
- Obesity, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrescriptiveOther
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).
BehavioralBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prescriptive | Active comparator | 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). Receives: Other: Prescriptive |
| Behavioral | Active comparator | 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:
1. barrier identification: problem-solving to identify and address barriers to meet goals
2. self-regulation: a focus on self-monitoring and behavior goals with feedback
3. 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. Receives: Behavioral: Behavioral |
| Responders to Prescriptive- Continue Prescriptive | Experimental | 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. Receives: Other: Prescriptive |
| Non-responders to Prescriptive- Switch to Behavioral | Experimental | 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. Receives: Behavioral: Behavioral |
| Non-responders to Prescriptive- Combination of Prescriptive and Behavioral | Experimental | 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. Receives: Other: Prescriptive; Behavioral: Behavioral |
| Responders to Behavioral- Continue Behavioral | Experimental | 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. Receives: Behavioral: Behavioral |
| Non-responders to Behavioral- Switch to Prescriptive | Experimental | 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. Receives: Other: Prescriptive |
| Non-responders to Behavioral- Combination of Prescriptive and Behavioral | Experimental | 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. Receives: Other: Prescriptive; Behavioral: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8, 26, 52 weeks
Secondary outcomes (42)
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)
Measured: 0, 8, 16, 26, 52 weeks
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)
Measured: 0, 8, 16, 26, 52 weeks
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 52-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)
Measured: 0, 8, 26, 52 weeks
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 52-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.
Measured: 0, 8, 26, 52 weeks
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.
Measured: 0, 8, 26, 52 weeks
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.
Measured: 0, 8, 26, 52 weeks
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
Measured: 0, 8, 26, 52 weeks
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
Measured: 0, 8, 26, 52 weeks
Proportion with greater than or equal to 5% weight loss
The proportion achieving a clinically significant 5% weight loss
Measured: 8, 26, 52 weeks
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.
Measured: 0, 26, 52 weeks
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.
Measured: 0, 26, 52 weeks
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.
Measured: 0, 26, 52 weeks
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.
Measured: 0, 8, 16, 26, 52
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.
Measured: 0, 8, 16, 26, 52 weeks
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.
Measured: 0, 8, 16, 26, 52 weeks
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.
Measured: 0, 8, 16, 26, 52 weeks
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)
Measured: 0, 8, 16, 26, 52 weeks
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
Measured: 0, 8, 16, 26, 52 weeks
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.
Measured: 0, 8, 16, 26, 52 weeks
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.
Measured: 0, 8, 16, 26, 52 weeks
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).
Measured: 0, 8, 16, 26, 52 weeks
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).
Measured: 0, 8, 16, 26, 52 weeks
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.
Measured: 0, 8, 16, 26, 52 weeks
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.
Measured: 0, 8, 16, 26, 52 weeks
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.
Measured: 0, 8, 16, 26, 52 weeks
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
Measured: 0, 8, 16, 26, 52 weeks
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)
Measured: 0, 8, 16, 26, 52 weeks
Fitbit use- Wear/non-wear time
Measurement using Fitbit data of the time spent during the day wearing the device.
Measured: 0, 8, 16, 26, 52 weeks
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
Measured: 0, 8, 16, 26, 52 weeks
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
Measured: 52 weeks
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 52-weeks. This is rated on a 1 (strongly disagree) to 10 (strongly agree) survey.
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
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
Measured: 0, 8, 26, 52 weeks
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
Measured: 0, 8, 26, 52 weeks
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.
Measured: 0, 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
Measured: 0, 52 weeks
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
Measured: 0, 52 weeks
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.
Measured: 0, 52 weeks
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
Measured: 0, 8, 26, 52 weeks
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.
Measured: 0, 8, 26, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start16 Apr 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- John Batsis, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044571
- Sponsor's protocol ID
- 23-1146
- Other IDs
- 1R01AG077163-01A1
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults With Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial
- ClinicalTrials.gov ID
- NCT06044571
- Acronym / sponsor ID
- 23-1146
- Conditions
- Obesity, Multiple Chronic Conditions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 52 weeks.
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 52-weeks. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
- 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
| Arm | Type | Receives |
|---|---|---|
| Prescriptive | Active comparator | Other: PrescriptiveA 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). |
| Behavioral | Active comparator | Behavioral: BehavioralHealth 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: 1. barrier identification: problem-solving to identify and address barriers to meet goals 2. self-regulation: a focus on self-monitoring and behavior goals with feedback 3. 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. |
| Responders to Prescriptive- Continue Prescriptive | Experimental | Other: PrescriptiveThe 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. |
| Non-responders to Prescriptive- Switch to Behavioral | Experimental | Behavioral: BehavioralParticipants 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. |
| Non-responders to Prescriptive- Combination of Prescriptive and Behavioral | Experimental | Other: Prescriptive, Behavioral: BehavioralParticipants 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. |
| Responders to Behavioral- Continue Behavioral | Experimental | Behavioral: BehavioralThe 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. |
| Non-responders to Behavioral- Switch to Prescriptive | Experimental | Other: PrescriptiveParticipants 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. |
| Non-responders to Behavioral- Combination of Prescriptive and Behavioral | Experimental | Other: Prescriptive, Behavioral: BehavioralParticipants 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria based on chart review at the time of screening (within 8 weeks of randomization):
- Community-dwelling adult living independently (not a resident of a nursing home or an assisted living);
- Aged 65-85 years (unclear benefits of weight loss if >85 years)
- Obesity (body mass index: ≥30 kg/m2);
- English-speaking;
Key exclusion criteria (22 listed)
- Any individual who meets one or more of the following criteria will be excluded from participation based on chart review at the time of screening (within 8 weeks of randomization):
- documented diagnosis in the electronic health record of dementia of any type;
- documented diagnosis in the electronic health record of weight loss surgery in the past;
- untreated psychiatric disorder that would impair the ability to participate (bipolar, schizophrenia) based on medical record review;
- life-threatening illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrescriptivePrescriptive 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). | Other | Non-responders to Behavioral- Combination of Prescriptive and Behavioral, Non-responders to Behavioral- Switch to Prescriptive, Non-responders to Prescriptive- Combination of Prescriptive and Behavioral, Prescriptive, Responders to Prescriptive- Continue Prescriptive |
| BehavioralBehavioral 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. | Behavioural | Behavioral, Non-responders to Behavioral- Combination of Prescriptive and Behavioral, Non-responders to Prescriptive- Combination of Prescriptive and Behavioral, Non-responders to Prescriptive- Switch to Behavioral, Responders to Behavioral- Continue Behavioral |
Primary outcome
Change in weight from baseline
Time frame: 8, 26, 52 weeks
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.
42 secondary outcomes
Change in Patient reported outcomes measurement information systems (PROMIS)- Global health
Time frame: 0, 8, 16, 26, 52 weeks
Change in Patient reported outcomes measurement information systems (PROMIS)- Physical function
Time frame: 0, 8, 16, 26, 52 weeks
Change in 30-second sit-to-stand from baseline
Time frame: 0, 8, 26, 52 weeks
Change in grip strength from baseline
Time frame: 0, 8, 26, 52 weeks
Change in gait speed from baseline
Time frame: 0, 8, 26, 52 weeks
Change in 6-minute walk from baseline
Time frame: 0, 8, 26, 52 weeks
Change in waist circumference from baseline
Time frame: 0, 8, 26, 52 weeks
Change in hip circumference from baseline
Time frame: 0, 8, 26, 52 weeks
Proportion with greater than or equal to 5% weight loss
Time frame: 8, 26, 52 weeks
Change in % body fat from baseline
Time frame: 0, 26, 52 weeks
Change in volume of visceral fat from baseline
Time frame: 0, 26, 52 weeks
Change in appendicular lean mass from baseline
Time frame: 0, 26, 52 weeks
Late-life function and disability instrument
Time frame: 0, 8, 16, 26, 52
Change in Pittsburgh Fatigability questionnaire
Time frame: 0, 8, 16, 26, 52 weeks
Change in Self-efficacy- exercise
Time frame: 0, 8, 16, 26, 52 weeks
Change in Self-efficacy- nutrition
Time frame: 0, 8, 16, 26, 52 weeks
Change in Self-efficacy- technology
Time frame: 0, 8, 16, 26, 52 weeks
Change in Goal setting- exercise
Time frame: 0, 8, 16, 26, 52 weeks
Change in Goal setting- nutrition
Time frame: 0, 8, 16, 26, 52 weeks
Change in Goal setting- technology
Time frame: 0, 8, 16, 26, 52 weeks
Change in social support for diet
Time frame: 0, 8, 16, 26, 52 weeks
Change in social support for exercise
Time frame: 0, 8, 16, 26, 52 weeks
Treatment self-regulation: diet
Time frame: 0, 8, 16, 26, 52 weeks
Treatment self-regulation: exercise
Time frame: 0, 8, 16, 26, 52 weeks
Change in caloric intake
Time frame: 0, 8, 16, 26, 52 weeks
Physical activity: community healthy activities model program for seniors
Time frame: 0, 8, 16, 26, 52 weeks
Patient activation measure
Time frame: 0, 8, 16, 26, 52 weeks
Fitbit use- Wear/non-wear time
Time frame: 0, 8, 16, 26, 52 weeks
Fitbit use- activity/steps
Time frame: 0, 8, 16, 26, 52 weeks
Attendance
Time frame: 52 weeks
Acceptability of Study Intervention
Time frame: 52 weeks
Percent of participants rating the intervention as acceptable
Time frame: 52 weeks
Telehealth satisfaction
Time frame: 52 weeks
Telehealth usability survey
Time frame: 52 weeks
Change in systolic blood pressure
Time frame: 0, 8, 26, 52 weeks
Change in diastolic blood pressure
Time frame: 0, 8, 26, 52 weeks
Change in low density lipoprotein blood levels
Time frame: 0, 52 weeks
Change in high density lipoprotein blood levels
Time frame: 0, 52 weeks
Change in total cholesterol blood levels
Time frame: 0, 52 weeks
Change in glucose blood levels
Time frame: 0, 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Batsis, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescriptive and Behavioral in people with Obesity and Multiple Chronic Conditions, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett R Sheppard, MA (919-423-9264, brett_sheppard@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight from baseline (time frame: 8, 26, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.