An interventional study of Prescriptive and Behavioral in Obesity and Multiple Chronic Conditions, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 180 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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):
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, , depression, diabetes, drug/substance abuse, heart failure, hepatitis, / 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;
Exclusion Criteria:
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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Prescriptive
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.
Behavioral: Behavioral
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.
Other: Prescriptive
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.
Behavioral: Behavioral
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.
Other: Prescriptive · Behavioral: Behavioral
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.
Behavioral: Behavioral
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.
Other: Prescriptive
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.
Other: Prescriptive · Behavioral: Behavioral
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).
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.
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.
Time frame: 8, 26, 52 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 0, 8, 26, 52 weeks
Proportion with greater than or equal to 5% weight loss
The proportion achieving a clinically significant 5% weight loss
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 0, 8, 26, 52 weeks
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