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

NCT06044571 | Recruiting DMC

• 2 other identifiers: 23-11461R01AG077163-01A1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Multiple Chronic Conditions

Outcome Measures

Primary Outcomes (1)

• 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.

  8, 26, 52 weeks

Secondary Outcomes (42)

• Change in Patient reported outcomes measurement information systems (PROMIS)- Global health

  0, 8, 16, 26, 52 weeks

• Change in Patient reported outcomes measurement information systems (PROMIS)- Physical function

  0, 8, 16, 26, 52 weeks

• Change in 30-second sit-to-stand from baseline

  0, 8, 26, 52 weeks

• Change in grip strength from baseline

  0, 8, 26, 52 weeks

• Change in gait speed from baseline

  0, 8, 26, 52 weeks

Study Arms (8)

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).

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.

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.

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.

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.

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.

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.

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.

Other: Prescriptive; Behavioral: Behavioral

Interventions

Prescriptive OTHER

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).

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

Behavioral BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UNC Center for Aging and Health

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Multiple Chronic Conditions

Interventions

Directive Counseling

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• John Batsis, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brett R Sheppard, MA

CONTACT

919-423-9264; brett_sheppard@unc.edu

John A Batsis, MD

CONTACT

919-843-4096; John.Batsis@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: April 16, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)