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Can a tailored telehealth diet help older adults lose weight safely?

NCT ID NCT06044571

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests different telehealth weight loss programs for adults aged 65-85 who have obesity and at least two chronic health conditions. Participants will receive a personalized diet and exercise plan designed to be safe for their specific health needs. The goal is to find the best first-line approach to help them lose weight and improve their quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
diet and exercise prescription
What this could lead to
If successful, this could identify the best telehealth weight loss approach for older adults with multiple health issues, potentially improving their health and reducing disability.
What could go wrong
This is an early-stage study with only 180 participants, so results may not apply to everyone. Weight loss in older adults carries risks like muscle loss or low blood sugar, which the study aims to minimize but cannot eliminate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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; 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): * 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; * 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.

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Conditions

The condition(s) this trial relates to.

Multiple Chronic Conditions Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UNC Center for Aging and Health

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.