Telehealth Weight Loss Program for Obesity

Overseen By John A Batsis, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Anti-obesity, Bone acting

Disqualifiers: Dementia, Untreated psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using anti-obesity medications or certain bone-acting medications. It's best to discuss your specific medications with the trial team.

Is the Telehealth Weight Loss Program for Obesity safe for humans?

The available research on telehealth weight loss programs, including those with health coaching and web-based support, suggests they are generally safe for humans. These programs focus on lifestyle changes like diet and exercise, and no significant safety concerns have been reported in the studies. ^{1 2 3 4 5}

How is the Telehealth Weight Loss Program for Obesity different from other treatments?

This treatment is unique because it uses telehealth (remote healthcare services) to deliver a behavioral weight loss program, making it more accessible and potentially more cost-effective than traditional in-person methods. It combines health coaching and medically tailored interventions, which are designed to be delivered entirely online, allowing for greater scalability and convenience for participants. ^{6 7 8 9 10}

What data supports the effectiveness of this treatment for obesity?

Research shows that behavioral weight loss programs, which include components like dietary changes, physical activity, and behavior modification, are effective first-line treatments for obesity. Additionally, telehealth and internet-based programs have been found to improve compliance and achieve weight loss in overweight and obese individuals. ^{10 11 12 13 14}

Who Is on the Research Team?

John A Batsis, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 65-85 with obesity (BMI ≥30) and at least two chronic conditions as defined by Medicare. Participants must be able to consent, have a stable weight in the past 12 weeks, and get medical clearance from their doctor. Those with recent COVID-19, dementia, bariatric surgery history, or certain severe health issues cannot join.

Inclusion Criteria

Documented change within 12-weeks of enrollment of a <5% weight change

You are willing and motivated to make changes in your life, with a readiness score of at least 6 out of 10.

My BMI is 30 or higher.

Exclusion Criteria

You are unable to participate if you are experiencing significant and unexplained weight loss.

My medical records show a diagnosis of dementia.

I have had bariatric surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive either a prescriptive or behavioral weight loss intervention

8 weeks

Telehealth sessions

Adaptive Treatment

Non-responders are re-randomized to a different intervention strategy

44 weeks

Telehealth sessions

Follow-up

Participants are monitored for weight maintenance and health outcomes

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioural
• Prescriptive

Trial Overview The study tests different combinations of prescriptive and behavioral interventions to find effective weight loss strategies for older adults with multiple chronic conditions using a SMART design. It aims to identify treatments that improve health outcomes and reduce healthcare costs.

How Is the Trial Designed?

Group I: Responders to Prescriptive- Continue Prescriptive Experimental Treatment 1 Intervention

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.

Group II: Responders to Behavioral- Continue Behavioral Experimental Treatment 1 Intervention

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.

Group III: Non-responders to Prescriptive- Switch to Behavioral Experimental Treatment 1 Intervention

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.

Group IV: Non-responders to Prescriptive- Combination of Prescriptive and Behavioral Experimental Treatment 2 Interventions

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.

Group V: Non-responders to Behavioral- Switch to Prescriptive Experimental Treatment 1 Intervention

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

Group VI: Non-responders to Behavioral- Combination of Prescriptive and Behavioral Experimental Treatment 2 Interventions

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.

Group VII: Behavioral Active Control 1 Intervention

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.

Group VIII: Prescriptive Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Obesity is a significant public health issue that increases the risk of serious health conditions like type 2 diabetes, hypertension, and heart disease, highlighting the importance of effective weight management.

A successful weight loss program should be personalized and may include dietary changes, physical activity, behavior modification, and, for some patients, medications or surgery to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective management of the obese patient. Collazo-Clavell, ML.[2022]

In a study of 236 participants from the POWER Hopkins Trial, individual telephone sessions, online weight tracking, and coach reviews were rated as the most helpful components of a behavioral weight loss program, indicating their effectiveness in supporting weight loss efforts.

Demographic factors influenced perceptions of helpfulness, with older adults, Black participants, and those with lower education levels finding the intervention components more beneficial, suggesting the need for tailored approaches in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Dalcin, AT., Jerome, GJ., Fitzpatrick, SL., et al.[2021]

A telemetrically-guided weight reduction program significantly helped 200 overweight and obese participants lose an average of 6.7 kg and reduce body fat by 5.1 kg over the first six months, along with improvements in metabolic and cardiovascular risk markers.

Participants who continued with telemonitoring maintained their weight loss and health improvements, while those without telemonitoring support experienced weight regain and worsening health metrics, highlighting the efficacy of ongoing support in weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A telemetrically-guided program for weight reduction in overweight subjects (the SMART study)]. Körtke, H., Frisch, S., Zittermann, A., et al.[2017]

A study involving 154 overweight or obese patients showed that those referred to an automated Internet-based behavioral weight-loss intervention lost significantly more weight than those in an education-only control group, with average losses of 5.5 kg at 3 months and 5.4 kg at 6 months.

Over half of the participants in the Internet-based intervention achieved a clinically significant weight loss of 5% or more of their initial body weight, indicating the intervention's effectiveness in promoting weight control behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. Thomas, JG., Leahey, TM., Wing, RR.[2022]

A feasibility study involving 25 obese hospitalized patients showed that a comprehensive weight loss intervention, including counseling and follow-up, is practical and can be implemented effectively during hospital stays.

Patients in the intervention group lost an average of 3.0 kg over 6 months, while the control group gained weight, indicating that the intervention may lead to sustained weight loss improvements post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospitalists' utilization of weight loss resources with discharge texts and primary care contact: a feasibility study. Harris, CM., Cheskin, LJ., Khaliq, W., et al.[2016]

In a low-intensity, employer-sponsored weight loss program involving 3 counseling calls and a comprehensive website, one third of participants lost at least 5% of their body weight after six months, indicating the program's efficacy.

Utilization of both counseling and the website, particularly the weight tracking tool, was linked to successful weight loss, along with positive health behavior changes like increased fruit and vegetable intake and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and utilization of a low intensity workplace weight loss program. Carpenter, KM., Lovejoy, JC., Lange, JM., et al.[2021]

In a pilot study involving 68 obese adults over six months, those receiving intensive counseling combined with smartphone self-monitoring lost an average of 5.4 kg, indicating that this approach may enhance weight loss efforts.

The study suggests that smartphone technology can be a feasible and acceptable tool for supporting behavioral interventions in weight loss, particularly when combined with counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot study testing use of smartphone technology for obesity treatment. Allen, JK., Stephens, J., Dennison Himmelfarb, CR., et al.[2022]

The study involved 809 Brazilian adults with overweight and obesity, using the Behaviour Change Wheel (BCW) framework to develop a web platform aimed at promoting weight loss through targeted behavior changes over a 24-week intervention.

The platform's functionalities were categorized based on the BCW components, showing that motivation-driven features were accessed the most, indicating their potential effectiveness in engaging users, while capability-driven features had lower usage, suggesting areas for improvement in behavior diagnosis and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Behaviour Change Wheel for Designing an Online Platform for Healthy Weight Loss - "POEmaS". Beleigoli, AM., Andrade, AQ., Diniz, MFH., et al.[2022]

In a clinical trial involving 183 participants with obesity, both telematic intervention (TI) and non-telematic intervention (NTI) groups showed significant weight loss at 3 and 6 months, with an average loss of approximately 3 kg, indicating the effectiveness of both approaches in obesity treatment.

The TI group experienced a slightly greater weight loss (1.61 kg more than NTI), but this difference was not statistically significant, suggesting that while web support may enhance weight loss, it does not outperform standard care in this preliminary analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. Alcántara-Aragón, V., Rodrigo-Cano, S., Lupianez-Barbero, A., et al.[2018]

In a study of 225 participants in a telephonic health coaching program, those who engaged in at least 6 coaching sessions experienced a significant average weight loss of -3.5%, compared to a modest overall weight change of -2.1% for the group.

Despite the focus on weight management, the study found no significant changes in healthcare utilization or costs associated with program engagement, suggesting that while coaching can aid weight loss, it may not impact healthcare visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. Reid, N., Bennett, W., Coughlin, J., et al.[2020]

The telehealth-based lifestyle therapeutics (THBC) program was effective in promoting weight loss, with obese participants losing an average of 3.6% of their body weight compared to 2.5% for overweight participants, indicating a significant difference based on initial BMI category.

There were no differences in weight loss outcomes between men and women, and participants reported high satisfaction with the program, suggesting that THBC is a valuable tool for weight management in an employer population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. Johnson, KE., Alencar, MK., Miller, B., et al.[2021]

The Opt-IN study, involving 562 adults with obesity, identified an effective weight-loss treatment package that included 12 coaching calls, buddy training, and primary care provider reports, resulting in an average weight loss of 6.1 kg for a cost of $427 per person.

By systematically evaluating treatment components, the study found that increasing coaching calls from 12 to 24 did not enhance weight loss, allowing for a more cost-effective and efficient obesity treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. Spring, B., Pfammatter, AF., Marchese, SH., et al.[2021]

The home telehealth intervention, which included telephone counseling and video support, did not significantly impact weight maintenance among 88 obese or overweight African-American women after a weight loss program, with both groups showing minimal weight change.

Low usage of the digital video recorders (DVRs) suggests that the video content may not have been effectively utilized, indicating a potential barrier to the success of the telehealth intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video telehealth for weight maintenance of African-American women. Gerber, BS., Schiffer, L., Brown, AA., et al.[2022]

A systematic review of eight studies found that web-based interventions had a weak and non-significant effect on weight loss among overweight and obese individuals, with an average weight difference of only 0.56 kg.

The lack of effectiveness was attributed to factors such as unadjusted baseline weights and low study quality, suggesting that future research should focus on improving these aspects to better evaluate the potential of web-based weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity paradigm and web-based weight loss programs: an updated systematic review and meta-analysis of randomized controlled trials. Jahangiry, L., Farhangi, MA.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Safe and effective management of the obese patient. [2022]

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Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[A telemetrically-guided program for weight reduction in overweight subjects (the SMART study)]. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Hospitalists' utilization of weight loss resources with discharge texts and primary care contact: a feasibility study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes and utilization of a low intensity workplace weight loss program. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot study testing use of smartphone technology for obesity treatment. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Using the Behaviour Change Wheel for Designing an Online Platform for Healthy Weight Loss - "POEmaS". [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. [2021]

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A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Video telehealth for weight maintenance of African-American women. [2022]

14. Bangladesh pubmed.ncbi.nlm.nih.gov

Obesity paradigm and web-based weight loss programs: an updated systematic review and meta-analysis of randomized controlled trials. [2021]