Telehealth Weight Loss Program for Obesity
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Must not be taking: Anti-obesity, Bone acting
Disqualifiers: Dementia, Untreated psychiatric disorder, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
411121314Eligibility Criteria
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.
+5 more
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.
+7 more
Trial Timeline
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
Participant Groups
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.
8Treatment groups
Experimental Treatment
Active Control
Group I: Responders to Prescriptive- Continue PrescriptiveExperimental Treatment1 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 BehavioralExperimental Treatment1 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 BehavioralExperimental Treatment1 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 BehavioralExperimental Treatment2 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 PrescriptiveExperimental Treatment1 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 BehavioralExperimental Treatment2 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: BehavioralActive Control1 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: PrescriptiveActive Control1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UNC Center for Aging and HealthChapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Safe and effective management of the obese patient. [2022]The prevalence of overweight and obesity has increased dramatically in the recent decades, and obesity is now a major public health problem. Obesity negatively influences an individual's health by increasing mortality and raising the risk for multiple medical conditions such as type 2 diabetes mellitus, hypertension, dyslipidemia, and coronary heart disease. In addition, the obese individual is often the brunt of social discrimination. Weight loss has been shown to reduce the risk for many of these comorbid conditions. A multifaceted approach to the obese patient should include identifying potential causes for weight gain, outlining medical conditions that would benefit by weight loss, and tailoring a weight loss program that is safe and effective for the individual. Components of a successful weight loss program include dietary intervention, recommendations for physical activity, behavior modification, and, in a select group of patients, pharmacologic or surgical intervention.
Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. [2021]Behavioural weight loss programs are effective first-line treatments for obesity and are recommended by the US Preventive Services Task Force. Gaining an understanding of intervention components that are found helpful by different demographic groups can improve tailoring of weight loss programs. This paper examined the perceived helpfulness of different weight loss program components.
[A telemetrically-guided program for weight reduction in overweight subjects (the SMART study)]. [2017]Compliance with weight reducing programs can be improved by intensive care and control. We tested a telemetrically-guided weight reduction program in overweight and obese persons.
An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. [2022]To evaluate 3- and 6-month weight-loss outcomes achieved when physicians refer overweight/obese patients to an automated 3-month Internet-based behavioral weight-loss intervention.
Hospitalists' utilization of weight loss resources with discharge texts and primary care contact: a feasibility study. [2016]Obesity affects a large proportion of the U.S. population, and hospitalizations may serve as an opportunity to promote weight loss. We sought to determine if multidisciplinary patient-centered inpatient weight loss intervention that included counseling, consults, post-discharge telephone text messages, and primary care follow up was feasible.
Outcomes and utilization of a low intensity workplace weight loss program. [2021]Obesity is related to high health care costs and lost productivity in the workplace. Employers are increasingly sponsoring weight loss and wellness programs to ameliorate these costs. We evaluated weight loss outcomes, treatment utilization, and health behavior change in a low intensity phone- and web-based, employer-sponsored weight loss program. The intervention included three proactive counseling phone calls with a registered dietician and a behavioral health coach as well as a comprehensive website. At six months, one third of those who responded to the follow-up survey had lost a clinically significant amount of weight (≥5% of body weight). Clinically significant weight loss was predicted by the use of both the counseling calls and the website. When examining specific features of the web site, the weight tracking tool was the most predictive of weight loss. Health behavior changes such as eating more fruits and vegetables, increasing physical activity, and reducing stress were all predictive of clinically significant weight loss. Although limited by the low follow-up rate, this evaluation suggests that even low intensity weight loss programs can lead to clinical weight loss for a significant number of participants.
Randomized controlled pilot study testing use of smartphone technology for obesity treatment. [2022]The established interventions for weight loss are resource intensive which can create barriers for full participation and ultimate translation. The major goal of this pilot study was to evaluate the feasibility, acceptability, and preliminary efficacy of theoretically based behavioral interventions delivered by smartphone technology.
Using the Behaviour Change Wheel for Designing an Online Platform for Healthy Weight Loss - "POEmaS". [2022]Behaviour change is a key point in weight management. Digital health interventions are attractive tools to deliver behaviour interventions for weight loss, due to the potential to reach a large number of people. We aimed to report how the Behaviour Change Wheel (BCW) was used to develop and implement a web platform to promote weight loss in Brazilian adults with overweight and obesity. Moreover, we aimed to describe the first 12 weeks of usage of the platform in a randomized controlled trial.
Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. [2018]An ongoing clinical trial is testing the efficacy of web telematic support in a structured program for obesity treatment and diabetes prevention. Participants were recruited from two tertiary-care hospitals and randomized to receive either a telematic intervention (TI) supported by PREDIRCAM2 web platform or a non-telematic intervention (NTI). All receive 1-year follow-up. Both interventions consist of tailored dietary and exercise prescriptions, based on a Mediterranean dietary pattern and general WHO exercise recommendations for adults. At 6 months, both groups have received 7 contacts, 3 exclusively telematic for the TI group. This is a preliminary result intention-to-treat analysis. One hundred eighty-three participants were recruited, with a mean body mass index of 34.75 ± 2.75 kg/m2. General dropout rate at 6 months was 26.8%. Weight changes were statistically significant at months 3 and 6 compared to baseline, -2.915 ± 0.24 kg, -3.29 ± 0.36 kg, respectively (P < 0.001), but not statistically significant between the 3- and 6-month time points -0.37 ± 0.21 kg (P = 0.24). Mean group differences showed that the TI group lost 1.61 ± 1.88 kg more than the NTI group (P = 0.39). Waist, waist/hip ratio, resting heart rate, blood pressure, HbA1c, and low-density lipoprotein cholesterol also showed statistically significant changes at 6 months, with no significant differences between groups. Weight loss in the TI group shows similar results as the usual care NTI group for weight loss and control of obesity comorbidities. At completion of the clinical trial, these results will be reevaluated to assess the potential role of web support in weight-loss maintenance and its cost-effectiveness.
Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. [2020]Insurers and employers are increasingly offering lifestyle and weight-loss coaching programs; however, few evaluations have examined their effectiveness. Our objectives were to determine whether level of program engagement was associated with differences in healthcare utilization and weight pre/post coaching. We conducted a retrospective evaluation of enrollees in an insurer-based telephonic health coaching program in Maryland (2013-2014). Our independent variables were program engagement benchmarks (≥3 and ≥6 sessions). Our dependent variables included change in outpatient and emergency department (ED) visits (more visits post program, fewer visits post, or no change pre-post) and associated costs (difference pre-post) using claims data. We calculated mean percent weight change from baseline. We used multivariate-adjusted linear and multinomial logistic regression, as appropriate, to examine the association between outcomes and engagement benchmarks. We included 225 enrollees with mean age 50.7 years, 81.3% women, and mean body mass index of 35.0 kg/m2. Most participants focused on weight management (75.6%) and improving general health (57.8%). Few individuals had outpatient or ED visits, and no significant changes in healthcare utilization were associated with program engagement. Among the weight management subgroup (n = 170), mean weight change was -2.1% (SD 5.1). Participants achieved significantly greater weight loss if they met the 6-session engagement benchmark (β -3.5%, p < 0.01). Weight management is a popular focus for health coaching participants, and these programs can achieve modest weight loss. Programs should consider designing and testing strategies that promote engagement, given that weight-loss success was improved if participants completed at least 6 coaching sessions.
Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. [2021]To explore a telehealth-based lifestyle therapeutics (THBC) program on weight loss (WL) and program satisfaction in an employer population.
A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. [2021]Intensive behavioral obesity treatments face scalability challenges, but evidence is lacking about which treatment components could be cut back without reducing weight loss. The Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity (Opt-IN) study applied the Multiphase Optimization Strategy to develop an entirely remotely delivered, technology-supported weight-loss package to maximize the amount of weight loss attainable for ≤$500.
Video telehealth for weight maintenance of African-American women. [2022]We evaluated the effect of home telehealth on weight maintenance after a group-based weight loss programme. The home telehealth intervention comprised telephone counselling and home Internet-enabled digital video recorders (DVRs) with three channels of video programmes. The video content provided reinforcement and support to promote problem solving, prevent relapse and sustain motivation. Eighty-eight obese or overweight African-American women were randomized to receive monthly telephone counselling (control) or the home telehealth intervention. The weight change during maintenance was not significant in either group (0.6 kg in the intervention group, 0.0 kg in the control group), and there was no significant difference between them. Changes in diet, physical activity, social support and self-efficacy during the maintenance period did not differ significantly between groups. DVR use was low: during the intervention, the number of valid DVR viewings ranged from zero to 42 per person. DVR use was positively associated with previous attendance at the weight loss classes. Home video-based telehealth is a new method of delivering a weight loss maintenance intervention to African-American women. It had no effect on weight maintenance in the present study.
Obesity paradigm and web-based weight loss programs: an updated systematic review and meta-analysis of randomized controlled trials. [2021]Web-based therapeutic approaches are new and attractive tools for primary health care systems due to their time and cost-saving nature and their accessibility for different populations. The aim of the current systematic review and meta-analysis is to summarize the results of studies evaluating the effect of web-based interventional programs on weight loss among overweight and obese individuals.