Phone-Based Weight-Loss Support for Obesity

Overseen By Meena Shankar, MS, RD, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Weight loss medications

Disqualifiers: Bariatric surgery, Cancer, Dementia, others

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

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how different phone-based support schedules assist individuals in maintaining weight loss. Participants will initially join a weight loss program and then be divided into two groups: one group receives calls when at risk of regaining weight or upon request, while the other receives monthly calls. The trial targets individuals with obesity (BMI 30-45) who own a smartphone and have lost at least 5% of their starting weight. As an unphased trial, it provides a unique opportunity to explore personalized support strategies for sustaining weight loss.

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 weight loss medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers found that participants in the ADAPTIVE Extended-Care Program did not regain more weight than those using other methods, suggesting the program is easy to follow. No significant reports of serious side effects emerged.

For the STATIC Extended-Care Program, research has shown that participants generally lost weight without major problems. These programs have been successfully used for weight management for some time, with no major safety concerns reported for either phone-based program.

Both approaches aim to support weight loss and are designed to be safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the phone-based weight-loss support programs because they offer personalized and flexible approaches to maintaining weight loss, which is a major challenge in obesity management. The ADAPTIVE Extended-Care Program is unique because it provides intervention calls only when participants are deemed at high risk for weight regain or when they request help, offering a tailored approach. On the other hand, the STATIC Extended-Care Program follows a fixed once-per-month call schedule, similar to current standard programs, ensuring regular support. These methods differ from traditional in-person or self-guided weight-loss strategies by using technology to provide timely and potentially more effective support.

What evidence suggests that this trial's treatments could be effective for weight loss maintenance?

This trial will compare two types of phone-based weight-loss support programs. Participants in the ADAPTIVE Extended-Care Group receive support when they are at high risk of regaining weight or when they request a session. Studies have shown that this approach helps people maintain their weight loss by providing support exactly when needed most.

Participants in the STATIC Extended-Care Group receive regular support once a month. This method has also been effective in helping people maintain their weight loss over time. Research suggests that both approaches can work well, with no major differences in weight regain between the two. Both programs offer valuable support for keeping weight off in the long run. ^{1 2 6 7 8}

Who Is on the Research Team?

Kathryn Ross, PhD, MPH

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Project STAR is for individuals with obesity who have lost at least 5% of their initial weight and have a BMI between 30.0-45.0 kg/m2. Participants must own a compatible smartphone with a data plan, weigh less than 396 pounds, and not be pregnant or breastfeeding. Those with certain medical conditions or treatments are excluded.

Inclusion Criteria

You have a body mass index (BMI) between 30 and 45, which indicates that you may be overweight or obese.

I lost 5% or more of my starting weight in the first 4 months.

Weight ≤ 396 pounds (due to scale limit)

Exclusion Criteria

I am currently taking medication to lose weight.

I have lost 10 pounds or more in the last 6 months.

You are currently nursing a baby.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Behavioral Weight Management Program

Participants receive an initial in-person, group-based behavioral weight management program

4 months

Extended-Care Intervention

Participants receive phone-based extended-care intervention based on ADAPTIVE or STATIC schedule

8 months

Monthly phone calls

Follow-up

Participants are monitored for weight maintenance and safety

12 months

Follow-up visits at Month 12 and Month 24

What Are the Treatments Tested in This Trial?

Interventions

• ADAPTIVE Extended-Care Program
• STATIC Extended-Care Program

Trial Overview The trial compares two phone-based extended-care programs for maintaining weight loss: an ADAPTIVE program that intervenes when participants are 'high risk' for regaining weight, and a STATIC program with regular monthly calls.

How Is the Trial Designed?

Group I: ADAPTIVE Extended-Care Group Experimental Treatment 1 Intervention

Participants randomized to the ADAPTIVE extended-care program will receive extended-care intervention phone delivered only if either 1) an algorithm developed by our study team detects that a participant is at "high risk" for weight regain or 2) the participant self-initiates a request for a session.

Group II: STATIC Extended-Care Group Active Control 1 Intervention

Participants randomized to the STATIC extended-care program will receive the extended-care intervention phone calls on a fixed, once-per-month schedule (the schedule currently used in gold-standard weight maintenance programs).

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12455375/

Adaptive vs Monthly Support for Weight-Loss Maintenance In this randomized clinical trial, participants in both conditions were successful at maintaining initial weight loss 20 months after the end of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04116853

Support and Tracking to Achieve Results (Project STAR) The study team will evaluate methods for providing phone-based extended-care to support weight loss maintenance. The investigators propose to conduct a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11161849/

An Adaptive Telephone Coaching Intervention for Patients ... This randomized clinical trial compares brief and extended coaching programs for patients in an online weight loss program who had achieved less than 4% of ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819706

An Adaptive Telephone Coaching Intervention for Patients ... The provision of 3 or 12 weeks of telephone coaching to those with suboptimal weight loss at 1-month improved weight loss outcomes and engagement with the ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/53/NCT04116853/Prot_SAP_000.pdf

Evaluation of an Adaptive Intervention for Weight Loss ... We propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (only when ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5798936/

Real-World Effectiveness of a Medically Supervised Weight ... In those with 5-year follow-up, weight loss between 5.0 and 9.9% below baseline occurred in 16.3% (SE = 0.004, 95% CI = 15.3% – 17.2%) and ...

7. sciencedirect.com sciencedirect.com/science/article/am/pii/S1551714424002908

Design of Project STAR: A randomized controlled trial ... Design of Project STAR: A Randomized Controlled Trial Evaluating the Impact of an. Adaptive Intervention on Long-Term Weight-Loss Maintenance.

8. healthsnap.io healthsnap.io/the-impact-of-virtual-care-programs-on-weight-management-outcomes-in-2024/

The Impact of Virtual Care Programs on Weight ... The study concluded that patients who participated in CCM had a 25% higher likelihood of achieving significant weight loss compared to those not ...