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

255 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule on weight loss maintenance. The study team will provide participants with an initial behavioral weight management program, and then randomize participants who successfully achieve a clinically-significant weight loss of ≥5% to one of the two extended-care conditions

Research Team

Kathryn Ross, PhD, MPH

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+