← Back to Search

Phone-Based Weight-Loss Support for Obesity

N/A

Waitlist Available

Led By Kathryn Ross, PhD, MPH

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lose ≥ 5% of baseline weight during the initial weight loss intervention (Month 0 to Month 4)

Be older than 18 years old

Must not have

Current use of weight loss medications

Weight loss of ≥ 10 lb in prior 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; month 4; month 12; month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the weight-loss results of two different schedules of phone-based care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve behavioral support via phone without medications or invasive procedures, no direct side effects from the interventions themselves are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking medication to lose weight.

Select...

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

Select...

I don't have my doctor's approval to join, and I have diabetes, high blood pressure, or heart disease.

Select...

I have had weight loss surgery in the past.

Select...

I cannot walk 1/4 mile without stopping due to physical limitations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; month 4; month 12; month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; month 4; month 12; month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; month 4; month 12; month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in weight regain of the ADAPTIVE group compared to the STATIC group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ADAPTIVE Extended-Care GroupExperimental Treatment1 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 GroupActive Control1 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).

0 / 6Eligibility criteria met