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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; month 4; month 12; month 24
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I lost 5% or more of my starting weight in the first 4 months.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in weight regain of the ADAPTIVE group compared to the STATIC group
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).
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,349 Previous Clinical Trials
719,645 Total Patients Enrolled
36 Trials studying Obesity
26,702 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,376 Previous Clinical Trials
4,315,512 Total Patients Enrolled
451 Trials studying Obesity
588,709 Patients Enrolled for Obesity
Kathryn Ross, PhD, MPHPrincipal InvestigatorUniversity of Florida
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Eligibility Criteria:
This trial includes the following eligibility 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.I don't have my doctor's approval to join, and I have diabetes, high blood pressure, or heart disease.I do not have any health conditions that prevent me from losing weight or completing a study.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.I have had weight loss surgery in the past.You have a pacemaker implanted.I cannot walk 1/4 mile without stopping due to physical limitations.
Research Study Groups:
This trial has the following groups:- Group 1: ADAPTIVE Extended-Care Group
- Group 2: STATIC Extended-Care Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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