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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
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

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
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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:
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I am currently taking medication to lose weight.
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I have lost 10 pounds or more in the last 6 months.
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I don't have my doctor's approval to join, and I have diabetes, high blood pressure, or heart disease.
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I have had weight loss surgery in the past.
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I cannot walk 1/4 mile without stopping due to physical limitations.

Timeline

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

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).

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,140 Total Patients Enrolled
37 Trials studying Obesity
21,010 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,636 Total Patients Enrolled
459 Trials studying Obesity
589,295 Patients Enrolled for Obesity
Kathryn Ross, PhD, MPHPrincipal InvestigatorUniversity of Florida

Media Library

ADAPTIVE Extended-Care Program Clinical Trial Eligibility Overview. Trial Name: NCT04116853 — N/A
Obesity Research Study Groups: ADAPTIVE Extended-Care Group, STATIC Extended-Care Group
Obesity Clinical Trial 2023: ADAPTIVE Extended-Care Program Highlights & Side Effects. Trial Name: NCT04116853 — N/A
ADAPTIVE Extended-Care Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04116853 — N/A
~12 spots leftby Dec 2024
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