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Lifestyle Intervention + Stress Management for Obesity (RESET Trial)

N/A

Recruiting

Led By Tiffany L Carson, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 12

Awards & highlights

RESET Trial Summary

This trial will test whether adding stress management to a behavioral weight loss program helps black women with obesity lose more weight.

Who is the study for?

This trial is for adult black females with obesity, defined as a BMI of at least 30 kg/m^2, who are experiencing high stress levels. Participants should not be pregnant or planning pregnancy within the year, have no recent psychiatric hospitalizations, substance abuse issues, eating disorders, or medical conditions that would make weight loss unsafe.Check my eligibility

What is being tested?

The study compares two programs: one combines a behavioral weight loss intervention with stress management training; the other offers just the weight loss program. Both groups will attend 26 sessions to see which approach is more effective in reducing weight and stress.See study design

What are the potential side effects?

Since this trial involves lifestyle interventions and educational tools rather than medication, side effects may include typical responses to diet changes or exercise such as muscle soreness or fatigue but are generally minimal compared to drug treatments.

RESET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 12

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

12-month mean weight change of participants using SECA scale

4-month mean weight change of participants using SECA scale

Secondary outcome measures

mean change in perceived stress using Perceived Stress Scale-10 score

RESET Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Weight Loss Plus Stress ManagementExperimental Treatment1 Intervention

Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training

Group II: Weight Loss OnlyActive Control1 Intervention

Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,152 Total Patients Enrolled

1 Trials studying Obesity

28 Patients Enrolled for Obesity

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

2,358 Previous Clinical Trials

4,314,734 Total Patients Enrolled

446 Trials studying Obesity

588,598 Patients Enrolled for Obesity

Tiffany L Carson, PhDPrincipal InvestigatorMoffitt Cancer Center

2 Previous Clinical Trials

140 Total Patients Enrolled

1 Trials studying Obesity

28 Patients Enrolled for Obesity

Media Library

Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics Clinical Trial Eligibility Overview. Trial Name: NCT04335799 — N/A

Obesity Research Study Groups: Weight Loss Plus Stress Management, Weight Loss Only

Obesity Clinical Trial 2023: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics Highlights & Side Effects. Trial Name: NCT04335799 — N/A

Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics 2023 Treatment Timeline for Medical Study. Trial Name: NCT04335799 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to partake in this research experiment?

"In order to be admitted into this clinical trial, patients must have a body mass index (BMI) of 30 or greater and an age between 21-75. Presently, there are 340 participants registered for the study."

Answered by AI

Could you please provide the aggregate count of participants in this experiment?

"Affirmative. The information on clinicaltrials.gov demonstrates that this research endeavour, which was initially published on October 29th 2021, is actively searching for participants. 340 individuals are needed to be recruited from a single site."

Answered by AI

Is enrollment for this study currently open?

"According to data on clinicaltrials.gov, this trial is still enrolling participants; it was posted in late October 2021 and the information was most recently refreshed at the end of August 2022."

Answered by AI