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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
Must not have
Currently taking medications for weight loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 12
Awards & highlights

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently on medication for weight loss.

Timeline

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

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

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
549 Previous Clinical Trials
135,370 Total Patients Enrolled
1 Trials studying Obesity
28 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,314,762 Total Patients Enrolled
453 Trials studying Obesity
588,625 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
~52 spots leftby Jan 2025