340 Participants Needed

Lifestyle Intervention + Stress Management for Obesity

(RESET Trial)

DR
TL
AP
TC
Overseen ByTiffany Carson, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking medications specifically for weight loss.

What data supports the effectiveness of the treatment Lifestyle Intervention + Stress Management for Obesity?

The Diabetes Prevention Program (DPP) showed that an intensive lifestyle intervention, which includes diet and exercise, led to significant weight loss and reduced the risk of developing type 2 diabetes. This suggests that similar lifestyle changes could be effective for managing obesity.12345

Is the Lifestyle Intervention + Stress Management for Obesity safe for humans?

The Diabetes Prevention Program Intensive Lifestyle Intervention (DPP-ILI) has been studied in diverse groups and shown to be safe for humans, focusing on diet and exercise to prevent diabetes. While specific safety data on the addition of stress management is not detailed, the core lifestyle intervention has been safely used in various populations.12367

How is the Lifestyle Intervention + Stress Management treatment for obesity unique compared to other treatments?

This treatment is unique because it combines the Diabetes Prevention Program Intensive Lifestyle Intervention, which focuses on weight loss and physical activity, with stress management training, addressing both physical and mental health aspects to prevent diabetes in high-risk individuals.12348

Research Team

TL

Tiffany Carson, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Elevated stress levels based on perceived stress scale score
Self-identified as black race

Exclusion Criteria

I am currently on medication for weight loss.
Pregnant or are planning to become pregnant in the next year
History of substance abuse or eating disorder
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioral weight loss intervention with or without stress management for 26 sessions

4 months
26 sessions

Follow-up

Participants are monitored for weight change and stress levels after treatment

8 months

Treatment Details

Interventions

  • Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
  • Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

The Intensive Lifestyle Intervention (ILI) in the Diabetes Prevention Program (DPP) effectively helped approximately 3800 high-risk adults with prediabetes achieve weight loss through dietary and exercise modifications, demonstrating a practical approach to delaying or preventing type 2 diabetes.
The DPP and its follow-up, the DPP Outcomes Study (DPPOS), highlight the importance of lifestyle changes in managing prediabetes, particularly in a diverse population, suggesting that these interventions can be tailored to various ethnic backgrounds.
Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice.Hoskin, MA., Bray, GA., Hattaway, K., et al.[2019]
A randomized clinical trial involving 257 obese patients with metabolic syndrome showed that a group conference call (CC) intervention led to significantly greater weight loss (-5.6%) compared to individual calls (IC) (-1.8%) over 2 years, indicating that group support may enhance weight loss outcomes.
Participants in the CC group not only lost more weight but also continued to lose weight between the first and second year, while those in the IC group began to regain weight, highlighting the importance of ongoing support in lifestyle interventions.
Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study.Weinstock, RS., Trief, PM., Cibula, D., et al.[2022]
A 14-week intensive lifestyle intervention (ILI) program adapted from the Diabetes Prevention Program led to a significant weight loss of 3.8 kg (4.4%) in Hispanic women with prediabetes, while the usual care group gained weight.
The ILI group also showed improved metabolic measures, including a 15 mg/dL decrease in two-hour glucose levels and significant reductions in BMI, body fat percentage, waist circumference, and fasting insulin after one year.
Effective Translation of an Intensive Lifestyle Intervention for Hispanic Women With Prediabetes in a Community Health Center Setting.Van Name, MA., Camp, AW., Magenheimer, EA., et al.[2021]

References

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. [2019]
Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. [2022]
Effective Translation of an Intensive Lifestyle Intervention for Hispanic Women With Prediabetes in a Community Health Center Setting. [2021]
The Diabetes Prevention Program (DPP): description of lifestyle intervention. [2022]
The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results. [2018]
Sex differences in diabetes risk and the effect of intensive lifestyle modification in the Diabetes Prevention Program. [2022]
Lower-Intensity Interventions for Prediabetes: A Systematic Review. [2023]
Achieving weight and activity goals among diabetes prevention program lifestyle participants. [2022]