Lifestyle Intervention + Stress Management for Obesity

(RESET Trial)

Overseen By Tiffany Carson, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Diabetes, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 4 months

341 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding stress management to a weight loss program aids weight loss for adult Black women experiencing obesity and high stress. Participants will join either a group focusing on weight loss with stress management (Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training) or a group focusing on weight loss with general health topics for women (Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics). The goal is to determine which approach more effectively helps participants lose weight. Ideal participants are Black women with a BMI of 30 or higher who frequently feel stressed. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to weight loss and stress management.

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 prior data suggests that this protocol is safe for participants?

Research has shown that the Diabetes Prevention Program (DPP) Intensive Lifestyle Intervention is generally safe and well-tolerated by participants. This program emphasizes lifestyle changes such as healthy eating and regular exercise. Studies have found that individuals following this program significantly reduce their risk of developing type 2 diabetes.

Regarding safety, these studies have not identified any major safety concerns or serious side effects associated with the program. Adding stress management training to this program has also proven to be safe.

The evidence supports that both the lifestyle program alone and the version with stress management are safe for individuals to try. No serious side effects have been reported, making it a promising option for those seeking to manage their weight and stress levels effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for obesity because they combine lifestyle changes with stress management techniques, offering a holistic approach to weight loss. Unlike traditional treatments that focus solely on diet and exercise, this approach adds stress management training, addressing the psychological factors that can contribute to obesity. By integrating stress management, the treatment aims to improve overall health and potentially enhance the effectiveness of weight loss efforts. This comprehensive strategy could lead to more sustainable results and improved well-being for individuals struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that the Diabetes Prevention Program (DPP) lifestyle intervention can help people lose weight and prevent diabetes. In past studies, participants in the DPP program lost at least 7% of their body weight and maintained the loss. The program also reduced the risk of developing type 2 diabetes by 58% over about three years. In this trial, one group will receive the standard DPP lifestyle intervention, which includes general women's health topics. Another group will receive a version of the program that incorporates stress management training to aid weight loss by addressing stress, which is linked to weight gain. Early results suggest that managing stress can enhance weight loss efforts, making this approach promising for those dealing with both obesity and high stress. ^{1 2 3 6 7}

Who Is on the Research Team?

Tiffany Carson, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
• Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

Trial Overview 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.

How Is the Trial Designed?

Group I: Weight Loss Plus Stress Management Experimental Treatment 1 Intervention

Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training

Group II: Weight Loss Only Active Control 1 Intervention

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

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+

Published Research Related to This Trial

In the Diabetes Prevention Program, 49% of participants achieved their initial weight loss goal, and 74% met their physical activity goal, but long-term success dropped to 37% for weight loss and 67% for activity after about 3.2 years.

Older participants were more likely to achieve long-term weight loss and activity goals, and those who practiced dietary self-monitoring had better success in both areas, indicating that initial success in these goals is a strong predictor of long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving weight and activity goals among diabetes prevention program lifestyle participants. Wing, RR., Hamman, RF., Bray, GA., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of 11 trials found that lower-intensity lifestyle interventions for prediabetes showed limited effectiveness, with only one high-quality study demonstrating a 3-kg weight reduction and a 0.2% decrease in HbA1c over 6 months.

The overall evidence for these lower-intensity interventions is weak, highlighting the need for more robust research to explore their potential in diabetes prevention, especially given the low participation in traditional, high-intensity programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-Intensity Interventions for Prediabetes: A Systematic Review. Tseng, E., Lam, KY., Meza, KA., et al.[2023]

The Diabetes Prevention Program (DPP) lifestyle intervention, involving 1,079 participants (45% racial and ethnic minorities), achieved a remarkable 58% reduction in diabetes incidence through targeted weight loss and physical activity goals.

Key features of the intervention included personalized coaching, frequent participant contact, a structured curriculum, and tailored strategies to accommodate ethnic diversity, all contributing to its effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program (DPP): description of lifestyle intervention. [2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. Weinstock, RS., Trief, PM., Cibula, D., et al.[2022]

Both the Diabetes Prevention Program (DPP) and the Healthy Living Partnerships to Prevent Diabetes (HELP PD) showed similar effectiveness in reducing body weight and blood glucose levels after 1 and 2 years, indicating that lifestyle interventions can be effective in different settings.

HELP PD participants experienced greater reductions in triglycerides compared to DPP participants, suggesting that community-based interventions may offer additional benefits in managing lipid levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results. Vitolins, MZ., Isom, SP., Blackwell, CS., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In the Diabetes Prevention Program, men showed greater improvements in diabetes risk factors with weight loss compared to women, particularly when losing more than 3% of body weight, indicating that intensive lifestyle modifications may have different effects based on sex.

Despite men having more unfavorable baseline risk factors for diabetes, both sexes had similar rates of diabetes incidence, suggesting that initial risk factors may mask the benefits of lifestyle changes in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in diabetes risk and the effect of intensive lifestyle modification in the Diabetes Prevention Program. Perreault, L., Ma, Y., Dagogo-Jack, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1282458/

The Diabetes Prevention Program (DPP) - PubMed Central The two major goals of the Diabetes Prevention Program (DPP) lifestyle intervention were a minimum of 7% weight loss/weight maintenance and a minimum of 150 min ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04335799

Reducing Weight and Elevated Stress Levels Using ... 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 ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa012512

Reduction in the Incidence of Type 2 Diabetes with ... The incidence of diabetes was reduced by 58 percent with the lifestyle intervention and by 31 percent with metformin, as compared with placebo.

4. icer.org icer.org/wp-content/uploads/2020/10/CTAF_DPP_Final_Evidence_Report_072516.pdf

Diabetes Prevention Programs: Effectiveness and Value The Diabetes Prevention Program Trial (DPP Trial) demonstrated that the incidence of diabetes could be reduced using intensive diet and lifestyle counseling for ...

5. niddk.nih.gov niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp

Diabetes Prevention Program (DPP) - NIDDK After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00004992

Study Details | NCT00004992 | Diabetes Prevention Program Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes.

7. cdc.gov cdc.gov/pcd/issues/2024/24_0173.htm

Moving Diabetes Prevention Programs to the Workplace The DPP lifestyle change program consists of weekly classes for 2 months, semiweekly classes for 4 months, then monthly classes for 6 months for ...