Weight-Loss Program for Lowering Breast Cancer Risk in Obesity

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Oral antidiabetics, GLP-1 agonists

Disqualifiers: Type 1 diabetes, Type 2 diabetes, Cancer treatment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a diabetes prevention program, with or without additional hunger training, can help reduce breast cancer risk in people with obesity. The Diabetes Prevention Program teaches weight loss strategies, while hunger training helps participants recognize true hunger. The trial aims to determine if these methods can effectively control weight and potentially lower cancer risk. Individuals with a BMI of 27 or higher who are at high risk of developing breast cancer may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new preventive strategies for breast cancer.

Will I have to stop taking my current medications?

The trial requires that you do not use oral antidiabetic agents (except metformin) and certain other medications that could interfere with glucose metabolism. If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Diabetes Prevention Program (DPP) is safe and well-received. Studies have found that this program can help people lose 5 to 7 percent of their body weight, reducing the risk of type 2 diabetes. The program involves simple changes like regular exercise and healthier eating, which are generally safe for most people.

Early results suggest that hunger training is also safe and effective. This method teaches people to eat only when truly hungry, aiding in weight loss. Participants in hunger training studies reported losing weight without serious side effects.

Overall, both the DPP and hunger training have been tested for safety with positive outcomes. They focus on lifestyle changes instead of medication, which usually means fewer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a structured weight-loss program could lower breast cancer risk in individuals with obesity. The study uses the Diabetes Prevention Program (DPP), which focuses on lifestyle changes like diet and exercise to achieve weight loss. What makes it particularly interesting is the addition of "hunger training" in one of the experimental groups. This method aims to teach participants how to better understand and manage their hunger cues, potentially enhancing the effectiveness of the traditional DPP. Unlike standard care options that might involve medication or surgery, this approach emphasizes sustainable lifestyle changes that could not only aid in weight loss but also reduce cancer risk.

What evidence suggests that this trial's treatments could be effective for lowering breast cancer risk in obesity?

Research has shown that the Diabetes Prevention Program (DPP), which participants in Group A of this trial will follow, helps people lose weight and lower their risk of developing type 2 diabetes by 58%. Participants typically lose about 5% to 7% of their body weight. This weight loss is linked to better health, including a possible reduction in cancer risk. In Group B of this trial, participants will follow the DPP and also engage in hunger training. Recognizing true hunger, known as hunger training, might lead to greater weight loss than typical programs. Early studies suggest that losing more than 10% of body weight can positively impact factors related to breast cancer risk. ^{2 3 5 6 7}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for obese individuals at high risk of developing breast cancer, which includes those with a BMI >= 27 kg/m^2, history of certain breast conditions or BRCA1/2 mutations. Participants must have had no menstrual cycle for 12 months or undergone bilateral oophorectomy, be proficient in English, and able to take digital photos. Those actively treated for cancer (except nonmelanoma skin cancer), with diabetes or using specific glucose-affecting drugs cannot join.

Inclusion Criteria

I am at high risk for breast cancer due to genetic factors or previous conditions.

Internet access (daily)

Proficient in English (can read/write and speak fluently)

Exclusion Criteria

I am taking medication for diabetes in pill form.

I am not taking any medication that affects blood sugar, except possibly metformin.

I am currently receiving treatment for a cancer that is not nonmelanoma skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take part in the Diabetes Prevention Program (DPP) once a week over 1 hour for 16 weeks. Group B also receives hunger training once a week during weeks 2-6.

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for changes in weight, metabolic and breast cancer risk biomarkers, and behavioral mediators.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Prevention Program
• Hunger Training

Trial Overview The study is testing whether adding hunger training to a diabetes prevention program helps obese participants control their weight better and thus reduce the risk of breast cancer. Hunger training teaches how to recognize true hunger cues. The effectiveness will be compared between those who only receive the diabetes prevention program and those who also get hunger training.

How Is the Trial Designed?

Group I: Group B (DPP-HT) Experimental Treatment 2 Interventions

Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.

Group II: Group A (DPP) Active Control 2 Interventions

Participants take part in DPP once a week over 1 hour for 16 weeks.

Diabetes Prevention Program is already approved in United States for the following indications:

Approved in United States as National Diabetes Prevention Program (NDPP) for:

• Prediabetes
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

The Diabetes Prevention Program (DPP) can reduce the incidence of diabetes by 58% over three years for individuals with prediabetes, yet most patients are unaware of their condition.

With Medicare coverage starting in 2018, the DPP has become more accessible for patients over 65, highlighting the need for healthcare providers to implement screening and referral processes for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. Jasik, CB., Joy, E., Brunisholz, KD., et al.[2019]

The Diabetes Prevention Program (DPP) is a large clinical trial involving 3,234 participants aimed at evaluating interventions to prevent type 2 diabetes in individuals at high risk, with a diverse demographic including various ethnic backgrounds and age groups.

The study will assess the effectiveness of three treatment approaches: intensive lifestyle modification, standard care with metformin, and standard care with placebo, to determine their impact on delaying or preventing diabetes development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

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 a study of 1,007 participants in the National Diabetes Prevention Program, individuals lost an average of 4% of their initial body weight, with about one-third achieving over 5% weight loss, indicating the program's overall efficacy in promoting weight loss.

After controlling for program attendance and physical activity, no significant disparities in weight loss outcomes were found among different demographic groups, although lower attendance and physical activity levels were noted in non-Hispanic Black and Hispanic participants, suggesting a need for targeted strategies to enhance their engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Disparities Among Hispanic and Underserved Participants, Colorado, 2015-2018. Clennin, MN., Maytag, A., Ellis, J., et al.[2021]

In a modified Diabetes Prevention Program (DPP) for patients with non-alcoholic fatty liver disease (NAFLD), 79% of participants completed the program, leading to significant weight loss and improvements in liver health indicators over 12 months.

Key improvements included reduced hepatic steatosis and liver enzymes, indicating enhanced liver function, although there was a noted increase in low-density lipoprotein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Hershman, M., Torbjornsen, K., Pang, D., et al.[2023]

Citations

1. 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 ...

2. cdc.gov cdc.gov/diabetes-prevention/programs/what-is-the-national-dpp.html

What Is the National DPP? | National Diabetes Prevention ... Results from the study showed that this structured lifestyle change program—in which participants achieved weight loss of 5 to 7 percent of ...

3. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(25)00400-9/fulltext

results from the diabetes prevention program outcomes study There were 403 incident lifestyle-related cancer cases. Scores improved after 1 and 15 y (mean increase = 0.43 and 0.27 points, respectively, both P < 0.001).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2677576/

Physical Activity, Weight Control, and Breast Cancer Risk and ... The trial goal for women whose BMI is greater than 25 kg/m2 is to lose 10% of body weight. In addition to this individual goal of 10% weight loss, the overall ...

5. diabetes.org diabetes.org/about-diabetes/diabetes-prevention/dpp

Learn About the National Diabetes Prevention Program Find a Diabetes Prevention Program near you, a healthy lifestyle change program proven to prevent or delay type 2 diabetes.

6. cdc.gov cdc.gov/diabetes-prevention/index.html

National Diabetes Prevention Program The National Diabetes Prevention Program is building a nationwide network for its lifestyle change program, which is proven to cut type 2 diabetes risk in half.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05640869

Diabetes Prevention Program to Treat Overweight and ... The purpose of this study is to demonstrate the efficacy of the diabetes prevention program for the treatment of overweight and obesity within the community ...