Diet & Exercise Counseling for Weight Loss in Survivors of Childhood Leukemia

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Weight loss medications

Disqualifiers: Heart disease, Stroke, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist adult survivors of childhood acute lymphoblastic leukemia (ALL) who are currently overweight or obese. Researchers seek to determine if diet and exercise counseling can aid in weight loss and improve overall health. Participants will either work with a diet and exercise counselor online or receive general health information. Those who have survived childhood ALL, are cancer-free, and have a BMI of 25 or higher (indicating they are overweight) might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance health outcomes for others in similar situations.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using prescription weight loss medication, you must have stopped it at least 6 months before joining the study.

What prior data suggests that these methods are safe for weight loss in survivors of childhood leukemia?

Research shows that diet and exercise counseling is generally safe for children who have survived leukemia. Studies have found that these programs can help individuals lose weight without harm. In trials with adults who survived childhood acute lymphoblastic leukemia (ALL), participants followed diet and exercise plans for two years. These studies did not report any serious side effects from the programs. Instead, participants successfully lost weight with counselors' support. Overall, diet and exercise counseling appears to be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a personalized approach to weight loss for survivors of childhood leukemia, which isn't typically offered in standard care. Unlike general advice or printed materials, participants in the intervention group receive tailored guidance through a dedicated diet and physical activity counselor. This counselor supports participants via a digital platform, making the process more interactive and adaptable. Additionally, the focus on gradually increasing physical activity and tracking progress online is designed to fit into participants' lifestyles, potentially leading to more sustainable weight loss outcomes.

What evidence suggests that diet and exercise counseling could be effective for weight loss in survivors of childhood leukemia?

Research has shown that diet and exercise counseling can help manage weight gain in childhood leukemia survivors. In this trial, participants in the intervention group will receive support from an individual diet and physical activity counselor through Healthways at Hopkins. Although some studies did not show significant weight loss in these survivors, they succeeded in other groups, such as those with heart conditions. In similar studies, individuals with a counselor lost an average of 2.75 kg more than those who attempted weight loss independently. This suggests that having a counselor for diet and exercise might be more effective than trying to lose weight alone. Overall, lifestyle changes like these are generally safe and helpful for managing weight. ^{1 2 3 6 7}

Who Is on the Research Team?

Chaya Moskowitz, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

The EQUAL study is for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are now overweight or obese. Participants must be at least 18 years old, have a BMI of 25 or higher, internet access with an email account, and be cancer-free at enrollment. They can't join if they've had total body irradiation, conditions where weight loss isn't advised, used weight loss meds recently, or have certain heart diseases.

Inclusion Criteria

I was diagnosed with leukemia before turning 18.

I am currently free of cancer.

Eligibility will be confirmed via the CCSS-based medical record and by a series of questions on the EQUAL website, prior to consent

Exclusion Criteria

I am not pregnant and do not have a condition like anorexia or bulimia that affects my weight.

I have undergone total body irradiation.

I have not used prescription weight loss drugs in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive individualized diet and physical activity counseling through Healthways at Hopkins for 24 months

24 months

Primary communication via website & email

Control

Participants receive general information brochures on healthy living and weight loss

24 months

Follow-up

Participants are monitored for weight loss and health improvements

24 months

Weight measured at 0, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• individual diet & physical activity counselor and website through Healthways at Hopkins
• questionnaires
• self directed weight loss

Trial Overview This study tests whether diet and exercise guidance helps adult survivors of childhood ALL lose weight and improve health. Over two years, it compares personalized counseling with website support against self-directed weight loss efforts using questionnaires and health measurements.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 3 Interventions

Participants will be assigned an individual diet \& physical activity counselor through Healthways at Hopkins. This counselor will stay with the participant for the 24 months. The primary communication with the counselor will be via website \& email. Participants will be encouraged to consume a low-calorie, low-salt diet with 7-12 daily servings of fruits, vegetables \& low-fat dairy products. Calorie goals are based upon weight at study entry \& whether or not the weight loss goal has been met. Participants will gradually build to ≥ 180 minutes of moderate to vigorous physical activity per week, using the activity of their own choosing \& gradually adding bouts of ≥ 10 minutes in length. Monitoring \& Counselor Contacts: the first 3 months, the participants are encouraged to log into the web hub on a daily basis to record weight, food intake, \& physical activity. Participants who decline or drop out of the intervention program will remain on-study doing home visits \& questionnaires.

Group II: control group Active Control 3 Interventions

Participants will receive general information brochures on healthy living and weight loss but will not have access to the Healthways at Hopkins website or counselors.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

St. Jude Children's Research Hospital

Collaborator

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

A pilot study involving 17 children aged 5 to 10 years with acute lymphoblastic leukemia showed that a 6-month home-based exercise intervention was feasible, with 71% of participants completing the program.

The exercise intervention led to significant improvements in physical abilities, including strength and flexibility, with 67% of participants showing enhanced knee strength and 83% improving ankle flexibility, indicating potential benefits for children undergoing cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. Esbenshade, AJ., Friedman, DL., Smith, WA., et al.[2022]

A 12-week remote lifestyle intervention for 15 children with pediatric acute lymphoblastic leukemia (ALL) showed promising results, with 86.7% of families completing the program.

The intervention led to positive dietary changes, such as increased milk and protein intake and reduced consumption of potatoes, although it did not significantly affect physical activity levels, BMI, or waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Lifestyle Intervention for Obesity Prevention in Pediatric Survivors of Acute Lymphoblastic Leukemia. Zhang, FF., Kelly, M., Du, M., et al.[2020]

A lifestyle intervention involving diet and physical activity led to significant weight loss (5.6 kg) and improvements in body composition among 37 overweight and obese breast cancer survivors who completed the program.

Participants showed substantial reductions in energy and fat intake, along with improvements in quality of life and cardiorespiratory fitness, indicating the intervention's effectiveness in promoting healthier lifestyles post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. Travier, N., Fonseca-Nunes, A., Javierre, C., et al.[2021]

A 3-visit nutrition intervention for pediatric patients with acute lymphoblastic leukemia (ALL) significantly controlled weight gain during maintenance therapy, as shown in a study of 67 patients (33 intervention, 34 control).

The intervention was particularly effective in managing weight gain trends, even after accounting for factors like initial BMI and weight changes during intensive therapy, indicating its potential as a modifiable strategy to combat obesity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Nutrition Intervention Attenuates Weight Gain for Pediatric Acute Lymphoblastic Leukemia Patients in Maintenance Therapy. Hill, R., Hamby, T., Bashore, L., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11371536/

A randomized weight loss trial among adult survivors ... A remote weight-loss intervention that was successful among adults with CV conditions did not result in significant weight loss among adult survivors of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02244411

NCT02244411 | Exercise and QUality Diet After Leukemia ... The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are overweight or obese. The purpose of this study is ...

3. ccss.stjude.org ccss.stjude.org/content/dam/en_US/shared/ccss/documents/concept-prop/concept-proposal%2023-08_2023-04-19T16_14_21.pdf

Exercise and QUality diet After Leukemia ... study will be assigned an individual diet and physical activity counselor through Healthways at Hopkins. This counselor will stay with the participant for ...

4. withpower.com withpower.com/trial/phase-leukemia-8-2014-f0c64

Diet & Exercise Counseling for Weight Loss in Survivors of ... Research on diet and exercise counseling for childhood leukemia survivors suggests it is generally safe. Studies have shown that these interventions can help ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38652494/

A Randomized Weight Loss Trial among Adult Survivors of ... We tested a remote weight-loss intervention trial that was effective among adults with CV risk factors in a cohort of adult survivors of ...

6. researchgate.net researchgate.net/publication/380032931_Exercise_and_QUality_Diet_after_Leukemia_A_Randomized_Weight_Loss_Trial_among_Adult_Survivors_of_Childhood_Leukemia_in_the_Childhood_Cancer_Survivor_Study

A Randomized Weight Loss Trial among Adult Survivors of ... Another trial enrolled 274 PCSs in a fully remote diet and exercise intervention consisting of a ≥5% daily calorie restriction and ≥180 min of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07042932

Online Physical Activity and Health Counseling for ... Study Overview. Advances in the medical treatment of childhood acute lymphoblastic leukemia (ALL) have resulted in 5-year survival rates above 90%- however, ...