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

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

358 Participants Needed

Trial Summary

What is the purpose of this trial?

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 to see if diet and exercise can help people lose weight and improve other health problems. This two year study will compare two methods of informing participants about ways to lose weight.

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 data supports the effectiveness of this treatment for weight loss in survivors of childhood leukemia?

Research shows that nutrition counseling and lifestyle interventions can help manage weight gain in children with acute lymphoblastic leukemia (ALL). Studies found that early nutrition interventions and lifestyle coaching can lead to healthier eating habits and more controlled weight gain during and after treatment. ^{1 2 3 4 5}

Is diet and exercise counseling safe for childhood leukemia survivors?

Research on diet and exercise counseling for childhood leukemia survivors suggests it is generally safe. Studies have shown that these interventions can help manage weight and improve dietary habits without significant adverse effects. ^{1 2 4 6 7}

How does the self-directed weight loss treatment differ from other treatments for weight management in childhood leukemia survivors?

This treatment is unique because it focuses on self-directed diet and exercise counseling, empowering survivors of childhood leukemia to manage their weight through lifestyle changes rather than relying on medication. It emphasizes personal responsibility and education, which can lead to sustainable long-term health benefits. ^{1 2 4 6 8}

Research Team

Chaya Moskowitz, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

A body mass index (BMI) ≥ 25 kg/m2 (overweight or obese), as determined by self-reported height and weight on the most recent CCSS questionnaire

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized nutrition counseling intervention in pediatric leukemia patients receiving steroids results in reduced caloric intake. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Early Lifestyle Intervention for Obesity Prevention in Pediatric Survivors of Acute Lymphoblastic Leukemia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Early Nutrition Intervention Attenuates Weight Gain for Pediatric Acute Lymphoblastic Leukemia Patients in Maintenance Therapy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A cross-sectional study of overweight in pediatric survivors of acute lymphoblastic leukemia (ALL). [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Fitness of children with standard-risk acute lymphoblastic leukemia during maintenance therapy: response to a home-based exercise and nutrition program. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Physical Activity in Long-term Survivors of Acute Lymphoblastic Leukemia in Childhood and Adolescence: A Cross-sectional Cohort Study. [2018]

8. United States 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. [2021]