Trial Outcomes & Findings for Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL) (NCT NCT02708108)
NCT ID: NCT02708108
Last Updated: 2023-03-28
Results Overview
Assessment of change in fat before and after the induction chemotherapy phase (first 28 days of chemotherapy) as measured dual-energy x-ray absorptiometry (DXA) in comparison to fat gain in a recent historical cohort. Calculated as (Day 28 Fat Mass - Diagnosis Fat Mass)/Diagnosis Fat Mass
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Diagnosis and 28-35 days
Results posted on
2023-03-28
Participant Flow
A non-prospective, historical cohort was used as a comparison group for this single-arm study.
Participant milestones
| Measure |
Obesity Intervention
Diet: 10% caloric deficit, protein \>= 20% calories, fat \<25% calories, carbohydrate \<55% calories, low glycemic load \<100/2000 kcal.
Activity: 200 minutes/week of aerobic and resistance training
Duration 28 days
|
Historical Control
Previous, consecutively treated unselected patients with B-ALL without the IDEAL intervention
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
83
|
|
Overall Study
COMPLETED
|
38
|
80
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Obesity Intervention
Diet: 10% caloric deficit, protein \>= 20% calories, fat \<25% calories, carbohydrate \<55% calories, low glycemic load \<100/2000 kcal.
Activity: 200 minutes/week of aerobic and resistance training
Duration 28 days
|
Historical Control
Previous, consecutively treated unselected patients with B-ALL without the IDEAL intervention
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Regimen change
|
1
|
0
|
|
Overall Study
No MRD and no imaging available
|
0
|
1
|
Baseline Characteristics
Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
Baseline characteristics by cohort
| Measure |
Obesity Intervention
n=40 Participants
Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance.
Dietary Intervention: Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.
Activity and Exercise Intervention: Beginning at the time of diagnosis, the exercise and activity component uses an "activity menu" to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy.
|
Historical Control
n=80 Participants
Historical control assembled from previous, unselected, consecutive patients treated for B-ALL matching eligibility criteria.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.0 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
14.80 years
STANDARD_DEVIATION 2.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
80 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
BMI Category
Lean
|
14 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
BMI Category
Overweight
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
BMI Category
Obese
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Diagnosis and 28-35 daysPopulation: Includes enrolled (or from historical control) with imaging information via DXA scan.
Assessment of change in fat before and after the induction chemotherapy phase (first 28 days of chemotherapy) as measured dual-energy x-ray absorptiometry (DXA) in comparison to fat gain in a recent historical cohort. Calculated as (Day 28 Fat Mass - Diagnosis Fat Mass)/Diagnosis Fat Mass
Outcome measures
| Measure |
Obesity Intervention
n=36 Participants
Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance.
Dietary Intervention: Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.
Activity and Exercise Intervention: Beginning at the time of diagnosis, the exercise and activity component uses an "activity menu" to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy.
|
Historical Control
n=36 Participants
Historical control assembled from previous, unselected, consecutive patients treated for B-ALL matching eligibility criteria.
|
|---|---|---|
|
Fat Mass
|
5.1 percent change in fat mass
Interval -0.7 to 15.13
|
10.7 percent change in fat mass
Interval 3.29 to 19.28
|
SECONDARY outcome
Timeframe: 28-35 days from diagnosisCompare the rate of minimal residual disease "positivity" (defined as \>=0.01%) in the bone marrow by flow cytometry after the induction phase of chemotherapy as compared to a recent historical cohort
Outcome measures
| Measure |
Obesity Intervention
n=38 Participants
Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance.
Dietary Intervention: Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.
Activity and Exercise Intervention: Beginning at the time of diagnosis, the exercise and activity component uses an "activity menu" to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy.
|
Historical Control
n=80 Participants
Historical control assembled from previous, unselected, consecutive patients treated for B-ALL matching eligibility criteria.
|
|---|---|---|
|
Percentage of Participants With Minimal Residual Disease >=0.01%
|
12 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: A total of 392 visits with the PT or RD were expected to be completed as part of the the study intervention.
Assess feasibility of incorporating the intervention into induction chemotherapy as defined by \>80% of overall scheduled study visits successfully completed. The expected number of overall visits is equal to the sum of total visits scheduled with the physiotherapist (PT) or the registered dietitian (RD). The measure was calculated as the total # expected visits/completed visits.
Outcome measures
| Measure |
Obesity Intervention
n=392 Visits
Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance.
Dietary Intervention: Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.
Activity and Exercise Intervention: Beginning at the time of diagnosis, the exercise and activity component uses an "activity menu" to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy.
|
Historical Control
Historical control assembled from previous, unselected, consecutive patients treated for B-ALL matching eligibility criteria.
|
|---|---|---|
|
Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist
|
339 Visits
|
—
|
SECONDARY outcome
Timeframe: 28 daysOverall adherence to the study intervention was calculated as the mean of dietary adherence (average of percent consumed calories/prescribed calories for each food group) and activity (self-reported % adherence to prescribed days).
Outcome measures
| Measure |
Obesity Intervention
n=39 Participants
Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance.
Dietary Intervention: Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.
Activity and Exercise Intervention: Beginning at the time of diagnosis, the exercise and activity component uses an "activity menu" to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy.
|
Historical Control
Historical control assembled from previous, unselected, consecutive patients treated for B-ALL matching eligibility criteria.
|
|---|---|---|
|
Percentage of Overall Adherence to the IDEAL Intervention
|
82.1 % adherence
Interval 77.7 to 86.5
|
—
|
Adverse Events
Obesity Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Historical Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place