Trial Outcomes & Findings for Exercise and QUality Diet After Leukemia: The EQUAL Study (NCT NCT02244411)
NCT ID: NCT02244411
Last Updated: 2026-07-24
Results Overview
Weight loss will be evaluated in an intent-to-treat analysis with a linear mixed effects model with robust standard errors and an unstructured covariance matrix(50) using weight measured as the outcome modeled as a function of time, randomization arm, a history of CRT, gender, age, and race together with interaction terms between time and randomization arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
358 participants
Primary outcome timeframe
24 months
Results posted on
2026-07-24
Participant Flow
Participant milestones
| Measure |
Intervention Group
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.
|
Control Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
177
|
|
Overall Study
COMPLETED
|
165
|
170
|
|
Overall Study
NOT COMPLETED
|
16
|
7
|
Reasons for withdrawal
| Measure |
Intervention Group
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.
|
Control Group
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
7
|
Baseline Characteristics
Exercise and QUality Diet After Leukemia: The EQUAL Study
Baseline characteristics by cohort
| Measure |
Intervention Group
n=181 Participants
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.
|
Control Group
n=177 Participants
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.
|
Total
n=358 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
n=9 Participants
|
38 years
n=27 Participants
|
37.5 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=9 Participants
|
102 Participants
n=27 Participants
|
210 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=9 Participants
|
75 Participants
n=27 Participants
|
148 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
179 Participants
n=9 Participants
|
173 Participants
n=27 Participants
|
352 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
162 Participants
n=9 Participants
|
164 Participants
n=27 Participants
|
326 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
181 Participants
n=9 Participants
|
177 Participants
n=27 Participants
|
358 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 24 monthsWeight loss will be evaluated in an intent-to-treat analysis with a linear mixed effects model with robust standard errors and an unstructured covariance matrix(50) using weight measured as the outcome modeled as a function of time, randomization arm, a history of CRT, gender, age, and race together with interaction terms between time and randomization arm.
Outcome measures
| Measure |
Intervention Group
n=181 Participants
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.
|
Control Group
n=177 Participants
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.
|
|---|---|---|
|
Weight Loss
|
-0.36 kg
Standard Error 0.78
|
0.18 kg
Standard Error 0.66
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intervention Group
n=181 participants at risk
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.
|
Control Group
n=177 participants at risk
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.
|
|---|---|---|
|
General disorders
Death NOS
|
0.00%
0/181 • 24 months
|
0.56%
1/177 • 24 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chaya Moskowitz, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-227-3607
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place