Trial Outcomes & Findings for A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer (NCT NCT01778127)

Last Updated: 2015-05-21

Results Overview

The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

105 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2015-05-21

Participant Flow

This protocol enrolled 105 participants at St. Jude Children's Research Hospital from 9/2013 through 4/2014. Of the 105, 5 were determined to be ineligible after baseline screening (4 too active; 1 did not meet IQ criteria), and 2 withdrew prior to randomization but after baseline testing. The remaining 98 were randomized.

98 participants were randomized 1:1:1 stratified by gender into 3 groups. Randomization was implemented using software based on Zelen's methodology. The principal investigator and study staff were blind to group assignment.

Participant milestones

Participant milestones
Measure	Group A: Minimal Rewards Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Group B: Immediate Incentives Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Group C: Control Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Overall Study STARTED	33	33	32
Overall Study COMPLETED	25	31	26
Overall Study NOT COMPLETED	8	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: Minimal Rewards Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Group B: Immediate Incentives Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Group C: Control Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Overall Study Lost to Follow-up	5	1	2
Overall Study Withdrawal by Subject	3	1	4

Baseline Characteristics

A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: Minimal Rewards n=25 Participants Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Group B: Immediate Incentives n=31 Participants Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Group C: Control n=26 Participants Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Total n=82 Participants Total of all reporting groups
Age, Continuous	13.0 years STANDARD_DEVIATION 1.2 • n=5 Participants	12.8 years STANDARD_DEVIATION 0.9 • n=7 Participants	12.6 years STANDARD_DEVIATION 1.2 • n=5 Participants	12.8 years STANDARD_DEVIATION 1.1 • n=4 Participants
Age, Customized Age at diagnosis	3.0 years STANDARD_DEVIATION 3.1 • n=5 Participants	4.2 years STANDARD_DEVIATION 3.0 • n=7 Participants	3.6 years STANDARD_DEVIATION 2.5 • n=5 Participants	3.6 years STANDARD_DEVIATION 2.9 • n=4 Participants
Age, Customized Time since diagnosis	10.0 years STANDARD_DEVIATION 3.0 • n=5 Participants	8.6 years STANDARD_DEVIATION 3.1 • n=7 Participants	9.0 years STANDARD_DEVIATION 2.7 • n=5 Participants	9.2 years STANDARD_DEVIATION 2.9 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	38 Participants n=4 Participants
Race/Ethnicity, Customized Non-White	3 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants	17 participants n=4 Participants
Race/Ethnicity, Customized White	22 participants n=5 Participants	25 participants n=7 Participants	18 participants n=5 Participants	65 participants n=4 Participants
Diagnosis Leukemia	5 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	19 participants n=4 Participants
Diagnosis Central Nervous System Tumor	7 participants n=5 Participants	7 participants n=7 Participants	4 participants n=5 Participants	18 participants n=4 Participants
Diagnosis Lymphoma	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	8 participants n=4 Participants
Diagnosis Retinoblastoma	6 participants n=5 Participants	5 participants n=7 Participants	2 participants n=5 Participants	13 participants n=4 Participants
Diagnosis Other Solid Tumor	5 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	24 participants n=4 Participants
Daily Moderate to Vigorous Physical Activity (MVPA)	26.8 minutes STANDARD_DEVIATION 15.7 • n=5 Participants	28.0 minutes STANDARD_DEVIATION 16.6 • n=7 Participants	32.3 minutes STANDARD_DEVIATION 22.6 • n=5 Participants	29.0 minutes STANDARD_DEVIATION 18.2 • n=4 Participants
Body mass index (BMI)	25.0 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants	22.6 kg/m^2 STANDARD_DEVIATION 6.3 • n=7 Participants	22.8 kg/m^2 STANDARD_DEVIATION 5.5 • n=5 Participants	23.4 kg/m^2 STANDARD_DEVIATION 6.1 • n=4 Participants
Resting heart rate (HR)	82.8 beats/minute STANDARD_DEVIATION 11.2 • n=5 Participants	80.4 beats/minute STANDARD_DEVIATION 14.5 • n=7 Participants	81.5 beats/minute STANDARD_DEVIATION 14.9 • n=5 Participants	81.5 beats/minute STANDARD_DEVIATION 13.6 • n=4 Participants
Resting respiratory rate (RR)	19.2 breaths/minute STANDARD_DEVIATION 1.1 • n=5 Participants	19.0 breaths/minute STANDARD_DEVIATION 1.3 • n=7 Participants	18.4 breaths/minute STANDARD_DEVIATION 1.7 • n=5 Participants	18.9 breaths/minute STANDARD_DEVIATION 1.4 • n=4 Participants
Blood pressure (BP) Systolic	115.6 mmHG STANDARD_DEVIATION 9.8 • n=5 Participants	113.5 mmHG STANDARD_DEVIATION 9.9 • n=7 Participants	117.6 mmHG STANDARD_DEVIATION 11.2 • n=5 Participants	115.4 mmHG STANDARD_DEVIATION 10.3 • n=4 Participants
Blood pressure (BP) Diastolic	68.2 mmHG STANDARD_DEVIATION 7.3 • n=5 Participants	66.2 mmHG STANDARD_DEVIATION 7.2 • n=7 Participants	68.5 mmHG STANDARD_DEVIATION 9.3 • n=5 Participants	67.5 mmHG STANDARD_DEVIATION 7.9 • n=4 Participants
Peak VO2	30.0 ml/kg/min STANDARD_DEVIATION 7.9 • n=5 Participants	30.0 ml/kg/min STANDARD_DEVIATION 7.8 • n=7 Participants	31.2 ml/kg/min STANDARD_DEVIATION 6.6 • n=5 Participants	30.4 ml/kg/min STANDARD_DEVIATION 7.5 • n=4 Participants
Sit and reach	21.7 cm STANDARD_DEVIATION 8.9 • n=5 Participants	19.6 cm STANDARD_DEVIATION 9.8 • n=7 Participants	22.2 cm STANDARD_DEVIATION 10.4 • n=5 Participants	21.1 cm STANDARD_DEVIATION 9.7 • n=4 Participants
Active dorsiflexion	13.1 degrees STANDARD_DEVIATION 7.6 • n=5 Participants	13.6 degrees STANDARD_DEVIATION 8.1 • n=7 Participants	14.3 degrees STANDARD_DEVIATION 8.6 • n=5 Participants	13.7 degrees STANDARD_DEVIATION 8.1 • n=4 Participants
Hand grip	20.9 kg STANDARD_DEVIATION 6.3 • n=5 Participants	19.0 kg STANDARD_DEVIATION 5.6 • n=7 Participants	22.5 kg STANDARD_DEVIATION 7.1 • n=5 Participants	20.7 kg STANDARD_DEVIATION 6.3 • n=4 Participants
Sit-up	14.3 sit-ups STANDARD_DEVIATION 5.1 • n=5 Participants	15.2 sit-ups STANDARD_DEVIATION 6.1 • n=7 Participants	16.2 sit-ups STANDARD_DEVIATION 6.2 • n=5 Participants	15.2 sit-ups STANDARD_DEVIATION 5.8 • n=4 Participants
Pushup	9.6 push-ups STANDARD_DEVIATION 6.6 • n=5 Participants	13.3 push-ups STANDARD_DEVIATION 5.9 • n=7 Participants	12.4 push-ups STANDARD_DEVIATION 7.5 • n=5 Participants	11.9 push-ups STANDARD_DEVIATION 6.6 • n=4 Participants
Quadriceps at 60 degrees/second	156.3 Newton meters (Nm)/kg STANDARD_DEVIATION 46.0 • n=5 Participants	164.2 Newton meters (Nm)/kg STANDARD_DEVIATION 46.3 • n=7 Participants	159.9 Newton meters (Nm)/kg STANDARD_DEVIATION 41.0 • n=5 Participants	160.4 Newton meters (Nm)/kg STANDARD_DEVIATION 44.5 • n=4 Participants
Quadriceps at 120 degrees/second	136.5 Newton meters (Nm)/kg STANDARD_DEVIATION 36.2 • n=5 Participants	142.0 Newton meters (Nm)/kg STANDARD_DEVIATION 41.7 • n=7 Participants	137.8 Newton meters (Nm)/kg STANDARD_DEVIATION 36.5 • n=5 Participants	139.0 Newton meters (Nm)/kg STANDARD_DEVIATION 38.4 • n=4 Participants
Quadriceps at 180 degrees/second	117.6 Newton meters (Nm)/kg STANDARD_DEVIATION 32.9 • n=5 Participants	121.7 Newton meters (Nm)/kg STANDARD_DEVIATION 36.7 • n=7 Participants	118.6 Newton meters (Nm)/kg STANDARD_DEVIATION 29.5 • n=5 Participants	119.4 Newton meters (Nm)/kg STANDARD_DEVIATION 33.3 • n=4 Participants
Dorsiflexion at 30 degrees/second	21.7 Nm/kg STANDARD_DEVIATION 8.7 • n=5 Participants	26.5 Nm/kg STANDARD_DEVIATION 14.9 • n=7 Participants	27.9 Nm/kg STANDARD_DEVIATION 15.0 • n=5 Participants	25.5 Nm/kg STANDARD_DEVIATION 13.0 • n=4 Participants
Dorsiflexion at 60 degrees/second	19.9 Nm/kg STANDARD_DEVIATION 7.4 • n=5 Participants	24.7 Nm/kg STANDARD_DEVIATION 12.0 • n=7 Participants	25.5 Nm/kg STANDARD_DEVIATION 11.1 • n=5 Participants	23.5 Nm/kg STANDARD_DEVIATION 10.3 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.