Trial Outcomes & Findings for eHealth Weight Loss Program in African American Breast Cancer Survivors (NCT NCT02699983)

NCT ID: NCT02699983

Last Updated: 2021-04-13

Results Overview

Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as \>= 75% recruitment rate.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2021-04-13

Participant Flow

Participant milestones

Measure	Group I (SparkPeople Program) Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. Activity Monitoring Device: Wear Fitbit activity monitoring device
Overall Study STARTED	18	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Group I (SparkPeople Program) Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. Activity Monitoring Device: Wear Fitbit activity monitoring device
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

eHealth Weight Loss Program in African American Breast Cancer Survivors

Baseline characteristics by cohort

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.	Total n=35 Participants Total of all reporting groups
Age, Continuous	61.20 years STANDARD_DEVIATION 10.26 • n=93 Participants	62.25 years STANDARD_DEVIATION 6.66 • n=4 Participants	61.67 years STANDARD_DEVIATION 8.74 • n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	17 Participants n=4 Participants	35 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants	17 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	18 Participants n=93 Participants	17 Participants n=4 Participants	35 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	18 participants n=93 Participants	17 participants n=4 Participants	35 participants n=27 Participants
BMI	35.51 kg/m^2 STANDARD_DEVIATION 6.98 • n=93 Participants	38.40 kg/m^2 STANDARD_DEVIATION 6.94 • n=4 Participants	36.73 kg/m^2 STANDARD_DEVIATION 6.84 • n=27 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The overall number of participants is the number that were eligible for the study, hence it is greater than the number with results.

Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.

Outcome measures

Measure	Group I (SparkPeople Program) n=23 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=22 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Recruitment Rate	18 Participants	17 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants completing study. Feasibility will be defined as >= 80% retention rate.

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Retention Rate	17 Participants	17 Participants

PRIMARY outcome

Timeframe: 0-3 months after intervention

average number of days logged per week in to SparkPeople website

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Adherence to SparkPeople- Logged in	3.01 days/week Standard Deviation 2.07	2.30 days/week Standard Deviation 2.27

PRIMARY outcome

Timeframe: 4-6 months after intervention

Average number of days per week logged in to SparkPeople website

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Adherence to SparkPeople- Logged in	2.30 days/week Standard Deviation 2.30	1.14 days/week Standard Deviation 1.64

PRIMARY outcome

Timeframe: 0-3 months after intervention

Average number of days per week logged food into SparkPeople

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Adherence to SparkPeople- Logged Food	1.69 days/week Standard Deviation 1.84	1.50 days/week Standard Deviation 1.85

PRIMARY outcome

Timeframe: 4-6 months after intervention

Average number of days per week logged food into SparkPeople

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Adherence to SparkPeople- Logged Food	0.6 days/week Standard Deviation 0.87	0.71 days/week Standard Deviation 1.17

PRIMARY outcome

Timeframe: 0-3 months after intervention

Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Acceptability of SparkPeople	3.53 score on a scale Standard Deviation 0.83	3.60 score on a scale Standard Deviation 0.52

PRIMARY outcome

Timeframe: 4-6 months after intervention

Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Acceptability of SparkPeople	3.53 score on a scale Standard Deviation 0.80	3.42 score on a scale Standard Deviation 0.79

PRIMARY outcome

Timeframe: 0-3 months after intervention

average days used Fitbit per week

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Adherence to Fitbit	6.24 days/week Standard Deviation 0.84	5.96 days/week Standard Deviation 1.63

PRIMARY outcome

Timeframe: 4-6 months after intervention

average days used Fitbit per week

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Adherence to Fitbit	5.57 days/week Standard Deviation 1.83	5.61 days/week Standard Deviation 1.77

PRIMARY outcome

Timeframe: 0-3 months after intervention

Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Acceptability of Fitbit	3.93 score on a scale Standard Deviation 0.26	3.93 score on a scale Standard Deviation 0.26

PRIMARY outcome

Timeframe: 4-6 months after intervention

Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Acceptability of Fitbit	4.00 score on a scale Standard Deviation 0	4.00 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: baseline and 3 months

Change in weight from baseline

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Weight	-2.10 kg Standard Deviation 2.64	-2.26 kg Standard Deviation 2.16

SECONDARY outcome

Timeframe: baseline and 6 months

Change in weight from baseline

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Weight	-1.71 kg Standard Deviation 1.88	-2.53 kg Standard Deviation 4.00

SECONDARY outcome

Timeframe: baseline and 3 months

Change in waist circumference from baseline

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Waist Circumference	-1.98 cm Standard Deviation 5.39	-0.05 cm Standard Deviation 5.56

SECONDARY outcome

Timeframe: baseline and 6 months

Change in waist circumference from baseline

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Waist Circumference	-3.56 cm Standard Deviation 4.70	-0.84 cm Standard Deviation 5.21

SECONDARY outcome

Timeframe: baseline and 3 months

Changes in caloric intake per day, measured by 24-hour recall

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Caloric Intake	-62.06 kcal/day Standard Deviation 589.27	-386.38 kcal/day Standard Deviation 514.95

SECONDARY outcome

Timeframe: baseline and 6 months

Changes in caloric intake per day, measured by 24-hour recall

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Caloric Intake	-216.65 kcal/day Standard Deviation 606.09	-173.06 kcal/day Standard Deviation 805.40

SECONDARY outcome

Timeframe: baseline and 3 months

change in average number of steps per day measured using Fitbit monitor

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Physical Activity	466.36 steps per day Standard Deviation 2203.49	-609.83 steps per day Standard Deviation 2898.36

SECONDARY outcome

Timeframe: baseline and 6 months

change in average number of steps per day measured using Fitbit monitor

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Physical Activity	-107.07 steps per day Standard Deviation 2184.94	-205.47 steps per day Standard Deviation 2147.79

SECONDARY outcome

Timeframe: baseline and 3 months

change in fitness, measured by the 6-minute walk test

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Cardiopulmonary Fitness	0.81 meters Standard Deviation 51.13	20.07 meters Standard Deviation 52.81

SECONDARY outcome

Timeframe: baseline and 6 months

change in fitness, measured by the 6-minute walk test

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Cardiopulmonary Fitness	26.64 meters Standard Deviation 35.88	31.97 meters Standard Deviation 26.27

SECONDARY outcome

Timeframe: baseline and 3 months

measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Quality of Life	-5.44 units on a scale Standard Deviation 18.11	-4.35 units on a scale Standard Deviation 16.69

SECONDARY outcome

Timeframe: baseline and 6 months

measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Change in Quality of Life	-9.44 units on a scale Standard Deviation 16.97	-4.65 units on a scale Standard Deviation 24.21

SECONDARY outcome

Timeframe: baseline and 3 months

change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Self-efficacy, Eating Healthy Foods	2.14 units on a scale Standard Deviation 8.17	-0.41 units on a scale Standard Deviation 13.47

SECONDARY outcome

Timeframe: baseline and 6 months

change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Self-efficacy, Eating Healthy Foods	5.59 units on a scale Standard Deviation 12.63	-6.59 units on a scale Standard Deviation 15.36

SECONDARY outcome

Timeframe: baseline and 3 months

change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Social Support for Healthy Nutrition	0.40 units on a scale Standard Deviation 0.58	0.11 units on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: baseline and 6 months

change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome

Outcome measures

Measure	Group I (SparkPeople Program) n=18 Participants Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. Behavioral Dietary Intervention: Use SparkPeople web-based program Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program Activity Monitoring Device: Wear Fitbit activity monitoring device	Group II (Wait List) n=17 Participants Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment. Exercise Intervention: Use Fitbit monitor Activity Monitoring Device: Wear Fitbit activity monitoring device
Social Support for Healthy Nutrition	0.39 units on a scale Standard Deviation 0.85	0.11 units on a scale Standard Deviation 0.71

Adverse Events

Group I (SparkPeople Program)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group II (Wait List)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeanne Ferrante

Rutgers Robert Wood Johnson Medical School

Phone: 848-932-5252

Email: jeanne.ferrante@rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place