Trial Outcomes & Findings for TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women (NCT NCT04114071)

NCT ID: NCT04114071

Last Updated: 2023-09-08

Results Overview

number of steps

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2023-09-08

Participant Flow

Participant milestones

Measure	Physical Activity Intervention Group Older overweight or obese Black women who participate in the physical activity intervention group will receive a daily text message from the TOSS study for 12 weeks, a Fitbit device plus have access to the Fitbit community option on their Fitbit app as an opportunity for virtual peer support. They will also receive an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention. TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women: See arm description	Control Group The control will only receive a weekly neutral text message during the 12-week intervention. For this project, a neutral text message is defined as a message that only provides facts about a topic.They will also receive a Fitbit device, an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women: See arm description
Overall Study STARTED	15	15
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women

Baseline characteristics by cohort

Measure	Physical Activity Intervention Group n=15 Participants Older overweight or obese Black women who participate in the physical activity intervention group will receive a daily text message from the TOSS study for 12 weeks, a Fitbit device plus have access to the Fitbit community option on their Fitbit app as an opportunity for virtual peer support. They will also receive an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention. TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women: See arm description	Control Group n=15 Participants The control will only receive a weekly neutral text message during the 12-week intervention. For this project, a neutral text message is defined as a message that only provides facts about a topic.They will also receive a Fitbit device, an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women: See arm description	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	64.67 years n=5 Participants	65.33 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Body mass index	34.52 kg/m^2 STANDARD_DEVIATION 4.20 • n=5 Participants	35.33 kg/m^2 STANDARD_DEVIATION 5.95 • n=7 Participants	34.93 kg/m^2 STANDARD_DEVIATION 5.08 • n=5 Participants
hemoglobin A1c	6.18 percent of gylcosylated hemoglobin STANDARD_DEVIATION 2.18 • n=5 Participants	6.39 percent of gylcosylated hemoglobin STANDARD_DEVIATION 0.58 • n=7 Participants	6.29 percent of gylcosylated hemoglobin STANDARD_DEVIATION 1.57 • n=5 Participants
weight	209.7 lbs STANDARD_DEVIATION 32.76 • n=5 Participants	212.3 lbs STANDARD_DEVIATION 41.22 • n=7 Participants	211.02 lbs STANDARD_DEVIATION 36.61 • n=5 Participants
Steps per day	6207.85 Daily steps STANDARD_DEVIATION 4315.71 • n=5 Participants	6506.85 Daily steps STANDARD_DEVIATION 3480.18 • n=7 Participants	6357.35 Daily steps STANDARD_DEVIATION 3855.08 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

number of steps

Outcome measures

Measure	Physical Activity Intervention Group n=15 Participants Older overweight or obese Black women who participate in the physical activity intervention group will receive a daily text message from the TOSS study for 12 weeks, a Fitbit device plus have access to the Fitbit community option on their Fitbit app as an opportunity for virtual peer support. They will also receive an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention. TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women: See arm description	Control Group n=15 Participants The control will only receive a weekly neutral text message during the 12-week intervention. For this project, a neutral text message is defined as a message that only provides facts about a topic.They will also receive a Fitbit device, an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women: See arm description
Change in Physical Activity Behaviors From Baseline to 12 Weeks	-736.71 change in daily steps (baseline - post) Standard Deviation 4315.71	218.79 change in daily steps (baseline - post) Standard Deviation 3480.18

Adverse Events

Physical Activity Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Dr. Pamela G. Bowen

University of Alabama at Birmingham

Phone: 12059342778

Email: pbowen@uab.edu

Results disclosure agreements

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