Trial Outcomes & Findings for Reducing Metabolic Syndrome Among Breast Cancer Survivors (NCT NCT03719677)
NCT ID: NCT03719677
Last Updated: 2020-11-20
Results Overview
Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
From week 0-2
Results posted on
2020-11-20
Participant Flow
Participant milestones
| Measure |
Habit Development Intervention
Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.
Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Metabolic Syndrome Among Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Habit Development Intervention
n=7 Participants
Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.
Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
|
|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From week 0-2Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
Outcome measures
| Measure |
Habit Development Intervention
n=7 Participants
Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.
Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
|
|---|---|
|
Self Reported Behavioral Automaticity Index
Baseline
|
1.6 score on a scale
Standard Deviation 1.3
|
|
Self Reported Behavioral Automaticity Index
Post test
|
4.8 score on a scale
Standard Deviation 2.1
|
Adverse Events
Habit Development Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place