Trial Outcomes & Findings for The Pick Two to Stick To Habit Development Intervention (NCT NCT03370419)

Last Updated: 2020-01-14

Results Overview

Habit strength, operationalized as changes in behavioral automaticity, were measured using a 1-7-point Likert scale. Participants respond to 4 stem statements. The scale thus ranges from 4-28. Higher score indicated a stronger habit.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

2 weeks

Results posted on

2020-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	The Pick Two to Stick To Participants are asked to participate in five health-coaching sessions and to return in Week 20 for follow-up data collection. The initial face-to-face coaching session lasts approximately 90 minutes with subsequent telephone sessions lasting approximately 20 minutes. Coaching sessions will include education about MetS, weight loss, dietary and physical activity recommendations, and the principles of habit development, guidance in forming implementation intentions for each self-selected habit, and identifying routines and contextual cues that could be modified to support habit development Coaching sessions are augmented with a participant workbook. Participants' also receive individually tailored study text messages to maintain their motivation. The Pick Two to Stick To Habit Development Intervention: Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors. Control: usual care
Overall Study STARTED	40
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	The Pick Two to Stick To Participants are asked to participate in five health-coaching sessions and to return in Week 20 for follow-up data collection. The initial face-to-face coaching session lasts approximately 90 minutes with subsequent telephone sessions lasting approximately 20 minutes. Coaching sessions will include education about MetS, weight loss, dietary and physical activity recommendations, and the principles of habit development, guidance in forming implementation intentions for each self-selected habit, and identifying routines and contextual cues that could be modified to support habit development Coaching sessions are augmented with a participant workbook. Participants' also receive individually tailored study text messages to maintain their motivation. The Pick Two to Stick To Habit Development Intervention: Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors. Control: usual care
Overall Study Lost to Follow-up	16

Baseline Characteristics

The Pick Two to Stick To Habit Development Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Pick Two to Stick To n=40 Participants Participants are asked to participate in five health-coaching sessions and to return in Week 20 for follow-up data collection. The initial face-to-face coaching session lasts approximately 90 minutes with subsequent telephone sessions lasting approximately 20 minutes. Coaching sessions will include education about MetS, weight loss, dietary and physical activity recommendations, and the principles of habit development, guidance in forming implementation intentions for each self-selected habit, and identifying routines and contextual cues that could be modified to support habit development Coaching sessions are augmented with a participant workbook. Participants' also receive individually tailored study text messages to maintain their motivation. The Pick Two to Stick To Habit Development Intervention: Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors. Control: usual care
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	13 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	40 Participants n=5 Participants
Race (NIH/OMB) White	0 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	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: 12 of the 24 participants who entered the trial dropped and as such there was only complete data on 12 participants.

Outcome measures

Outcome measures
Measure	The Pick Two to Stick To n=12 Participants Participants are asked to participate in five health-coaching sessions and to return in Week 20 for follow-up data collection. The initial face-to-face coaching session lasts approximately 90 minutes with subsequent telephone sessions lasting approximately 20 minutes. Coaching sessions will include education about MetS, weight loss, dietary and physical activity recommendations, and the principles of habit development, guidance in forming implementation intentions for each self-selected habit, and identifying routines and contextual cues that could be modified to support habit development Coaching sessions are augmented with a participant workbook. Participants' also receive individually tailored study text messages to maintain their motivation. The Pick Two to Stick To Habit Development Intervention: Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors. Control: usual care
Self-reported Behavioral Automaticity Index	10.4 score on a scale Standard Error 0.4

Adverse Events

The Pick Two to Stick To

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

Heather Fritz

Wayen State University

Phone: 313-577-9499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place