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The Pick Two to Stick To Habit Development Intervention

The Pick Two to Stick To Habit Development Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03370419
Acronym
P2S2
Enrollment
40
Registered
2017-12-12
Start date
2016-01-13
Completion date
2017-12-30
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome, Habits, African American, Emergency Medicine

Brief summary

Metabolic syndrome (MetS) is a leading risk factor for chronic disease among African American/Black populations. Fostering habit development offers a promising new approach to improving the effectiveness of lifestyle programs for people with MetS, yet this approach remains understudied. The long-term goal of this line of research is to test and disseminate an affordable and effective intervention for reducing MetS. The objective of the proposed project is to evaluate the feasibility of a novel, occupational therapist-delivered habit-development intervention targeting dietary and physical activity habits in up to 100 African American/Blacks with MetS ages 40+ recruited from an emergency department in Detroit, MI. The specific aims are to (a) evaluate intervention feasibility and acceptability and (b) estimate intervention effect sizes for primary outcome measures of habit development and weight loss and secondary outcomes of blood pressure, BMI, and waist circumference. Through the 8-week intervention, indicators of intervention feasibility (e.g., time, effort, costs, participant recruitment and retention, satisfaction) will be tracked. Measures of habit development will be taken biweekly over the 8-week active intervention period and anthropometry measures will be collected at baseline and week 20.

Detailed description

Together, diabetes and cardiovascular disease cost the U.S. economy a staggering $557.6 billion annually and are the leading chronic diseases of African Americans. Maintaining a healthy body weight by being physically active and eating a healthy diet are the best means of reducing cardio-metabolic risk factors. Despite decades of behavioral research, however, lifestyle interventions targeting activity and diet have made little progress in effecting widespread and enduring health behavior changes in the populations most at risk for developing these conditions. Addressing the role of habits, defined as behavior patterns operating below conscious awareness that are acquired through context-dependent repetition, would significantly improve the effectiveness of lifestyle interventions. Most simply, habits develop when repetition of a behavior (e.g., walking for 10 minutes) occurs in connection with a stable situational cue that supports the behavior (e.g., while on a lunch break). Once established, habits are cued by the characteristics of a specified recurring situation rather than by intentions. Recent research suggests that habit development may prevent relapse and aid maintenance of behavior changes beyond the duration of the intervention because the performance of habitual behaviors is less vulnerable to changes in motivation, mood, or extraneous circumstances. Emerging evidence also suggests that habit-development strategies are (a) effective across a range of behaviors (e.g., dental flossing, physical activity, and dietary behaviors); (b) effective in low doses; and (c) deliverable via multiple formats (e.g., paper or electronic). Such strategies could therefore be feasibly implemented in a range of settings to target the development of healthful physical activity and dietary habits. Nonetheless, these concepts and methods have yet to be fully tested to determine their feasibility as a treatment modality for promoting healthful lifestyle behavior changes. The long-term goal of the larger research project of which this is a part is to disseminate an affordable and effective intervention adaptable to a variety of healthcare settings for fostering healthful physical activity and dietary habits, thereby reducing the burden of related chronic diseases on affected individuals and society. The short-term objective of the proposed research is to test the feasibility of a habit-focused intervention in a sample of 80 African American adults ages 40 and older with metabolic syndrome (MetS). The overarching hypothesis is that a habit-focused approach will be feasible to implement and acceptable to intervention recipients. Rooted in habit theory and informed by the information-motivation-behavioral (IBM) model, the brief 8-week intervention consists of one face-to-face consultation, four bi-weekly individual tele-coaching sessions, and the use of ambulatory momentary assessments (via a smartphone application) to support the development of healthy dietary intake and physical activity habits and improve key health outcomes. The two specific aims of the study are: 1. To evaluate intervention feasibility and acceptability. Determine if the intervention used in the proposed project is feasible. By tracking time, effort, costs, adherence to recommendations, participant recruitment and retention rates, and intervention satisfaction, it is expected that we will obtain data that both support the feasibility of the intervention and help improve it for a subsequent study. 2. To estimate intervention effect sizes for the primary outcome measures of habit development and for the secondary outcome measures of blood pressure, BMI, and waist circumference. Habit development and anthropometry will be measured using the four-item Self-Reported Behavioral Automaticity Index (Gardner et al., 2012) biweekly during the active intervention, weeks 2, 4, 6, and 8.

Interventions

BEHAVIORALTreatment

Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors.

BEHAVIORALUsual care

Usual care

Sponsors

Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Two group randomized controll trial

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Two of the following three MetS risk factors (waistline \> 40 inches for men and \> 35 inches for women; blood pressure \> 130/85; HbA1c of 5.7%-6.4%) * Adults who present to the ED with non-life threatening conditions * English-speaking subjects who will be discharged to home from the ED

Exclusion criteria

* Pregnant patients * Previous diagnosis of resistant HTN * Steroid-dependent asthma or emphysema * Cirrhosis or hepatic failure * Cardiac event within the last 30 days * Chronic kidney disease on renal replacement therapy * Cancer (terminal or undergoing active chemotherapeutic or radiation therapy) * Taking medications for weight reduction or already being involved in a weight reduction program.

Design outcomes

Primary

MeasureTime frameDescription
Self-reported Behavioral Automaticity Index2 weeksHabit 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.

Participant flow

Participants by arm

ArmCount
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
40
Total40

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up16

Baseline characteristics

CharacteristicThe Pick Two to Stick To
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
40 Participants
Age, Continuous49 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
40 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
40 participants
Sex: Female, Male
Female
27 Participants
Sex: Female, Male
Male
13 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 40
other
Total, other adverse events
0 / 40
serious
Total, serious adverse events
0 / 40

Outcome results

Primary

Self-reported Behavioral Automaticity Index

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.

Time frame: 2 weeks

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

ArmMeasureValue (MEAN)Dispersion
The Pick Two to Stick ToSelf-reported Behavioral Automaticity Index10.4 score on a scaleStandard Error 0.4

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026