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CompletedNCT03370419P2S2Updated Jan 14, 2020Results posted

The Pick Two to Stick To Habit Development Intervention

An interventional study of Treatment and Usual care in Metabolic Syndrome, sponsored by Wayne State University. Completed. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Wayne State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Metabolic Syndrome

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Keywords

  • Metabolic syndrome
  • Habits
  • African American
  • Emergency Medicine
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Treatment

  • Other
    Usual Care

    Participants receive usual care only.

    Behavioral: Usual care

Interventions

  • BehavioralTreatment

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

  • BehavioralUsual care

    Usual care

05

What researchers measure

Primary outcomes

  1. 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

06

Results

Posted Dec 2, 2019

Participant flow

Participant flow — Overall Study
MilestoneThe Pick Two to Stick To
Started40
Completed24
Not completed16
Withdrew: Lost to follow-up16

Outcome measures

PrimarySelf-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
Reported as:
Mean · score on a scale
Self-reported Behavioral Automaticity Index
score on a scaleThe Pick Two to Stick To
Self-reported Behavioral Automaticity Index10.4 ± 0.4

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
The Pick Two to Stick To0/40 (0%)0/40 (0%)0/40 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)The Pick Two to Stick To
<=18 years0
Between 18 and 65 years40
>=65 years0
Age, Continuous
Age, Continuous(years)The Pick Two to Stick To
Mean49 (40 to 63)
Sex: Female, Male
Sex: Female, Male(Participants)The Pick Two to Stick To
Female27
Male13
Race (NIH/OMB)
Race (NIH/OMB)(Participants)The Pick Two to Stick To
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American40
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)The Pick Two to Stick To
United States40
07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Fritz H, Tarraf W, Brody A, Levy P. Feasibility of a behavioral automaticity intervention among African Americans at risk for metabolic syndrome. BMC Public Health. 2019 Apr 16;19(1):413. doi: 10.1186/s12889-019-6675-7. PubMed 30991972 ↗

Study documents

  • Informed consent form · Jan 4, 2016
  • Protocol and statistical analysis plan · Jul 3, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03370419
Lead sponsor
Wayne State University
Responsible party
Heather Fritz (Assistant Professor of Occupational Therapy and Gerontology, Wayne State University) — Principal investigator
First posted
Dec 12, 2017
Start date
Jan 13, 2016
Primary completion
Aug 30, 2017
Completion
Dec 30, 2017
Results posted
Dec 2, 2019
Last update
Jan 14, 2020

Study contacts

Heather Fritz, PhD
principal investigator · Wayne State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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