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The Pick Two to Stick To Habit Development Intervention (P2S2)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treatment
Usual care
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Habits, African American, Emergency Medicine

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    The Pick Two to Stick To

    Usual Care

    Arm Description

    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.

    Participants receive usual care only.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2017
    Last Updated
    January 2, 2020
    Sponsor
    Wayne State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03370419
    Brief Title
    The Pick Two to Stick To Habit Development Intervention
    Acronym
    P2S2
    Official Title
    The Pick Two to Stick To Habit Development Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 13, 2016 (Actual)
    Primary Completion Date
    August 30, 2017 (Actual)
    Study Completion Date
    December 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wayne State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    Metabolic syndrome, Habits, African American, Emergency Medicine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two group randomized controll trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The Pick Two to Stick To
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    Other
    Arm Description
    Participants receive usual care only.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment
    Intervention Description
    Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual care
    Intervention Description
    Usual care
    Primary Outcome Measure Information:
    Title
    Self-reported Behavioral Automaticity Index
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heather Fritz, PhD
    Organizational Affiliation
    Wayne State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30991972
    Citation
    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.
    Results Reference
    derived

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