The Pick Two to Stick To Habit Development Intervention

NCT ID: NCT03370419

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-13
• Study Completion Date: 2017-12-30

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Treatment

Intervention Type: BEHAVIORAL

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

Usual Care

Participants receive usual care only.

Group Type: OTHER

Usual care

Intervention Type: BEHAVIORAL

Usual care

Interventions

Treatment

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

Intervention Type: BEHAVIORAL

Usual care

Usual care

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Heather Fritz

Assistant Professor of Occupational Therapy and Gerontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Fritz, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

References

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.

Reference Type: DERIVED

PMID: 30991972 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1601014563

Identifier Type: -

Identifier Source: org_study_id