The Pick Two to Stick To Habit Development Intervention

NCT03370419 | Completed Results

• 1 other identifier: 1601014563
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome; Habits; African American; Emergency Medicine

Outcome Measures

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.

  2 weeks

Study Arms (2)

The Pick Two to Stick To

EXPERIMENTAL

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

Usual Care

OTHER

Participants receive usual care only.

Behavioral: Usual care

Interventions

Treatment BEHAVIORAL

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

The Pick Two to Stick To

Usual care BEHAVIORAL

Usual care

Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead

Related Publications (1)

• 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.

  PMID: 30991972 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Habits

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Results Point of Contact

• Title: Heather Fritz
• Organization: Wayen State University

heather.fritz@wayne.edu

313-577-9499

Study Officials

• Heather Fritz, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupational Therapy and Gerontology

Model Details: Two group randomized controll trial

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 12, 2017
• Study Start: January 13, 2016
• Primary Completion: August 30, 2017
• Study Completion: December 30, 2017
• Last Updated: January 14, 2020
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share