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N/A Completed N=40 Randomized Prevention

The Pick Two to Stick To Habit Development Intervention

Source: ClinicalTrials.gov NCT03370419 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Self-reported Behavioral Automaticity Index — 10.4 score on a scale

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Self-reported Behavioral Automaticity Index
10.4

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03370419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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