Status:
COMPLETED
Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the positive psychology (PP)-motivational interviewing (MI) group-based physical activity intervention and outcome assessments ...
Detailed Description
In this proof-of-concept study, investigators will run two 8-week PP-MI groups (complete n=8 each, n=16 total) for primary care patients with MetS. Investigators will use ratings of feasibility and ac...
Eligibility Criteria
Inclusion
- • Both of the two MetS components most strongly related to MetS outcomes and most sensitive to lifestyle change:
- elevated abdominal obesity (waist circumference \>102 cm in men or \>88 cm in women)
- If waist circumference is not available, body mass index (BMI) will be used as a surrogate measure based on prior research (BMI ≥29.1 kg/m2 for men and 27.2 kg/m2 for women).
- AND
- \- elevated blood pressure (systolic ≥130 and/or diastolic ≥85 mm Hg or be on blood pressure medication).
- Plus ≥1 additional MetS component:
- Serum triglycerides ≥150 mg/dL
- High-density lipoprotein (HDL) cholesterol \<40 mg/dL in men or \<50 mg/dL in women
- Fasting plasma glucose \>100mg/dL.
- Suboptimal physical activity defined as ≤150 minutes/week moderate intensity activity, which represents less than national-level recommendations.
Exclusion
- Inability to speak/read English
- Cognitive deficits impeding ability to participate or provide informed consent (measured by a 6-item screen)
- Illness likely to lead to death in the next 6 months per PCP
- Current treatment for cancer, liver, or renal disease
- Pregnancy
- Documented severe mental illness (e.g., psychosis, suicidality)
- No telephone access
- Inability to be physically active
- Diabetes or known or suggested cardiac disease, given that this is a primary prevention study.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03473886
Start Date
June 1 2018
End Date
June 1 2019
Last Update
May 12 2020
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114