Status:
UNKNOWN
Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: RCT
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 PP-MI group-based physical activity intervention and outcome assessments in patients with MetS. Hypothesis: The PP exercis...
Detailed Description
This randomized pilot trial will test a group-based PP-MI intervention adapted for patients with MetS. MGH outpatient community clinics will serve as the sources of recruitment and the sites of the gr...
Eligibility Criteria
Inclusion
- Participants must have at least three of the five MetS criteria:
- 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).
- Elevated blood pressure (systolic ≥130 and/or diastolic ≥85 mm Hg or be on blood pressure medication).
- 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.
- OR
- Fewer than 3 MetS criteria but with PCP approval
- 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.
- Participation in any other research studies or clinical trials that focus on increasing physical activities
Key Trial Info
Start Date :
July 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 4 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04039165
Start Date
July 25 2019
End Date
January 4 2023
Last Update
September 19 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital- Revere Health Center
Revere, Massachusetts, United States, 02151