Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial

Completed · Not applicable

Conditions studied: Metabolic Syndrome

In brief

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 in patients with metabolic syndrome (MetS). Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of participants will complete 6/8 exercises/sessions. Furthermore, we will be able to obtain objective physical activity measurement follow-up data from at least 80% of enrolled participants at 8 weeks. Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to participants, as measured by ratings provided after each PP and MI exercise. Hypothesis: The intervention will be acceptable: participants will rate each PP and MI exercise with a mean score of at least 7 out of 10 on ratings of ease of completion and helpfulness. Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result in improvement of physical activity, related health behaviors (sedentary time, diet quality), and psychological well-being (optimism, positive affect, anxiety, depression). Hypothesis: The intervention will lead to improvements in physical activity, related health behaviors, optimism and positive affect, and reductions in depression and anxiety at 8 weeks compared to baseline.

Key facts

Study ID

NCT03473886

Run by

Massachusetts General Hospital

People needed

8

Starts

2018-06-01

Expected to finish

2019-06-01

Last updated by the study team

2020-05-12

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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