Motivation-Audit-Positive Psychology Intervention Study

NCT03160755 | Completed

• 1 other identifier: 2016P002824
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim #1: To identify, through qualitative research, deficits in positive emotional states (e.g., positive affect, optimism) and associated barriers to completing health behaviors, like physical activity and healthy eating, in patients with metabolic syndrome (MetS). Hypothesis: Participants will be able to complete semi-structured interviews, providing information about their positive emotional states, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, motivational) to completing such behaviors.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Qualitative Data

  Themes related to: health behaviors, barriers to completing health behaviors, positive emotional/cognitive experiences and how these may impact adherence to the MetS health behaviors of interest (primarily physical activity).

  Baseline

Secondary Outcomes (8)

• Dispositional Optimism

  Baseline

• Positive Affect

  Baseline

• Anxiety

  Baseline

• Depression

  Baseline

• Environmental Barriers and Resources

  Baseline

Study Arms (1)

Qualitative Interviews

Adult outpatients with metabolic syndrome.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Metabolic syndrome patients with a Partners Healthcare provider

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachel Millstein, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychology

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: April 18, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)