Clinical trial NCT03160755: Motivation-Audit-Positive Psychology Intervention Study
Official title: Developing a Group-based Positive Psychology and Physical Activity Intervention in Patients With Metabolic Syndrome: Qualitative Research Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metabolic syndrome patients with a Partners Healthcare provider

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.

Detailed description: This qualitative interview study will focus on the development of a novel positive psychology (PP) and motivational interviewing (MI) intervention that is adapted for patients with MetS. For this phase, participants will be primary care patients recruited through Massachusetts General Hospital's research opt-in program (Research Options Direct to You \[RODY\]). We will complete phone interviews with patients (n=20) with MetS within two weeks of enrollment in the study.

In this project, we hope to do the following:

1. Identify, through qualitative research, deficits in positive emotional states in primary care patients with MetS.
2. Examine potential links between positive emotional deficits and impaired health behaviors (low physical activity, unhealthy dietary patterns), as well as links between positive emotional states and successful health behaviors.
3. Identify other barriers to health behavior completion, such as social support and neighborhood resources.
4. Explore strategies to enhance positive emotional states in MetS patients and inquire about the utility of potential PP exercises in these patients.
5. Ask participants for feedback about intervention delivery preferences (e.g., session length, time of day, duration of intervention).
6. Develop a preliminary PP-MI based group intervention using the above information.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Qualitative Data
timeFrame: Baseline
Secondary outcomes:
measure: Dispositional Optimism
timeFrame: Baseline
measure: Positive Affect
timeFrame: Baseline
measure: Anxiety
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Environmental Barriers and Resources
timeFrame: Baseline
measure: Barriers to Physical Activity
timeFrame: Baseline
measure: Health Related Quality of Life
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel Millstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: