Motivation-Audit-Positive Psychology Intervention Study

Metabolic Syndrome Clinical Trial

— MAPP-I  

Official title:

Developing a Group-based Positive Psychology and Physical Activity Intervention in Patients With Metabolic Syndrome: Qualitative Research Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160755
• Other study ID #: 2016P002824
• Status: Completed
• Start date: April 18, 2017
• Est. completion date: November 20, 2017

Study information

• Verified date: August 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dispositional Optimism	Measured by the Life Orientation Test-Revised (LOT-R)	Baseline
Secondary	Positive Affect	Measured using the 10 positive affect items on the Positive and Negative Affect Schedule (PANAS)	Baseline
Secondary	Anxiety	Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)	Baseline
Secondary	Depression	Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)	Baseline
Secondary	Environmental Barriers and Resources	Measured using the Neighborhood Environment Walkability Scale - Abbreviated (NEWS-A)	Baseline
Secondary	Barriers to Physical Activity	Measured using the Barriers to Being Active Quiz	Baseline
Secondary	Health Related Quality of Life	Assessed via the Medical Outcomes Study Short Form-12 (SF-12)	Baseline
Secondary	Physical Activity	Assessed using the well-validated International Physical Activity Questionnaire-Short Form (IPAQ-SF)	Baseline