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

NCT03473886 | Completed Results DMC

• 1 other identifier: 1K23HL135277-02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Number of PP-MI-Based Health Behavior Intervention Exercises Completed

  Feasibility will be measured by examining the number of completed exercises.

  8 weeks of group sessions

• Number of Participants Completing Objective Physical Activity Measurement

  Feasibility will be measured by examining the number of participants who wore Actigraphs with sufficient wear time both at baseline and at follow-up

  8 weeks of group sessions

Secondary Outcomes (20)

• Acceptability of Intervention

  8 weeks

• Physical Activity Adherence (Actigraph)

  Change in physical activity level from baseline to 8 weeks

• Changes in Life Orientation Test- Revised Scores

  Change in dispositional optimism from baseline to 8 weeks

• Changes in Positive and Negative Affect Schedule Scores

  Change in score from Baseline to 8 weeks

• Changes in The HADS-A Scores

  Change in score from Baseline to 8 weeks

Study Arms (1)

Intervention Arm: PP-MI

EXPERIMENTAL

Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program.

Behavioral: Intervention arm: PP-MI

Interventions

Intervention arm: PP-MI BEHAVIORAL

The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walkability.

Intervention Arm: PP-MI

Eligibility Criteria

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

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

Results Point of Contact

• Title: Rachel A. Millstein
• Organization: Massachusetts General Hospital

RAMILLSTEIN@mgh.harvard.edu

617-724-2047

Study Officials

• Rachel Millstein, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychology

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 22, 2018
• Study Start: June 1, 2018
• Primary Completion: April 15, 2019
• Study Completion: June 1, 2019
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)