Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: RCT

NCT04039165 | Unknown

• 1 other identifier: 2019P001300
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the PP-MI group-based physical activity intervention and outcome assessments in patients with MetS. Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of participants will complete 6/9 exercises/sessions. Furthermore, the investigators will be able to obtain objective physical activity measurement follow-up data from at least 80% of enrolled participants at the end of the intervention and 24 weeks later. Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to participants, as measured by ratings provided after each PP-MI session. Hypothesis: The intervention will be acceptable: participants will rate the PP-MI exercises with a mean score of at least 7 out of 10 on 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), psychological well-being (optimism, positive affect, anxiety, depression), and the exploratory outcomes of MetS-relevant physiological markers (e.g., blood pressure, weight, chart-reviewed lipids and HbA1C). Hypothesis a: The intervention will lead to improvements in physical activity, related health behaviors, optimism and positive affect, reductions in depression and anxiety at 9 weeks and 24 weeks compared to baseline (or the start of the intervention, for the WLC group). Hypothesis b: The hypothesis is that there will be improvements in the exploratory outcomes of the physiological markers, even if they do not reach significance.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Feasibility of the PP-MI-Based Health Behavior Intervention

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

  8 weeks of group sessions

Secondary Outcomes (12)

• Acceptability of Intervention

  8 weeks

• Physical Activity Adherence (Actigraph)

  Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group)

• Feasibility of Actigraph

  Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group)

• Changes in Life Orientation Test- Revised Scores

  Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

• Changes in Positive and Negative Affect Schedule Scores

  Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

Study Arms (2)

Intervention Group

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, and complete a group walk or indoor exercise during the group sessions. The investigators 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. During times when in-person visits cannot happen (e.g., COVID-19), we will do virtual group sessions instead of meeting at the clinics, conducted via videoconference platform (i.e., Zoom), the group walks will not happen, and all exercise will be done individually to comply with social distancing measures.

Behavioral: PP-MI Intervention

Wait-list Control Comparison Group

NO INTERVENTION

Participants in the waitlist control group will not receive any active intervention during the initial study period (weeks 1-9). At Week 10, this group will receive the same intervention and assessments as described in the active treatment group above.

Interventions

PP-MI Intervention 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 Group

Eligibility Criteria

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

You may qualify if:

• Participants must have at least three of the five MetS criteria:
• 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).
• Elevated blood pressure (systolic ≥130 and/or diastolic ≥85 mm Hg or be on blood pressure medication).
• 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.
• Fewer than 3 MetS criteria but with PCP approval
• 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.
• Participation in any other research studies or clinical trials that focus on increasing physical activities

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital- Revere Health Center

Revere, Massachusetts, 02151, 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 A Millstein, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry

Model Details: A group of participants, who will be randomized to wait-list control group, is assigned to a waiting list and receives intervention after the active treatment group.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: July 25, 2019
• Primary Completion: August 17, 2022
• Study Completion: January 4, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)