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

Metabolic Syndrome Clinical Trial

Official title: Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: A Randomized Controlled Pilot Trial

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This randomized pilot trial will test a group-based PP-MI intervention adapted for patients with MetS. MGH outpatient community clinics will serve as the sources of recruitment and the sites of the groups. The investigators will recruit up to 64 patients with MetS to complete the study and provide follow-up data.

Baseline information about enrolled participants will be obtained from the patients, care providers, and the electronic medical record as required for characterization of the population. This information will include medical data related to MetS (e.g., blood sugar, blood pressure, body mass index, triglycerides, cholesterol), current medications, and sociodemographic data (age, gender, race/ethnicity, education, marital status).

Participants will attend 90-minute groups sessions that will be held at the clinics (MGH Healthcare Centers). The overall structure of each session will be: 30 minutes for positive psychology exercise review/discussion, 30 minutes for physical activity goal setting, education, and discussion, and 30 minutes for a group walk or indoor exercises in inclement weather. 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). This study has been IRB-approved for waiver of informed consent documentation, so we will receive informed consent from our potential participants via verbal consent. We will mail/e-mail an IRB-approved study information fact sheet, providing them written details about our study before obtaining verbal informed consent. Each participant's verbal consent will be documented in REDCap. In addition, the group walks will not happen in these particular circumstances, and all exercise will be done individually to comply with social distancing measures.

Participants will be either randomized to an immediate intervention group or a wait-list control (WLC) group. The wait-list control group will start the intervention at Week 10, after the immediate intervention group completes its final session. Both groups will be asked to wear an Actigraph GT3x+ accelerometer for 1 week at baseline, then week 9, and week 24 for the intervention group, and at baseline, weeks 9, 17, and 33 for the WLC group. Accelerometers such as this one are considered to be the standard for measuring habitual physical activity. They are pedometer-size devices that attach to a belt and are worn at the waist. Participants will also be given a wrist-worn Fitbit to keep, which they will be asked to wear daily for the duration of the study in order to track their activity (steps).

Upon beginning the groups, participants will be provided with a treatment manual with weekly PP exercises, information about the importance of physical activity and related health behaviors, and how to set goals to improve these behaviors. The PI or a trained substitute will lead all groups.

For the first session, in the PP portion, participants will discuss and be assigned the first exercise- Gratitude for Positive Events- and will be instructed to complete the PP exercise during the next week. Prior to completing the exercise, participants will be asked to rate their current levels of happiness and optimism. Immediately after completing the exercise, participants will rate the ease of exercise completion, overall utility of the exercise, and their current levels of happiness and optimism, all using 10-point Likert scales. In the first goal-setting session, the investigators will discuss the importance of physical activity in MetS. Investigators will review instructions for Fitbit use and set a goal for monitoring their baseline physical activity over the next week. Fitbits will not be used as an outcome measure, but as a tool that participants can use to monitor their activity and set goals. Finally, the last 30 minutes will be spent doing a group walk around the local clinic neighborhood (or indoor exercise in the case of inclement weather). All group walks and exercises will be done at a pace comfortable for participants.

Participants will be asked to complete the 8 total weekly PP exercises, set physical activity goals, and attend as many group sessions as they can.

All sessions will include (a) a review and discussion of the past week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise using the PP manual, and (c) assignment of the next week's PP exercise. For the goal-setting/MI portion, participants will (a) review their goals and steps from the prior week, (b) discuss techniques for improving physical activity (e.g., monitoring physical activity, taking standing breaks), and (c) set goals for the next week. The exercises and content for both PP and MI will be assigned in the same order for all participants receiving them.

At Weeks 9 and 24 (Weeks 17 and 33 for the wait-list control group), participants will complete the same self-report questionnaires that were administered at baseline. The investigators will collect the Actigraphs at baseline, weeks 9 and 24 (baseline, Weeks 9, 17 and 33 for the WLC group) and upload the data to assess for valid wear time. If participants have not worn them for enough time (>4 days), the investigators will send it home with them and ask them to re-wear it and mail it back. ;

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

• NCT number: NCT04039165
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 25, 2019
• Completion date: January 4, 2023