Clinical trial NCT04039165: Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: RCT
Official title: Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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.

OR

* 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.

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.
* Participation in any other research studies or clinical trials that focus on increasing physical activities

Primary outcomes:
measure: Feasibility of the PP-MI-Based Health Behavior Intervention
timeFrame: 8 weeks of group sessions
Secondary outcomes:
measure: Acceptability of Intervention
timeFrame: 8 weeks
measure: Physical Activity Adherence (Actigraph)
timeFrame: Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group)
measure: Feasibility of Actigraph
timeFrame: Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group)
measure: Changes in Life Orientation Test- Revised Scores
timeFrame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
measure: Changes in Positive and Negative Affect Schedule Scores
timeFrame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
measure: Changes in The Hospital Anxiety and Depression Scale Scores
timeFrame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
measure: Changes in Barriers to Being Active Quiz Scores
timeFrame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
measure: Changes in State Optimism Measure
timeFrame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
measure: Changes in The Medical Outcomes Study Short Form-12 Scores
timeFrame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
measure: Changes in The International Physical Activity Questionnaire-Short Form Scores
timeFrame: Pre-baseline screening, weeks 9, 24 (Pre-baseline, weeks 17 and 33 for the WLC group)
measure: Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module
timeFrame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
measure: Changes in National Cancer Institute's Percentage Energy from Fat Screener Scores
timeFrame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
Other outcomes:
Locations:
city: Revere
country: United States
facility: Massachusetts General Hospital- Revere Health Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel A Millstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: