Clinical trial NCT03473886: Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
Official title: Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: In this proof-of-concept study, investigators will run two 8-week PP-MI groups (complete n=8 each, n=16 total) for primary care patients with MetS. Investigators will use ratings of feasibility and acceptability for each of the sessions and obtain objective physical activity measures pre- and post- group. Investigators will also obtain questionnaire-based information related to health behavior adherence and psychological and physical health to ensure the feasibility of these methods prior to further testing. Investigators may gather exit interview data to assess participant liking, utility, and additional needs, to allow for further refinement of the intervention.

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 two primary care 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.

Participants will be asked to wear an Actigraph GT3x+ accelerometer for 1 week at baseline and 1 week at follow-up to assess the feasibility of doing so. 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 Fitbit Zip 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 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, we will discuss the importance of physical activity in MetS. Participants will be given a Fitbit Zip to keep, which they will use to track the number of steps they take each day, for the duration of the study. Investigators will review instructions for 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. 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.

Immediately after the week 8 session, investigators will distribute the same self-report questionnaires that were administered at baseline (before week 1). The Actigraphs will then be collected at this point and the data will be uploaded to assess for valid wear time. If participants have not worn them for enough time (\>4 days), investigators will send it home with them and ask them to re-wear it and mail it back.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of PP-MI-Based Health Behavior Intervention Exercises Completed
timeFrame: 8 weeks of group sessions
measure: Number of Participants Completing Objective Physical Activity Measurement
timeFrame: 8 weeks of group sessions
Secondary outcomes:
measure: Acceptability of Intervention
timeFrame: 8 weeks
measure: Physical Activity Adherence (Actigraph)
timeFrame: Change in physical activity level from baseline to 8 weeks
measure: Changes in Life Orientation Test- Revised Scores
timeFrame: Change in dispositional optimism from baseline to 8 weeks
measure: Changes in Positive and Negative Affect Schedule Scores
timeFrame: Change in score from Baseline to 8 weeks
measure: Changes in The HADS-A Scores
timeFrame: Change in score from Baseline to 8 weeks
measure: Changes in The Neighborhood Environment Walkability Scale-Abbreviated Scores
timeFrame: Change in score from Baseline to 8 weeks
measure: Changes in Barriers to Being Active Quiz- Lack of Time Scores
timeFrame: Baseline and 8 weeks
measure: Changes in The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score
timeFrame: Change in score from Baseline to 8 weeks
measure: Changes in The Community Healthy Activities Model Program for Seniors Scores
timeFrame: Change in score from Baseline to 8 weeks
measure: Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category
timeFrame: Change in # of fruits consumed/day from Baseline to 8 weeks
measure: Changes in National Cancer Institute's Percentage Energy From Fat Screener Scores
timeFrame: Change in number of times fat is consumed per day from Baseline to 8 weeks
measure: Change in HADS-D Scores
timeFrame: Change in score from Baseline to 8 weeks
measure: Change in Barriers to Being Active Quiz Score- Social Influence
timeFrame: Change in score from Baseline to 8 weeks
measure: Change in Barriers to Being Active Quiz Score- Lack of Energy
timeFrame: Change in score from Baseline to 8 weeks
measure: Change in Barriers to Being Active Quiz Score- Lack of Willpower
timeFrame: Change in score from Baseline to 8 weeks
measure: Change in Barriers to Being Active Quiz Score - Fear of Injury
timeFrame: Change in score from Baseline to 8 weeks
measure: Change in Barriers to Being Active Quiz Score - Lack of Skill
timeFrame: Change in score from Baseline to 8 weeks
measure: Change in Barriers to Being Active Quiz Score - Lack of Resources
timeFrame: Change in score from Baseline to 8 weeks
measure: Change in SF-12 Scores - Mental Composite Score
timeFrame: Change in score from Baseline to 8 weeks
measure: Change in BRFSS- Vegetable Module
timeFrame: Change in # of vegetables consumed/day from Baseline to 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel Millstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: