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



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 100
Updated:8/18/2018
Start Date:June 1, 2018
End Date:October 27, 2018
Contact:Rachel Millstein, PhD
Email:ramillstein@partners.org
Phone:617-724-2047

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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.

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.

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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-2047
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mi
from
Boston, MA
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