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Metabolic SyndromeNCT04039165

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

A study testing PP-MI Intervention in people with Metabolic Syndrome, run by Massachusetts General Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
PP-MI Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
25 Jul 2019to 4 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital- Revere Health Center

    Revere, Massachusetts, 02151

Other trials in United States

About this study

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

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.

Read more

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.

Read the 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.

Being tested
PP-MI Intervention
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PP-MI InterventionBehavioural

    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.

Study groups in NCT04039165
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: PP-MI Intervention
Wait-list Control Comparison GroupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the PP-MI-Based Health Behavior Intervention

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

    Measured: 8 weeks of group sessions

Secondary outcomes (12)
  1. Acceptability of Intervention

    Participants will rate the ease and usefulness of each weekly activity (0-10).

    Measured: 8 weeks

  2. Physical Activity Adherence (Actigraph)

    ActiGraph GT3X+ accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer to assess the feasibility of doing so and to ensure adequate capture of physical activity.

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

  3. Feasibility of Actigraph

    Feasibility will be measured by examining the rates of use of the Actigraph.

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

  4. Changes in Life Orientation Test- Revised Scores

    The LOT-R is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 5-30)

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

  5. Changes in Positive and Negative Affect Schedule Scores

    The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials, will be used to measure positive affect. (Range: 10-50)

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

  6. Changes in The Hospital Anxiety and Depression Scale Scores

    The HADS will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: HADS-A, HADS-D; 0-21 each)

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

  7. Changes in Barriers to Being Active Quiz Scores

    The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), that explores seven main categories of barriers, including lack of time, energy, and resources. (Range: 0-63)

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

  8. Changes in State Optimism Measure

    The SOM will be used to capture the changeable nature of optimism based on time and situation. (Range: 7-35)

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

  9. Changes in The Medical Outcomes Study Short Form-12 Scores

    The SF-12 will be used to measure quality of life. This instrument has been used in many patient-oriented studies. (Range: SF-12 PCS and SF-12 MCS); range 0-100 each)

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

  10. Changes in The International Physical Activity Questionnaire-Short Form Scores

    The IPAQ-SF is a validated scale that measures self-reported physical activity in the past 7 days in the domains of vigorous activity, moderate activity, and walking.

    Measured: Pre-baseline screening, weeks 9, 24 (Pre-baseline, weeks 17 and 33 for the WLC group)

  11. Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module

    The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables.

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

  12. Changes in National Cancer Institute's Percentage Energy from Fat Screener Scores

    The National Cancer Institute's Percentage Energy from Fat Screen is a brief questionnaire that estimates people's typical percentage of energy derived from eating common fat-containing foods, as fat content is related to metabolic syndrome progression.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2019
  2. Study start25 Jul 2019
  3. Primary completion17 Aug 2022
  4. Study completion4 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04039165
Sponsor's protocol ID
2019P001300
Status last verified
Sep 2022
First submitted
29 Jul 2019
Last updated
19 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PP-MI Intervention in people with Metabolic Syndrome, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the PP-MI-Based Health Behavior Intervention (time frame: 8 weeks of group sessions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.

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