Metabolic SyndromeMAPP-IINCT03473886
Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
A study testing Intervention arm: PP-MI in people with Metabolic Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). 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?
- Intervention arm: PP-MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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:
Show all 10Show fewer
- 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.
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 9Show fewer
- No telephone access
- Inability to be physically active
- Diabetes or known or suggested cardiac disease, given that this is a primary prevention study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Intervention arm: PP-MI
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm: PP-MIBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention Arm: PP-MI | Experimental | Participants 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, as complete a group walk or indoor exercise during the group sessions. We 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. Receives: Behavioral: Intervention arm: PP-MI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PP-MI-Based Health Behavior Intervention Exercises Completed
Feasibility will be measured by examining the number of completed exercises.
Measured: 8 weeks of group sessions
Number of Participants Completing Objective Physical Activity Measurement
Feasibility will be measured by examining the number of participants who wore Actigraphs with sufficient wear time both at baseline and at follow-up
Measured: 8 weeks of group sessions
Secondary outcomes (20)
Acceptability of Intervention
Acceptability of the intervention was assessed through participants' ratings of each PP and MI exercise. Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful;10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.
Measured: 8 weeks
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: Change in physical activity level from baseline to 8 weeks
Changes in Life Orientation Test- Revised Scores
Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher levels of optimism.
Measured: Change in dispositional optimism from baseline to 8 weeks
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 and in patients with HF, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher levels of positive affect.
Measured: Change in score from Baseline to 8 weeks
Changes in The HADS-A Scores
The Hospital Anxiety and Depression Scale 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:0-21) Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher levels of anxiety.
Measured: Change in score from Baseline to 8 weeks
Changes in The Neighborhood Environment Walkability Scale-Abbreviated Scores
Measure Description: NEWS is a 98-question instrument that assesses the perception of neighborhood design features related to physical activity. NEWS-A is an abbreviated version and will be used to measure residents' perceptions of neighborhood design related to physical activity, including places for walking and cycling, aesthetics, traffic hazards, and crime (Range: 16-64). Higher scores indicate greater perceived walkability.
Measured: Change in score from Baseline to 8 weeks
Changes in Barriers to Being Active Quiz- Lack of Time Scores
The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of time" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.
Measured: Baseline and 8 weeks
Changes in The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score
The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher level of health related QoL.
Measured: Change in score from Baseline to 8 weeks
Changes in The Community Healthy Activities Model Program for Seniors Scores
CHAMP is a self-report questionnaire that assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. It includes activities of various intensities (from light to vigorous) such as walking, running, hiking, swimming, bicycling, dancing, tennis, aerobics, yoga/tai chi, gardening, and housework. The activities are assessed in min/week.
Measured: Change in score from Baseline to 8 weeks
Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category
Measure Description: The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables. It assesses the frequency of consumption of 100% fruit juice, fruit, beans (legumes), dark green vegetables, orange vegetables, and other vegetables over the past month. The outcome measure is the number of fruits consumed per day.
Measured: Change in # of fruits consumed/day from Baseline to 8 weeks
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. The questionnaire converts an individual's responses to an estimate of that individual's percentage energy from fat. Higher scores indicate higher fat consumption.
Measured: Change in number of times fat is consumed per day from Baseline to 8 weeks
Change in HADS-D Scores
The Hospital Anxiety and Depression Scale 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: 0-21). Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).
Measured: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score- Social Influence
The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "social influence" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.
Measured: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score- Lack of Energy
The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of energy" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.
Measured: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score- Lack of Willpower
The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of will power" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.
Measured: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score - Fear of Injury
The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "fear of injury" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.
Measured: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score - Lack of Skill
The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of skill" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.
Measured: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score - Lack of Resources
The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of resources" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.
Measured: Change in score from Baseline to 8 weeks
Change in SF-12 Scores - Mental Composite Score
The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher level of health related QoL.
Measured: Change in score from Baseline to 8 weeks
Change in BRFSS- Vegetable Module
Measure Description: The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables. It assesses the frequency of consumption of 100% fruit juice, fruit, beans (legumes), dark green vegetables, orange vegetables, and other vegetables over the past month. The outcome measure is the number of vegetables consumed per day.
Measured: Change in # of vegetables consumed/day from Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Jun 2018
- Primary completion15 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Millstein, Massachusetts General Hospital
- Investigators
- Rachel Millstein, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473886
- Sponsor's protocol ID
- 1K23HL135277-02
- Acronym
- MAPP-II
- Status last verified
- Apr 2020
- First submitted
- 8 Mar 2018
- Last updated
- 12 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
- ClinicalTrials.gov ID
- NCT03473886
- Acronym / sponsor ID
- MAPP-II / 1K23HL135277-02
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: PP-MI | Experimental | Behavioral: Intervention arm: PP-MIParticipants 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, as complete a group walk or indoor exercise during the group sessions. We 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention arm: PP-MIThe 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. | Behavioural | Intervention Arm: PP-MI |
Primary outcome
Number of PP-MI-Based Health Behavior Intervention Exercises Completed
Time frame: 8 weeks of group sessions
Feasibility will be measured by examining the number of completed exercises.
Number of Participants Completing Objective Physical Activity Measurement
Time frame: 8 weeks of group sessions
Feasibility will be measured by examining the number of participants who wore Actigraphs with sufficient wear time both at baseline and at follow-up
20 secondary outcomes
Acceptability of Intervention
Time frame: 8 weeks
Physical Activity Adherence (Actigraph)
Time frame: Change in physical activity level from baseline to 8 weeks
Changes in Life Orientation Test- Revised Scores
Time frame: Change in dispositional optimism from baseline to 8 weeks
Changes in Positive and Negative Affect Schedule Scores
Time frame: Change in score from Baseline to 8 weeks
Changes in The HADS-A Scores
Time frame: Change in score from Baseline to 8 weeks
Changes in The Neighborhood Environment Walkability Scale-Abbreviated Scores
Time frame: Change in score from Baseline to 8 weeks
Changes in Barriers to Being Active Quiz- Lack of Time Scores
Time frame: Baseline and 8 weeks
Changes in The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score
Time frame: Change in score from Baseline to 8 weeks
Changes in The Community Healthy Activities Model Program for Seniors Scores
Time frame: Change in score from Baseline to 8 weeks
Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category
Time frame: Change in # of fruits consumed/day from Baseline to 8 weeks
Changes in National Cancer Institute's Percentage Energy From Fat Screener Scores
Time frame: Change in number of times fat is consumed per day from Baseline to 8 weeks
Change in HADS-D Scores
Time frame: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score- Social Influence
Time frame: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score- Lack of Energy
Time frame: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score- Lack of Willpower
Time frame: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score - Fear of Injury
Time frame: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score - Lack of Skill
Time frame: Change in score from Baseline to 8 weeks
Change in Barriers to Being Active Quiz Score - Lack of Resources
Time frame: Change in score from Baseline to 8 weeks
Change in SF-12 Scores - Mental Composite Score
Time frame: Change in score from Baseline to 8 weeks
Change in BRFSS- Vegetable Module
Time frame: Change in # of vegetables consumed/day from Baseline to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Millstein, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm: PP-MI 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 9 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: finished, as of the sponsor's last update on 12 May 2020. 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?
Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of PP-MI-Based Health Behavior Intervention Exercises Completed (time frame: 8 weeks of group sessions). The study lists 2 primary outcomes in all. 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 12 May 2020.