Metabolic SyndromeMAPP-INCT03160755
Motivation-Audit-Positive Psychology Intervention Study
An observational study of Metabolic Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Specific Aim #1: To identify, through qualitative research, deficits in positive emotional states (e.g., positive affect, optimism) and associated barriers to completing health behaviors, like physical activity and healthy eating, 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
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2017to 20 Nov 2017
- Phase
- Observational
- 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
Study population: Metabolic syndrome patients with a Partners Healthcare provider
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:
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- 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)
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- 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
Official title: Developing a Group-based Positive Psychology and Physical Activity Intervention in Patients With Metabolic Syndrome: Qualitative Research Phase
Specific Aim #1: To identify, through qualitative research, deficits in positive emotional states (e.g., positive affect, optimism) and associated barriers to completing health behaviors, like physical activity and healthy eating, in patients with metabolic syndrome (MetS).
Hypothesis: Participants will be able to complete semi-structured interviews, providing information about their positive emotional states, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, motivational) to completing such behaviors.
Read the detailed description
This qualitative interview study will focus on the development of a novel positive psychology (PP) and motivational interviewing (MI) intervention that is adapted for patients with MetS. For this phase, participants will be primary care patients recruited through Massachusetts General Hospital's research opt-in program (Research Options Direct to You [RODY]). We will complete phone interviews with patients (n=20) with MetS within two weeks of enrollment in the study.
In this project, we hope to do the following:
- Identify, through qualitative research, deficits in positive emotional states in primary care patients with MetS.
- Examine potential links between positive emotional deficits and impaired health behaviors (low physical activity, unhealthy dietary patterns), as well as links between positive emotional states and successful health behaviors.
- Identify other barriers to health behavior completion, such as social support and neighborhood resources.
- Explore strategies to enhance positive emotional states in MetS patients and inquire about the utility of potential PP exercises in these patients.
- Ask participants for feedback about intervention delivery preferences (e.g., session length, time of day, duration of intervention).
- Develop a preliminary PP-MI based group intervention using the above information.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative Interviews | Adult outpatients with metabolic syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Data
Themes related to: health behaviors, barriers to completing health behaviors, positive emotional/cognitive experiences and how these may impact adherence to the MetS health behaviors of interest (primarily physical activity).
Measured: Baseline
Secondary outcomes (8)
Dispositional Optimism
Measured by the Life Orientation Test-Revised (LOT-R)
Measured: Baseline
Positive Affect
Measured using the 10 positive affect items on the Positive and Negative Affect Schedule (PANAS)
Measured: Baseline
Anxiety
Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline
Depression
Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline
Environmental Barriers and Resources
Measured using the Neighborhood Environment Walkability Scale - Abbreviated (NEWS-A)
Measured: Baseline
Barriers to Physical Activity
Measured using the Barriers to Being Active Quiz
Measured: Baseline
Health Related Quality of Life
Assessed via the Medical Outcomes Study Short Form-12 (SF-12)
Measured: Baseline
Physical Activity
Assessed using the well-validated International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start18 Apr 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 24 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
- NCT03160755
- Sponsor's protocol ID
- 2016P002824
- Acronym
- MAPP-I
- Status last verified
- Aug 2019
- First submitted
- 18 May 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Group-based Positive Psychology and Physical Activity Intervention in Patients With Metabolic Syndrome: Qualitative Research Phase
- ClinicalTrials.gov ID
- NCT03160755
- Acronym / sponsor ID
- MAPP-I / 2016P002824
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
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: To identify, through qualitative research, deficits in positive emotional states (e.g., positive affect, optimism) and associated barriers to completing health behaviors, like physical activity and healthy eating, in patients with metabolic syndrome (MetS).
Hypothesis: Participants will be able to complete semi-structured interviews, providing information about their positive emotional states, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, motivational) to completing such behaviors.
Detailed description
This qualitative interview study will focus on the development of a novel positive psychology (PP) and motivational interviewing (MI) intervention that is adapted for patients with MetS. For this phase, participants will be primary care patients recruited through Massachusetts General Hospital's research opt-in program (Research Options Direct to You [RODY]). We will complete phone interviews with patients (n=20) with MetS within two weeks of enrollment in the study.
In this project, we hope to do the following:
- Identify, through qualitative research, deficits in positive emotional states in primary care patients with MetS.
- Examine potential links between positive emotional deficits and impaired health behaviors (low physical activity, unhealthy dietary patterns), as well as links between positive emotional states and successful health behaviors.
- Identify other barriers to health behavior completion, such as social support and neighborhood resources.
- Explore strategies to enhance positive emotional states in MetS patients and inquire about the utility of potential PP exercises in these patients.
- Ask participants for feedback about intervention delivery preferences (e.g., session length, time of day, duration of intervention).
- Develop a preliminary PP-MI based group intervention using the above information.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative Interviews | – | –Adult outpatients with metabolic syndrome. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metabolic syndrome patients with a Partners Healthcare provider
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.
Primary outcome
Qualitative Data
Time frame: Baseline
Themes related to: health behaviors, barriers to completing health behaviors, positive emotional/cognitive experiences and how these may impact adherence to the MetS health behaviors of interest (primarily physical activity).
8 secondary outcomes
Dispositional Optimism
Time frame: Baseline
Positive Affect
Time frame: Baseline
Anxiety
Time frame: Baseline
Depression
Time frame: Baseline
Environmental Barriers and Resources
Time frame: Baseline
Barriers to Physical Activity
Time frame: Baseline
Health Related Quality of Life
Time frame: Baseline
Physical Activity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- 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?
An observational study of 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 13 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Qualitative Data (time frame: Baseline). 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 13 Aug 2019.