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

Metabolic Syndrome Clinical Trial

— MAPP-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473886
• Other study ID #: 1K23HL135277-02
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 1, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• Intervention arm: PP-MI
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of PP-MI-Based Health Behavior Intervention Exercises Completed	Feasibility will be measured by examining the number of completed exercises.	8 weeks of group sessions
Primary	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	8 weeks of group sessions
Secondary	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.	8 weeks
Secondary	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.	Change in physical activity level from baseline to 8 weeks
Secondary	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.	Change in dispositional optimism from baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in # of fruits consumed/day from Baseline to 8 weeks
Secondary	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.	Change in number of times fat is consumed per day from Baseline to 8 weeks
Secondary	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).	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in score from Baseline to 8 weeks
Secondary	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.	Change in # of vegetables consumed/day from Baseline to 8 weeks