NCT03473886: MAPP-II

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

Completed NA Results posted Last updated 12 May 2020

What this trial tests

NA trial testing Intervention arm: PP-MI in Metabolic Syndrome in 8 participants. Completed in 1 June 2019.

Timeline

1 June 2018

Primary endpoint
15 April 2019

1 June 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 June 2018
Primary completion	15 April 2019
Estimated completion	1 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Intervention arm: PP-MI

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 100, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of PP-MI-Based Health Behavior Intervention Exercises Completed Primary · 8 weeks of group sessions

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

Group	Value	95% CI
Intervention Arm: PP-MI	7.0	± 0.5

Number of Participants Completing Objective Physical Activity Measurement Primary · 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

Group	Value	95% CI
Intervention Arm: PP-MI	7

Acceptability of Intervention Secondary · 8 weeks

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.

Group	Value	95% CI
Intervention Arm: PP-MI	8.1	± 1.0

Physical Activity Adherence (Actigraph) Secondary · Change in physical activity level from baseline to 8 weeks

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.

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	12.5	± 10.74

Week 8

Group	Value	95% CI
Intervention Arm: PP-MI	40.9	± 70.6

Changes in Life Orientation Test- Revised Scores Secondary · Change in dispositional optimism from baseline to 8 weeks

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.

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	11.7	± 2.8

8 Weeks

Group	Value	95% CI
Intervention Arm: PP-MI	10.1	± 3.1

Changes in Positive and Negative Affect Schedule Scores Secondary · Change in score from Baseline to 8 weeks

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.

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	36.1	± 5.0

8 Weeks

Group	Value	95% CI
Intervention Arm: PP-MI	40.7	± 5.3

Changes in The HADS-A Scores Secondary · Change in score from Baseline to 8 weeks

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.

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	6.7	± 2.0

8 Weeks

Group	Value	95% CI
Intervention Arm: PP-MI	5.6	± 2.8

Changes in The Neighborhood Environment Walkability Scale-Abbreviated Scores Secondary · Change in score from Baseline to 8 weeks

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.

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	10.7	± 1.6

8 Weeks

Group	Value	95% CI
Intervention Arm: PP-MI	10.8	± 1.8

Changes in Barriers to Being Active Quiz- Lack of Time Scores Secondary · Baseline and 8 weeks

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

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	2.0	± 2.5

8 Weeks

Group	Value	95% CI
Intervention Arm: PP-MI	2.3	± 2.0

Changes in The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score Secondary · Change in score from Baseline to 8 weeks

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.

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	41.9	± 6.0

8 Weeks

Group	Value	95% CI
Intervention Arm: PP-MI	44.6	± 9.9

Changes in The Community Healthy Activities Model Program for Seniors Scores Secondary · Change in score from Baseline to 8 weeks

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.

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	14.6	± 7.7

8 Weeks

Group	Value	95% CI
Intervention Arm: PP-MI	23.1	± 3.6

Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category Secondary · Change in # of fruits consumed/day from Baseline to 8 weeks

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.

Baseline

Group	Value	95% CI
Intervention Arm: PP-MI	1.2	± 1.5

8 Weeks

Group	Value	95% CI
Intervention Arm: PP-MI	1.1	± 0.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Arm: PP-MI

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention Arm: PP-MI
Pain after walking	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT03473886 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.