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

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ClinicalTrials.gov Identifier: NCT04039165
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Rachel Millstein, Massachusetts General Hospital

Brief 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 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.

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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: PP-MI Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: A Randomized Controlled Pilot Trial
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
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. 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.
Behavioral: PP-MI Intervention
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.

No Intervention: Wait-list Control Comparison Group
Participants 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.



Primary Outcome Measures :
  1. Feasibility of the PP-MI-Based Health Behavior Intervention [ Time Frame: 8 weeks of group sessions ]
    Feasibility will be measured by examining the number of completed exercises.


Secondary Outcome Measures :
  1. Acceptability of Intervention [ Time Frame: 8 weeks ]
    Participants will rate the ease and usefulness of each weekly activity (0-10).

  2. Physical Activity Adherence (Actigraph) [ Time Frame: Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group) ]
    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.

  3. Feasibility of Actigraph [ Time Frame: Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group) ]
    Feasibility will be measured by examining the rates of use of the Actigraph.

  4. Changes in Life Orientation Test- Revised Scores [ Time Frame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group) ]
    The LOT-R is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 5-30)

  5. Changes in Positive and Negative Affect Schedule Scores [ Time Frame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group) ]
    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)

  6. Changes in The Hospital Anxiety and Depression Scale Scores [ Time Frame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group) ]
    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)

  7. Changes in Barriers to Being Active Quiz Scores [ Time Frame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group) ]
    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)

  8. Changes in State Optimism Measure [ Time Frame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group) ]
    The SOM will be used to capture the changeable nature of optimism based on time and situation. (Range: 7-35)

  9. Changes in The Medical Outcomes Study Short Form-12 Scores [ Time Frame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group) ]
    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)

  10. Changes in The International Physical Activity Questionnaire-Short Form Scores [ Time Frame: Pre-baseline screening, weeks 9, 24 (Pre-baseline, weeks 17 and 33 for the WLC group) ]
    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.

  11. Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module [ Time Frame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group) ]
    The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables.

  12. Changes in National Cancer Institute's Percentage Energy from Fat Screener Scores [ Time Frame: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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
  • 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.

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.
  • Participation in any other research studies or clinical trials that focus on increasing physical activities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039165


Contacts
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Contact: Rachel A Millstein, Ph.D. 617-724-2047 ramillstein@partners.org
Contact: Jeff C Huffman, MD 617-724-2910 jhuffman@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital- Revere Health Center Recruiting
Revere, Massachusetts, United States, 02151
Contact: Rachel A Millstein, Ph.D.    617-724-2047    RAMILLSTEIN@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Rachel A Millstein, Ph.D. Massachusetts General Hospital
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Responsible Party: Rachel Millstein, Assistant Professor, Department of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04039165    
Other Study ID Numbers: 2019P001300
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases