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Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: RCT
N/A
Waitlist Available
Led By Rachel A Millstein, Ph.D.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the wlc group)
Awards & highlights
No Placebo-Only Group
Summary
This trial assesses the feasibility, acceptability, and preliminary outcomes of a physical activity intervention for people with MetS. The intervention consists of group-based exercise sessions and goal-setting sessions using motivational interviewing techniques. The primary aim is to assess feasibility, and the secondary aim is to assess acceptability and preliminary outcomes.
Eligible Conditions
- Metabolic Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the wlc group)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the wlc group)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of the PP-MI-Based Health Behavior Intervention
Secondary study objectives
Acceptability of Intervention
Changes in Barriers to Being Active Quiz Scores
Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
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, and 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. During times when in-person visits cannot happen (e.g., COVID-19), we will do virtual group sessions instead of meeting at the clinics, conducted via videoconference platform (i.e., Zoom), the group walks will not happen, and all exercise will be done individually to comply with social distancing measures.
Group II: Wait-list Control Comparison GroupActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,025 Previous Clinical Trials
13,413,804 Total Patients Enrolled
14 Trials studying Metabolic Syndrome
917 Patients Enrolled for Metabolic Syndrome
Rachel A Millstein, Ph.D.Principal InvestigatorMassachusetts General Hospital