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PP-MI Intervention for Metabolic Syndrome

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the wlc group) for reporting.

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 more

Awards & 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.

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