N/A
N=8
Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03473886 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of PP-MI-Based Health Behavior Intervention Exercises Completed — 7.0 Exercises completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention arm: PP-MI (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of PP-MI-Based Health Behavior Intervention Exercises Completed |
7.0 | — |
| PRIMARY Number of Participants Completing Objective Physical Activity Measurement |
7 | — |
| SECONDARY Acceptability of Intervention |
8.1 | — |
| SECONDARY Physical Activity Adherence (Actigraph) |
12.5; 40.9 | — |
| SECONDARY Changes in Life Orientation Test- Revised Scores |
11.7; 10.1 | — |
| SECONDARY Changes in Positive and Negative Affect Schedule Scores |
36.1; 40.7 | — |
| SECONDARY Changes in The HADS-A Scores |
6.7; 5.6 | — |
| SECONDARY Changes in The Neighborhood Environment Walkability Scale-Abbreviated Scores |
10.7; 10.8 | — |
| SECONDARY Changes in Barriers to Being Active Quiz- Lack of Time Scores |
2.0; 2.3 | — |
| SECONDARY Changes in The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score |
41.9; 44.6 | — |
| SECONDARY Changes in The Community Healthy Activities Model Program for Seniors Scores |
14.6; 23.1 | — |
| SECONDARY Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category |
1.2; 1.1 | — |
| SECONDARY Changes in National Cancer Institute's Percentage Energy From Fat Screener Scores |
3.9; 3.4 | — |
| SECONDARY Change in HADS-D Scores |
4.6; 2.4 | — |
| SECONDARY Change in Barriers to Being Active Quiz Score- Social Influence |
3.4; 2.3 | — |
| SECONDARY Change in Barriers to Being Active Quiz Score- Lack of Energy |
1.3; 1.9 | — |
| SECONDARY Change in Barriers to Being Active Quiz Score- Lack of Willpower |
5.9; 2.1 | — |
| SECONDARY Change in Barriers to Being Active Quiz Score - Fear of Injury |
1.4; 1.1 | — |
| SECONDARY Change in Barriers to Being Active Quiz Score - Lack of Skill |
2.7; 1.1 | — |
| SECONDARY Change in Barriers to Being Active Quiz Score - Lack of Resources |
2.7; 1.4 | — |
| SECONDARY Change in SF-12 Scores - Mental Composite Score |
48.2; 54.2 | — |
| SECONDARY Change in BRFSS- Vegetable Module |
1.5; 1.9 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03473886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.