Boosting Emotions & Happiness in Outpatients Living With Diabetes: Phase I

Completed · Not applicable

Conditions studied: Type 2 Diabetes, Emotions, Patient Compliance

In brief

The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention in a group of patients with type 2 diabetes (T2D).

Key facts

Study ID

NCT03001999

Run by

Massachusetts General Hospital

People needed

12

Starts

2017-01-01

Expected to finish

2017-11-01

Last updated by the study team

2018-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• T2D. Eligible patients will be diagnosed with T2D, with diagnosis for at least 1 year, confirmed by their diabetes clinician or medical record review. Consistent with American Diabetes Association (ADA) criteria for T2D, participants must have HbA1c [A1C] of at least 6.5% within the last 6 months. The investigators will exclude patients with A1C>9% given that patients in this range will likely have more extreme nonadherence and/or require ongoing treatment adjustment, increasing the heterogeneity of this sample for this pilot project. If patients appear otherwise eligible, but do not have an A1C value within 6 months, they will be required to have a baseline A1C value of 6.5-9%.
• Low physical activity. The investigators will define low physical activity as ≤75 minutes/week of MVPA (representing ≤40% of ADA recommendations for moderate or greater intensity aerobic physical activity totaling 150 minutes per week). This cutoff allows adequate room for improvement on this key outcome. As an initial screen, the investigators will use a modified version of the International Physical Activity Questionnaire (IPAQ) which has been extensively used/validated in medical cohorts, including T2D. Patients will complete the modified IPAQ regarding their activity in the past week (or a typical week, if the past 7 days atypical) to assess number of minutes spent performing MVPA. Patients reporting ≤60 minutes/week of MVPA will then wear accelerometers for 7 days to confirm low physical activity.
• Prescribed an oral glucose-lowering drug or choosing lifestyle interventions (diet and exercise) to manage T2D. To be eligible, patients must be prescribed a stable glucose-lowering medication regimen (or stable plan for control with diet/exercise alone) for at least 3 months with no anticipated adjustment. Including those whose T2D is managed by diet and exercise alone will allow inclusion of participants who may have high likelihood of engagement in a behavioral intervention. The investigators will exclude patients taking insulin to reduce heterogeneity of T2D severity in this initial trial.

You may not qualify if…

• Cognitive impairment precluding consent or meaningful participation, assessed using a six-item screen developed for this purpose.
• Lack of phone availability.
• Inability to read/write in English.
• Additional medical conditions (e.g., severe arthritis, chronic pulmonary obstructive disease, class III or IV heart failure) that preclude physical activity.
• Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac rehabilitation), or other clinical trials.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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