Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05420051
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Positive Psychology + Motivational Interviewing — BEHAVIORAL
    The 8-week PP-MI intervention focuses on enhancing well-being (through PP) and increasing physical activity (through MI). Each week, participants will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to improve physical activity levels, resolve ambivalence to behavior change, set realistic physical activity goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 16 weeks) to encourage completion of PP activities and engagement in physical activity.
  • Motivational Interviewing — BEHAVIORAL
    The 8-week MI-alone intervention focuses on providing education and enhancing motivation to engage in health behaviors (through MI). Each week, participants will complete an activity related to a health behavior (e.g., consider the pros and cons of behavior change, set a health behavior goal), then complete a phone session with a study trainer. This program will focus on assisting participants to improve health behavior adherence (including physical activity), resolve ambivalence to behavior change, set realistic health behavior goals, problem-solve barriers, and identify resources to complete behavior change. Additional time in MI-alone phone sessions will be spent on review of core MI skills, problem-solving of barriers, and discussion of resources. Finally, participants will receive twice weekly text messages (for 16 weeks) to encourage engagement in health behaviors.

Study Details

The focus of this study is to test the efficacy of an 8-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks), compared to MI-alone, in a randomized trial of 280 individuals with type 2 diabetes and low baseline physical activity.

Key Dates

Start date
Oct 12, 2022
Status verified
Apr 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Positive Psychology + Motivational Interviewing
    Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).
  • Active Comparator: Motivational Interviewing
    Each week, participants in the MI-alone group will complete an activity related to a health behavior (e.g., thinking about the pros and cons of changing the behavior), then complete a phone session with a study trainer. During the phone session, the trainer will (a) review the prior week's topic, (b) discuss techniques for improving adherence to health behaviors (e.g. tracking activity), and (c) problem-solve barriers and encourage the use of resources. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).

Primary Outcome Measure

Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks [ Time Frame: Measured for 7 days at baseline and 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Jeff C Huffman, MD
[email protected]
617-724-2910

Find similar trials in Boston, MA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Massachusetts General Hospital· Boston, MA

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