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

NCT05420051 | Recruiting DMC

• 1 other identifier: 2022P000780
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks

  MVPA will be measured via an accelerometer and recorded in mean minutes/day.

  Measured for 7 days at baseline and 16 weeks

Secondary Outcomes (2)

• Change from Baseline Overall Activity at 16 weeks

  Measured for 7 days at baseline and 16 weeks

• Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 16 weeks

  Baseline, 16 weeks

Other Outcomes (25)

• Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 8, 24, and 52 weeks

  Measured for 7 days at baseline, 8 weeks, 24, weeks, and 52 weeks

• Change from Baseline Overall Activity at 8, 24, and 52 weeks

  Measured for 7 days at baseline, 8 weeks, 24, weeks, and 52 weeks

• Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 8, 24, and 52 weeks

  Baseline, 8 weeks, 24 weeks, 52 weeks

Study Arms (2)

Positive Psychology + Motivational Interviewing

EXPERIMENTAL

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).

Behavioral: Positive Psychology + Motivational Interviewing

Motivational Interviewing

ACTIVE COMPARATOR

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).

Behavioral: Motivational Interviewing

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.

Positive Psychology + Motivational Interviewing

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.

Motivational Interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Type 2 Diabetes
• Low physical activity (\<150 minutes/week of moderate to vigorous physical activity)

You may not qualify if:

• Cognitive deficits impeding a participant's ability to provide informed consent or participate
• Medical conditions likely to lead to death within 6 months.
• Pre-existing coronary artery disease
• Moderate-severe depression (Patient Health Questionnaire-9 \[PHQ-9\] score ≥15)
• Use of non-basal insulin
• Inability to participate in physical activity due to another medical condition
• Inability to receive text messages
• Inability to read, write, or speak in English
• Current participation in another intervention or program that has been designed to promote well-being or physical activity

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Psychology, Positive; Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Jeff C Huffman, M.D.

CONTACT

617-724-2910; jhuffman@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Psychiatry Research Program

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: October 12, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: This information will be shared prior to the end of the study funding period.
• Access Criteria: Investigators who are interested in obtaining access to this information will be asked to submit a request to the principal investigator outlining the proposed use of the data and would need to agree to certain conditions (e.g., not attempting to identify individual participants, destroying data once the use of the data is complete) prior to obtaining access.

Locations

US (1)