RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Novel Psychological-behavioral Intervention to Promote Physical Activity in Type 2 Diabetes

Quick Facts

Study Start:2022-10-12
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05420051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of Type 2 Diabetes
  2. * Low physical activity (\<150 minutes/week of moderate to vigorous physical activity)
  1. * Cognitive deficits impeding a participant's ability to provide informed consent or participate
  2. * Medical conditions likely to lead to death within 6 months.
  3. * Pre-existing coronary artery disease
  4. * Moderate-severe depression (Patient Health Questionnaire-9 \[PHQ-9\] score ≥15)
  5. * Use of non-basal insulin
  6. * Inability to participate in physical activity due to another medical condition
  7. * Inability to receive text messages
  8. * Inability to read, write, or speak in English
  9. * Current participation in another intervention or program that has been designed to promote well-being or physical activity

Contacts and Locations

Study Contact

Jeff C Huffman, M.D.
CONTACT
617-724-2910
jhuffman@partners.org

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-12
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2022-10-12
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2