Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05420051

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Jeff C Huffman, MD

CONTACT

[email protected]

617-724-2910

About this study

The investigators are proposing a study that will focus on testing the efficacy of a PP-MI intervention, with additional twice text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks) in individuals with type 2 diabetes. The investigators will enroll 280 type 2 diabetes patients, who will take part in either an 8-week intervention (with 16 weeks of supplemental text messages) or an attention-matched, MI-alone condition.

In this project, the investigators hope to do the following:

  • Examine the efficacy of an 8-week, phone-delivered PP-MI intervention for individuals with type 2 diabetes on physical activity-related outcomes, as compared to the MI-alone condition.
  • Assess PP-MI's impact on psychological measures (e.g., positive affect [key secondary outcome]), diabetes self-care, function, glycemic control, and cardiometabolic risk, compared to MI alone.
  • Examine causal mediation of PP-MI's effects on MVPA at 16 weeks by positive affect (primary hypothesized mediator) and other psychological/cognitive variables across our theoretical model.

Participants will be adult outpatients with type 2 diabetes. They will attend an in-person visit to provide informed consent and complete baseline outcome measures, then will wear an accelerometer to monitor their physical activity for one week to obtain information about baseline activity levels. Upon confirmation of low moderate to vigorous physical activity, participants will be randomized to receive the PP-MI intervention or the MI-alone intervention.

Participants in both groups will be provided a treatment manual, an activity tracker, and other treatment materials. The intervention will be introduced, and the first exercise will be assigned.

Participants will complete eight weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.

Participants will receive twice weekly text messages throughout the intervention (Weeks 1-8) and initial follow-up period (Weeks 9-16). In the PP-MI condition, these messages will focus on the PP activity and physical activity, while those in the MI-alone condition will focus on physical activity and other health behaviors. During Weeks 9-16, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and physical activity, while those in the MI-alone condition will receive fixed text messages related to engagement in health behaviors.

At Weeks 8, 16, 24, and 52, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. During these study visits, participants will complete outcome assessments and have a blood sample taken.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Measured for 7 days at baseline and 16 weeks

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

Secondary outcomes

  1. Change from Baseline Overall Activity at 16 weeks

    Time frame: Measured for 7 days at baseline and 16 weeks

    Overall activity will be measured via an accelerometer and recorded in mean steps/day.

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

    Time frame: Baseline, 16 weeks

    The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.

Other outcomes

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

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

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

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

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

    Overall activity will be measured via an accelerometer and recorded in mean steps/day.

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

    Time frame: Baseline, 8 weeks, 24 weeks, 52 weeks

    The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.

  4. Change in optimism (Life Orientation Test - Revised [LOT-R])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of dispositional optimism.

  5. Change in depressive symptoms (Patient Health Questionnaire [PHQ-9])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-27). Higher scores indicate higher levels of depression.

  6. Change in anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety.

  7. Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Locus of control will be measured using the 18-item Multidimensional Health Locus of Control scale [MHLC Form C]. Scores on this scale range from 6-36, with higher scores indicating greater internal health locus of control.

  8. Change in perceived social support (Multidimensional Scale of Perceived Social Support [MSPSS])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. Scores on this scale range from 0-84, with higher scores indicating greater perceived social support.

  9. Change in exercise-related self-efficacy (Self-efficacy for Exercise Scale [SEE])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    The Self-efficacy for Exercise Scale will be used to measure exercise self-efficacy. This is a 9-item scale used to assess an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 20+ minutes per session in the future. Scores on this scale range from 0-90, with higher scores indicating greater self-efficacy for exercise.

  10. Change in physical function (PROMIS 20-item Physical Function Short Form [PF-20])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    The PROMIS 20-item short form (PF-20) will be used to assess physical function. Scores on this scale range from 20-100, with higher scores indicating greater physical function.

  11. Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    The SF-12 mental component score will be used to assess mental health-related quality of life (Range: 0-100). Higher scores indicate higher levels of mental health-related quality of life.

  12. Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    The SF-12 physical component score will be used to assess physical health-related quality of life (Range: 0-100). Higher scores indicate higher levels of physical health-related quality of life.

  13. Change in adherence to a diabetes diet (General diet items of the Summary of Diabetes Self-Care Activities [SDSCA])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Measured by the general diet items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate greater adherence.

  14. Change in adherence to fruits, vegetables, and low fat foods (Specific diet items of the Summary of Diabetes Self-Care Activities [SDSCA])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Measured by the specific diet items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate greater adherence.

  15. Change in exercise (Exercise items of the Summary of Diabetes Self-Care Activities [SDSCA])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Measured by the exercise items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more exercise.

  16. Change in frequency of blood glucose testing (Blood glucose testing items of the Summary of Diabetes Self-Care Activities [SDSCA])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Measured by the blood glucose testing items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more frequent blood glucose testing.

  17. Change in foot care (Foot care items of the Summary of Diabetes Self-Care Activities [SDSCA])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Measured by the foot care items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more frequent foot care.

  18. Change in self-reported MVPA (International Physical Activity Questionnaire [IPAQ])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assesses the types of intensity of physical activity that people do as part of their daily lives. Moderate and vigorous intensity activities will be converted to multiples of resting energy expenditure (MET) minutes per week.

  19. Change in self-reported sedentary time (International Physical Activity Questionnaire [IPAQ])

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Measured by the self-report International Physical Activity Questionnaire (IPAQ). Measured in hours per day.

  20. Change in weight (kilograms)

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Weight will be measured during study visits.

  21. Change in body mass index (kilograms per square meter)

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Height and weight will be measured during study visits.

  22. Change in blood pressure (millimeters of mercury)

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Blood pressure (diastolic and systolic) will be measured by trained nurses using a standardized protocol.

  23. Change in hemoglobin A1C (%)

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Blood samples will be obtained at study visits.

  24. Change in low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol (milligrams per deciliter)

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Blood samples will be obtained at study visits.

  25. Change in triglycerides (milligrams per deciliter)

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

    Blood samples will be obtained at study visits.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeff C Huffman, M.D.

CONTACT

[email protected]

617-724-2910

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: BEHOLD

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.