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

Diabetes Mellitus, Type 2 Clinical Trial

— BEHOLD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420051
• Other study ID #: 2022P000780
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Jeff C Huffman, M.D.
• Phone: 617-724-2910
• Email: jhuffman[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Positive Psychology + Motivational Interviewing
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
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 8, 24, and 52 weeks	MVPA will be measured via an accelerometer and recorded in mean minutes/day.	Measured for 7 days at baseline, 8 weeks, 24, weeks, and 52 weeks
Other	Change from Baseline Overall Activity at 8, 24, and 52 weeks	Overall activity will be measured via an accelerometer and recorded in mean steps/day.	Measured for 7 days at baseline, 8 weeks, 24, weeks, and 52 weeks
Other	Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 8, 24, and 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.	Baseline, 8 weeks, 24 weeks, 52 weeks
Other	Change in optimism (Life Orientation Test - Revised [LOT-R])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in depressive symptoms (Patient Health Questionnaire [PHQ-9])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in perceived social support (Multidimensional Scale of Perceived Social Support [MSPSS])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in exercise-related self-efficacy (Self-efficacy for Exercise Scale [SEE])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in physical function (PROMIS 20-item Physical Function Short Form [PF-20])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in adherence to a diabetes diet (General diet items of the Summary of Diabetes Self-Care Activities [SDSCA])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in adherence to fruits, vegetables, and low fat foods (Specific diet items of the Summary of Diabetes Self-Care Activities [SDSCA])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in exercise (Exercise items of the Summary of Diabetes Self-Care Activities [SDSCA])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in frequency of blood glucose testing (Blood glucose testing items of the Summary of Diabetes Self-Care Activities [SDSCA])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in foot care (Foot care items of the Summary of Diabetes Self-Care Activities [SDSCA])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in self-reported MVPA (International Physical Activity Questionnaire [IPAQ])	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.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in self-reported sedentary time (International Physical Activity Questionnaire [IPAQ])	Measured by the self-report International Physical Activity Questionnaire (IPAQ). Measured in hours per day.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in weight (kilograms)	Weight will be measured during study visits.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in body mass index (kilograms per square meter)	Height and weight will be measured during study visits.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in blood pressure (millimeters of mercury)	Blood pressure (diastolic and systolic) will be measured by trained nurses using a standardized protocol.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in hemoglobin A1C (%)	Blood samples will be obtained at study visits.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol (milligrams per deciliter)	Blood samples will be obtained at study visits.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Other	Change in triglycerides (milligrams per deciliter)	Blood samples will be obtained at study visits.	Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Primary	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	Change from Baseline Overall Activity at 16 weeks	Overall activity will be measured via an accelerometer and recorded in mean steps/day.	Measured for 7 days at baseline and 16 weeks
Secondary	Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 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.	Baseline, 16 weeks