A Psychological-behavioral Intervention to Increase Activity in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— BEHOLD-16  

Official title:

A Psychological-behavioral Intervention to Increase Activity in Type 2 Diabetes: a 16-week Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164538
• Other study ID #: 2017P001113
• Status: Completed
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: October 10, 2019

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The focus of this study is to examine the feasibility, acceptability, and impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention in a group of patients with type 2 diabetes (T2D).

Description:

The investigators will compare a combined positive psychology and motivational interviewing (PP-MI) intervention that is adapted for patients with T2D to a diabetes education intervention (control) in a randomized controlled trial. The investigators will enroll 70 participants, who will be randomized to either a 16-week PP-MI health behavior intervention or an 16-week diabetes education intervention.

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

1. Examine the feasibility and acceptability of a 16-week, telephone-delivered health behavior intervention utilizing PP exercises and MI with systematic goal-setting.

2. Determine whether the PP-MI intervention leads to greater increases in physical activity than the education intervention in T2D patients.

3. Explore the impact of the PP-MI intervention on other psychological, behavioral, and medical outcomes, compared to the education intervention.

Participants will undergo an initial screening visit during which they will meet with study staff in person. At this visit, study eligibility will be confirmed, and eligible and willing participants will be enrolled. Following enrollment, participants will complete self-report measures, and vital signs and A1c will be measured. They then will take home and wear an accelerometer for one week, to measure baseline physical activity.

Baseline information about enrolled participants will be obtained from the participants, care providers, and the electronic medical record as required for characterization of the population. This information will include data regarding medical history (type 2 diabetes mellitus), current medical variables (conditions affecting physical activity), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).

Participants will undergo a second in-person visit once adequate baseline physical activity data has been obtained. In this visit, accelerometer data will be reviewed to ensure that adequate baseline activity was captured. If so, participants will be randomized to either the PP-MI or diabetes education condition, then begin the study intervention. During this second in-person visit, participants will receive either a PP-MI or diabetes education treatment manual, depending on randomization.

For the PP-MI intervention:

For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. At subsequent sessions, participants will review the prior week's PP exercise and learn about a new exercise, then will review the prior week's physical activity goal and set a new one.

For the diabetes education intervention:

Each week, participants will learn about a different health behavior topic related to diabetes health. This includes information about diabetes self-monitoring, medication adherence, having a heart-healthy diet, and being physically active.

Participants will complete the remaining sessions by phone approximately weekly over the next 16 weeks. Phone sessions will last approximately 30 minutes, with PP-MI and physical activity assignments completed between phone sessions. PP and MI will be delivered step-wise within sessions (rather than intertwined) based on our experience, participant feedback, and pilot work. If a week is missed, the session will not be skipped, but rather the intervention will be completed sequentially (with participants who miss weeks then missing the final sessions), with the exception of the final visit, which skips to Planning for the Future in all cases.

Participants will undergo an in-person follow-up assessment at 16 weeks. At this session, participants will repeat self-report assessments that were administered at baseline. Vital signs and a blood sample will again be collected at this in-person visit. Prior to this assessment, participants will wear an accelerometer for 7 days to measure physical activity. Participants will also undergo a phone follow-up assessment at 24 weeks. During this session over the phone, participants will repeat self-report assessments that were administered at baseline. Finally, prior to this follow-up, participants will wear another accelerometer for 7 days to measure physical activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. T2D. Eligible patients will meet American Diabetes Association (ADA) criteria for T2D (e.g., HbA1c [A1C] =6.5%, fasting glucose =126 mg/d), with diagnosis confirmed by their diabetes clinician and/or medical record review.

2. Low physical activity. Low physical activity will be defined as =150 minutes/week of MVPA (corresponding to ADA recommendations for moderate or greater intensity aerobic physical activity). Physical activity will be measured using a brief questionnaire adapted from the International Physical Activity Questionnaire (IPAQ).

Exclusion Criteria:

1. Cognitive impairment precluding consent or meaningful participation.

2. Lack of phone availability.

3. Inability to read/write in English.

4. Additional medical conditions (e.g., severe arthritis) that preclude physical activity.

5. Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac rehabilitation), or other clinical trials.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Positive Psychology + Motivational Interviewing
Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions. PP and MI components will be delivered stepwise within sessions (rather than intertwined).
• Diabetes Education
Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.

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 in Medication Adherence	Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 16 weeks and 24 weeks. Higher scores indicate greater levels of medication adherence.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Other	Change in Self-Reported Physical Activity	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. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Other	Change in Physical Function	Measured by the 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS), a well-validated measure of physical function that is highly responsive to changes in a patient's physical function status (Range: 20-100). Higher scores indicate better physical function.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Other	Change in Pain-Related Disability	Measured by the Pain Disability Index (PDI), a well-validated measure of the extent to which pain interferes with different daily activities (Range 0-70). Higher scores indicate greater interference from pain.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Other	Change in Weight	Measured during in-person visit at baseline and post-intervention.	Change from Baseline to Week 16
Other	Change in Body Mass Index (BMI)	Measured during in-person visit at baseline and post-intervention.	Change from Baseline to Week 16
Other	Change in Blood Pressure (Systolic)	Measured during in-person visit at baseline and post-intervention.	Change from Baseline to Week 16
Other	Change in Blood Pressure (Diastolic)	Measured during in-person visit at baseline and post-intervention.	Change from Baseline to Week 16
Other	Change in Hemoglobin A1c	Measured during in-person visit at baseline and post-intervention.	Change from Baseline to Week 16
Primary	Number of PP-MI Sessions Completed by Participants	Measured by number of PP-MI sessions completed by participants in the PP-MI group.	16 weeks
Secondary	Ease of PP Component	Participants in the PP-MI group will provide ratings of ease after each PP exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.	Weeks 1-16
Secondary	Ease of MI Component	Participants in the PP-MI group will provide ratings of ease after each MI exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.	Weeks 1-16
Secondary	Utility of PP Component	Participants in the PP-MI group will provide ratings of utility after each PP exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.	Weeks 1-16
Secondary	Utility of MI Component	Participants in the PP-MI group will provide ratings of utility after each MI exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.	Weeks 1-16
Secondary	Change in Moderate-Vigorous Physical Activity	ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 16 weeks, and 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.	Change from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Physical Activity	Measured by Actigraph accelerometer, in number of steps per day.	Change from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Sedentary Time	Measured by Actigraph accelerometer, in minutes per day.	Change from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Positive Affect	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 medical illnesses, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of positive affect.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Optimism	Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of optimism.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Self-Efficacy for Exercise	Measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assess self-efficacy barriers to exercise (Range: 0-90). Higher scores indicate higher efficacy expectations in relation to exercising. This was measured at Baseline, Week 16, and Week 24.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Depression	The Hospital Anxiety and Depression Scale (HADS)-depression subscale was 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: 0-21). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of depression.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Anxiety	The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was 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). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of anxiety.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Resilience	Measured by the Brief Resilience Scale (BRS), a reliable scale which assesses a person's ability to recover from stress despite adversity (Range: 6-30). Higher scores indicate more resilience.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Perceived Social Support	Measured by the Multidimensional Scale of Perceived Social Support (MSPSS), a scale that measures subjectively reported social support (Range: 12-84). Higher scores indicate more subjectively reported social support.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Secondary	Change in Diabetes Self-Care	Measured by 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 diabetes self-care activities.	Change in score from Baseline to 16 weeks, and Baseline to 24 weeks