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

NCT03164538 | Completed Results DMC

• 1 other identifier: 2017P001113
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Ease of PP Component

  Weeks 1-16

• Ease of MI Component

  Weeks 1-16

• Utility of PP Component

  Weeks 1-16

• Utility of MI Component

  Weeks 1-16

• Change in Moderate-Vigorous Physical Activity

  Change from Baseline to 16 weeks, and Baseline to 24 weeks

Other Outcomes (9)

• Change in Medication Adherence

  Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

• Change in Self-Reported Physical Activity

  Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

• Change in Physical Function

  Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Study Arms (2)

Positive Psychology + Motivational Interviewing

EXPERIMENTAL

Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.

Behavioral: Positive Psychology + Motivational Interviewing

Diabetes Education

ACTIVE COMPARATOR

Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet).

Behavioral: Diabetes Education

Interventions

Positive Psychology + Motivational Interviewing BEHAVIORAL

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).

Positive Psychology + Motivational Interviewing

Diabetes Education BEHAVIORAL

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.

Diabetes Education

Eligibility Criteria

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

You may qualify if:

• 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.
• 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).

You may not qualify if:

• Cognitive impairment precluding consent or meaningful participation.
• Lack of phone availability.
• Inability to read/write in English.
• Additional medical conditions (e.g., severe arthritis) that preclude physical activity.
• Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac rehabilitation), or other clinical trials.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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

Results Point of Contact

• Title: Dr. Jeff Huffman
• Organization: Massachusetts General Hospital

JHUFFMAN@mgh.harvard.edu

617-724-2910

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Chief of Psychiatry for Clinical Services

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: July 25, 2017
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)