Boosting Emotions & Happiness in Outpatients Living With Diabetes: Phase I

NCT03001999 | Completed DMC

• 1 other identifier: 2016P002523
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of this study is to examine the feasibility, acceptability, and preliminary 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; Emotions; Patient Compliance

Keywords

Diabetes; Positive Psychology; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Feasibility of recruitment procedures

  Feasibility will be measured by rates of enrollment per month.

  Change between baseline and 16 weeks

• Feasibility of study procedures

  Feasibility will also be measured by rates of dropout (%of total enrolled).

  Change between baseline and 16 weeks

Secondary Outcomes (12)

• Feasibility of intervention exercises

  Change between baseline and 16 weeks

• Ease of intervention

  Change between baseline and 16 weeks

• Utility of intervention

  Change between baseline and 16 weeks

• Moderate-Vigorous Physical activity

  Change between baseline and 16 weeks

• Sedentary Time

  Change between baseline and 16 weeks

Other Outcomes (10)

• Changes in T2D medication adherence

  Baseline and 16 weeks

• Changes in IPAQ Scores

  Baseline and 16 weeks

• Changes in PF-20 Scores

  Baseline and 16 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Participants will all undergo a 16-week PP-MI health behavior intervention.

Behavioral: PP-MI health behavior intervention

Interventions

PP-MI health behavior intervention BEHAVIORAL

The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. Various goal setting exercises will appear in each of the 14 study sessions.

Intervention Arm

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 be diagnosed with T2D, with diagnosis for at least 1 year, confirmed by their diabetes clinician or medical record review. Consistent with American Diabetes Association (ADA) criteria for T2D, participants must have HbA1c \[A1C\] of at least 6.5% within the last 6 months. The investigators will exclude patients with A1C\>9% given that patients in this range will likely have more extreme nonadherence and/or require ongoing treatment adjustment, increasing the heterogeneity of this sample for this pilot project. If patients appear otherwise eligible, but do not have an A1C value within 6 months, they will be required to have a baseline A1C value of 6.5-9%.
• Low physical activity. The investigators will define low physical activity as ≤75 minutes/week of MVPA (representing ≤40% of ADA recommendations for moderate or greater intensity aerobic physical activity totaling 150 minutes per week). This cutoff allows adequate room for improvement on this key outcome. As an initial screen, the investigators will use a modified version of the International Physical Activity Questionnaire (IPAQ) which has been extensively used/validated in medical cohorts, including T2D. Patients will complete the modified IPAQ regarding their activity in the past week (or a typical week, if the past 7 days atypical) to assess number of minutes spent performing MVPA. Patients reporting ≤60 minutes/week of MVPA will then wear accelerometers for 7 days to confirm low physical activity.

You may not qualify if:

• Cognitive impairment precluding consent or meaningful participation, assessed using a six-item screen developed for this purpose.
• Lack of phone availability.
• Inability to read/write in English.
• Additional medical conditions (e.g., severe arthritis, chronic pulmonary obstructive disease, class III or IV heart failure) 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
• American Diabetes Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Millstein RA, Golden J, Healy BC, Amonoo HL, Harnedy LE, Carrillo A, Celano CM, Huffman JC. Latent growth curve modeling of physical activity trajectories in a positive-psychology and motivational interviewing intervention for people with type 2 diabetes. Health Psychol Behav Med. 2022 Aug 4;10(1):713-730. doi: 10.1080/21642850.2022.2104724. eCollection 2022.

  PMID: 35957957 DERIVED

• Zambrano J, Celano CM, Chung WJ, Massey CN, Feig EH, Millstein RA, Healy BC, Wexler DJ, Park ER, Golden J, Huffman JC. Exploring the feasibility and impact of positive psychology-motivational interviewing interventions to promote positive affect and physical activity in type 2 diabetes: design and methods from the BEHOLD-8 and BEHOLD-16 clinical trials. Health Psychol Behav Med. 2020;8(1):398-422. doi: 10.1080/21642850.2020.1815538. Epub 2020 Sep 14.

  PMID: 33763296 DERIVED

• Feig EH, Harnedy LE, Celano CM, Huffman JC. Increase in Daily Steps During the Early Phase of a Physical Activity Intervention for Type 2 Diabetes as a Predictor of Intervention Outcome. Int J Behav Med. 2021 Dec;28(6):834-839. doi: 10.1007/s12529-021-09966-0. Epub 2021 Feb 11.

  PMID: 33575971 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Patient Compliance; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Psychiatry

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)