N/A
Completed N=70
A Psychological-behavioral Intervention to Increase Activity in Type 2 Diabetes
Source: ClinicalTrials.gov NCT03164538 ↗Enrolled (actual)
70
Serious AEs
5.7%
Results posted
Feb 2021
Primary outcomePrimary: Number of PP-MI Sessions Completed by Participants — 11 sessions completed
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of PP-MI Sessions Completed by Participants |
11 | — |
| SECONDARY Ease of PP Component |
8.18 | — |
| SECONDARY Ease of MI Component |
8.40 | — |
| SECONDARY Utility of PP Component |
8.78 | — |
| SECONDARY Utility of MI Component |
8.96 | — |
| SECONDARY Change in Moderate-Vigorous Physical Activity |
3.88; -1.21; 2.75; 0.33 | — |
| SECONDARY Change in Physical Activity |
904; -379; 222; -290 | — |
| SECONDARY Change in Sedentary Time |
19.68; 5.78; -11.84; 4.74 | — |
| SECONDARY Change in Positive Affect |
1.29; 0.41; 5.54; 4.21 | — |
| SECONDARY Change in Optimism |
2.54; 0.55; 2.54; 0.43 | — |
| SECONDARY Change in Self-Efficacy for Exercise |
12.50; -9.55; 7.38; -7.81 | — |
| SECONDARY Change in Depression |
-0.11; -0.72; 0.00; 0.46 | — |
| SECONDARY Change in Anxiety |
-1.04; -0.90; -1.00; -0.96 | — |
| SECONDARY Change in Resilience |
-0.07; 0.00; -0.25; 0.64 | — |
| SECONDARY Change in Perceived Social Support |
-1.18; 3.83; 6.25; 5.57 | — |
| SECONDARY Change in Diabetes Self-Care |
0.79; 1.02; 0.97; 1.13 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03164538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.