N/A
Completed N=60
A Psychological-behavioral Intervention for Physical Activity in Type 2 Diabetes
Type2 Diabetes
Source: ClinicalTrials.gov NCT03150199 ↗
Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Mar 2020
Primary outcomePrimary: Number of PP-MI Sessions Completed by Participants — 7.4 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 versus a motivational interviewing (MI) health education 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 |
7.4 | — |
| SECONDARY Ease of PP Component |
8.6 | — |
| SECONDARY Ease of MI Component |
8.5 | — |
| SECONDARY Utility of PP Component |
8.8 | — |
| SECONDARY Utility of MI Component |
8.6 | — |
| SECONDARY Change in Moderate-Vigorous Physical Activity |
15.72; 2.26; 10.05; 2.47 | — |
| SECONDARY Change in Physical Activity |
1848; 273; 969; 171 | — |
| SECONDARY Change in Sedentary Time |
-2.66; -2.95; 2.83; -6.42 | — |
| SECONDARY Change in Positive Affect |
3.36; 0.13; 5.80; 2.61 | — |
| SECONDARY Change in Optimism |
1.36; 1.00; 1.03; 1.61 | — |
| SECONDARY Change in Self-Efficacy for Exercise |
7.18; -3.00; 6.93; -7.89 | — |
| SECONDARY Change in Depression |
-0.54; -0.97; -0.83; -0.07 | — |
| SECONDARY Change in Anxiety |
-0.79; -0.73; -0.27; -0.57 | — |
| SECONDARY Change in Resilience |
-0.43; -0.43; 0.37; -0.32 | — |
| SECONDARY Change in Perceived Social Support |
0.68; -1.77; 3.13; 0.36 | — |
| SECONDARY Change in Diabetes Self-Care |
0.91; 0.93; 0.87; 1.11 | — |
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 (NCT03150199). 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.