N/A
Completed N=18
Adaptation of a Digital Weight Loss Intervention Promoting Self-regulation for Use in Type 2 Diabetes
Type 2 Diabetes Mellitus · Overweight and Obesity
Source: ClinicalTrials.gov NCT03650088 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Change in Weight — -4.54 kg
Summary
The purpose of this study is to 1) adapt a weight loss app that the Tate team has previously developed to promote PA and diet and adapt them to the needs and perspectives of those with Type 2 Diabetes (T2DM), integrate daily monitoring of BG using continuous monitoring (CGM) and self-monitoring of diet using the simplified system, and develop appropriate displays of data to facilitate comprehension and decision making, 2) develop the modified intervention and, 3) conduct a pilot and feasibility study on short-term impacts of the intervention in overweight adult patients with T2DM not treated with medications in preparation for an R01 submission.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
-4.54 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-1.66 | — |
| SECONDARY Change in HbA1c Percent |
-0.3 | — |
| SECONDARY Change in Compliance Behavior and Efforts at Diabetes Self-control |
-0.12; -1.35; 0.65 | — |
| SECONDARY Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30) |
-2.88; -2.54; -4.06; -1.24; -3.06; -2.29 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Type 2 diabetes managed with lifestyle or pre-diabetes
- HBA1c >= 5.7%
- BMI 25 - 40 kg/m^2
- English speaking and writing
- not adhering the American College of Sports Medicine recommendation of 150 minutes of MVPA/week
- have a smartphone with internet access
Exclusion Criteria
- current participation in another physical activity or weight control program
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4)
- substance abuse or mental health problems that would make it difficult to adhere to the dietary prescription
- moving out of the area during the study period
- unable to attend weekly sessions
- diagnosis of an eating disorder such as bulimia or anorexia
- currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
Data sourced from ClinicalTrials.gov (NCT03650088). 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.