Trial Outcomes & Findings for Adaptation of a Digital Weight Loss Intervention Promoting Self-regulation for Use in Type 2 Diabetes (NCT NCT03650088)
NCT ID: NCT03650088
Last Updated: 2023-01-13
Results Overview
Weight will be measured on a digital scale
COMPLETED
NA
18 participants
Baseline, Month 3
2023-01-13
Participant Flow
Participants were recruited through emails to individuals identified through medical records, informational emails, and social media posts and enrolled between October 2019 and October 2020 by research staff at the University of North Carolina at Chapel Hill Weight Research Program.
Participant milestones
| Measure |
Weight Loss Intervention
Behavioral weight loss program with digital tools including smartphone app for dietary self-monitoring using a 'traffic light' approach, physical activity tracker, smart scale, and blood glucose monitoring plus with weekly consultation (in person or phone) with an interventionist for behavioral lessons and supports.
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|---|---|
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Overall Study
STARTED
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18
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Overall Study
COMPLETED
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17
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptation of a Digital Weight Loss Intervention Promoting Self-regulation for Use in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Weight Loss Intervention
n=18 Participants
Behavioral weight loss program with digital tools including smartphone app for dietary self-monitoring using a 'traffic light' approach, physical activity tracker, smart scale, and blood glucose monitoring plus with weekly consultation (in person or phone) with an interventionist for behavioral lessons and supports.
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|---|---|
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Age, Continuous
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56.4 years
STANDARD_DEVIATION 5.02 • n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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17 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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7 Participants
n=5 Participants
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Race (NIH/OMB)
White
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11 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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18 Participants
n=5 Participants
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Weight
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94.97 kg
STANDARD_DEVIATION 13.74 • n=5 Participants
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Body Mass Index (BMI)
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34.70 kg/m^2
STANDARD_DEVIATION 4.20 • n=5 Participants
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HbA1c Percent
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6.45 percent of total hemoglobin
STANDARD_DEVIATION 1.20 • n=5 Participants
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Compliance Behavior and Efforts at Diabetes Self-Control
Internal Locus of Control
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26.78 units on a scale
STANDARD_DEVIATION 3.08 • n=5 Participants
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Compliance Behavior and Efforts at Diabetes Self-Control
Chance Locus of Control
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14.44 units on a scale
STANDARD_DEVIATION 4.07 • n=5 Participants
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Compliance Behavior and Efforts at Diabetes Self-Control
Powerful Others Locus of Control
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17.67 units on a scale
STANDARD_DEVIATION 3.76 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Relationships with Medical Professionals
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10.67 units on a scale
STANDARD_DEVIATION 2.59 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Support from Family and Friends
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11.00 units on a scale
STANDARD_DEVIATION 3.41 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Knowledge of the Disease
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10.94 units on a scale
STANDARD_DEVIATION 2.86 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Lifestyle Changes
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8.50 units on a scale
STANDARD_DEVIATION 2.57 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Exercising
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10.61 units on a scale
STANDARD_DEVIATION 2.77 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Self-Monitoring
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10.28 units on a scale
STANDARD_DEVIATION 2.47 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Uncertainty about a Consultation
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4.67 units on a scale
STANDARD_DEVIATION 1.03 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Medication
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5.06 units on a scale
STANDARD_DEVIATION 1.95 • n=5 Participants
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Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Insulin-Use
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5.72 units on a scale
STANDARD_DEVIATION 1.74 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, Month 3Weight will be measured on a digital scale
Outcome measures
| Measure |
Weight Loss Intervention
n=17 Participants
Behavioral weight loss program with digital tools including smartphone app for dietary self-monitoring using a 'traffic light' approach, physical activity tracker, smart scale, and blood glucose monitoring plus with weekly consultation (in person or phone) with an interventionist for behavioral lessons and supports.
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Change in Weight
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-4.54 kg
Standard Deviation 1.01
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SECONDARY outcome
Timeframe: Baseline, Month 3BMI in kg/m\^2
Outcome measures
| Measure |
Weight Loss Intervention
n=17 Participants
Behavioral weight loss program with digital tools including smartphone app for dietary self-monitoring using a 'traffic light' approach, physical activity tracker, smart scale, and blood glucose monitoring plus with weekly consultation (in person or phone) with an interventionist for behavioral lessons and supports.
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|---|---|
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Change in Body Mass Index (BMI)
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-1.66 kg/m^2
Standard Deviation 0.39
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SECONDARY outcome
Timeframe: Baseline, Month 3Population: At follow-up, 11 measurements were performed in clinic; 2 measurements were performed by the participant's Primary Care Provider and a report provided to the research staff; 4 participants had no data (due to COVID-19 restrictions, in person measurements were suspended)
HbA1c will be measured by finger stick in the non-fasting state and analyzed using a point of care analyzer. HBA1c values 5.7 to 6.4% are considered pre-diabetes and 6.5% or higher are considered diabetes.
Outcome measures
| Measure |
Weight Loss Intervention
n=13 Participants
Behavioral weight loss program with digital tools including smartphone app for dietary self-monitoring using a 'traffic light' approach, physical activity tracker, smart scale, and blood glucose monitoring plus with weekly consultation (in person or phone) with an interventionist for behavioral lessons and supports.
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|---|---|
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Change in HbA1c Percent
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-0.3 percentage of total hemoglobin
Standard Deviation 0.08
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SECONDARY outcome
Timeframe: Baseline, Month 3The Diabetes Locus of Control Scale assesses adherence to treatment recommendations for managing Type 2 diabetes; 18 items measured on a 6-point Likert scale where 1 is 'strongly disagree with the statement' and 6 is 'strongly agree with the statement'. Three subscales include internal locus of control (6 items), powerful others locus of control (6 items), and chance locus of control (6 items) and are calculated as the sum of the six subscale item Likert-type responses with a range of 6-36 for each subscale. Higher values indicate higher attribution to the source of control.
Outcome measures
| Measure |
Weight Loss Intervention
n=17 Participants
Behavioral weight loss program with digital tools including smartphone app for dietary self-monitoring using a 'traffic light' approach, physical activity tracker, smart scale, and blood glucose monitoring plus with weekly consultation (in person or phone) with an interventionist for behavioral lessons and supports.
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|---|---|
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Change in Compliance Behavior and Efforts at Diabetes Self-control
Internal Locus of Control
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-0.12 score on a scale
Standard Deviation 1.01
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Change in Compliance Behavior and Efforts at Diabetes Self-control
Chance Locus of Control
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-1.35 score on a scale
Standard Deviation 0.67
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Change in Compliance Behavior and Efforts at Diabetes Self-control
Powerful Others Locus of Control
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0.65 score on a scale
Standard Deviation 0.66
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SECONDARY outcome
Timeframe: Baseline, Month 3The Diabetes Obstacles Questionnaire (DOQ-30) assesses perceived obstacles to diabetes management: 30 items measured on a 5-point Likert-scale where 5 is strongly agree and 1 is strongly disagree. Nine subscales include relationships with medical professionals (4 items), support from friends and family (4 items), knowledge of the disease (4 items), lifestyle changes (4 items), exercising (4 items), self-monitoring (4 items), uncertainty about a consultation (2 items), medication (2 items), and insulin use (2 items). These are calculated as the sum of subscale responses with ranges of 4-20 for 4- item subscales and 2-10 for the 2- item subscales. Higher values indicate worse quality of life.
Outcome measures
| Measure |
Weight Loss Intervention
n=17 Participants
Behavioral weight loss program with digital tools including smartphone app for dietary self-monitoring using a 'traffic light' approach, physical activity tracker, smart scale, and blood glucose monitoring plus with weekly consultation (in person or phone) with an interventionist for behavioral lessons and supports.
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|---|---|
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Relationships with Medical Professionals
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-2.88 score on a scale
Standard Deviation 0.70
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Support from Friends and Family
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-2.54 score on a scale
Standard Deviation 0.61
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Knowledge of the Disease
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-4.06 score on a scale
Standard Deviation 0.77
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Lifestyle Changes
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-1.24 score on a scale
Standard Deviation 0.68
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Exercising
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-3.06 score on a scale
Standard Deviation 0.66
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Self-Monitoring
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-2.29 score on a scale
Standard Deviation 0.57
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Uncertainty about a Consultation
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-1 score on a scale
Standard Deviation 0.30
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Medication
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-0.24 score on a scale
Standard Deviation 0.47
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Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)
Insulin use
|
-0.18 score on a scale
Standard Deviation 0.42
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Adverse Events
Weight Loss Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deborah F. Tate, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place