Trial Outcomes & Findings for Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes (NCT NCT03037528)

NCT ID: NCT03037528

Last Updated: 2023-11-07

Results Overview

Measured with HbA1c

Recruitment status

COMPLETED

Study phase

Target enrollment

112 participants

Primary outcome timeframe

12 months

Results posted on

2023-11-07

Participant Flow

We recruited 112 participants.

In this 2x2x2 design, rather than considering this as an 8-arm trial, we consider this a trial assessing 3 factors at two levels, and we compare each of the 3 factors, rather than comparing the study arms.

Participant milestones

Participant milestones
Measure	Positive Affect, Mindfulness, and Daily Tracking Participants were assigned to Positive affect, Mindfulness, and Daily Tracking	Mindfulness and Daily Tracking Participants were assigned to Mindfulness and Daily Tracking	Positive Affect and Daily Tracking Participants were assigned to Positive Affect and Daily Tracking	Daily Tracking Participants were assigned to Daily Tracking	Positive Affect, Mindfulness, Monthly Tracking Participants were assigned to Positive Affect, Mindfulness, Monthly Tracking	Mindfulness and Monthly Tracking Participants were assigned to Mindfulness and Monthly Tracking	Positive Affect and Monthly Tracking Participants were assigned to Positive Affect and Monthly Tracking	Monthly Tracking Participants were assigned to Monthly Tracking
Overall Study STARTED	15	15	13	14	13	14	15	13
Overall Study COMPLETED	12	12	11	10	8	7	9	5
Overall Study NOT COMPLETED	3	3	2	4	5	7	6	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positive Affect, Mindfulness, and Daily Tracking n=15 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. Positive Affect, Mindfulness, and Daily Tracking: positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily.	Mindfulness and Daily Tracking n=15 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily.	Positive Affect and Daily Tracking n=13 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (daily): Participants will be asked to track their diet daily.	Daily Tracking n=14 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (daily): Participants will be asked to track their diet daily.	Positive Affect, Mindfulness, Monthly Tracking n=13 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Mindfulness and Monthly Tracking n=14 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Positive Affect and Monthly Tracking n=15 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Monthly Tracking n=13 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Total n=112 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 10.7 • n=5 Participants	50.2 years STANDARD_DEVIATION 8.9 • n=7 Participants	53.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	54.9 years STANDARD_DEVIATION 11.0 • n=4 Participants	55.9 years STANDARD_DEVIATION 6.6 • n=21 Participants	55.9 years STANDARD_DEVIATION 9.6 • n=8 Participants	58.0 years STANDARD_DEVIATION 7.0 • n=8 Participants	53.0 years STANDARD_DEVIATION 11.1 • n=24 Participants	54.1 years STANDARD_DEVIATION 9.6 • n=42 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=8 Participants	11 Participants n=8 Participants	10 Participants n=24 Participants	83 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	29 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants	13 Participants n=21 Participants	14 Participants n=8 Participants	14 Participants n=8 Participants	13 Participants n=24 Participants	111 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	9 Participants n=21 Participants	13 Participants n=8 Participants	9 Participants n=8 Participants	9 Participants n=24 Participants	81 Participants n=42 Participants
Race/Ethnicity, Customized African American	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	27 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	6 Participants n=42 Participants

PRIMARY outcome

Timeframe: 12 months

Measured with HbA1c

Outcome measures

Outcome measures
Measure	Positive Affect, Mindfulness, and Daily Tracking n=12 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily.	Mindfulness and Daily Tracking n=12 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily.	Positive Affect and Daily Tracking n=11 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (daily): Participants will be asked to track their diet daily.	Daily Tracking n=10 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (daily): Participants will be asked to track their diet daily.	Positive Affect, Mindfulness, Monthly Tracking n=8 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Mindfulness and Monthly Tracking n=7 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Positive Affect and Monthly Tracking n=9 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Monthly Tracking n=5 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (monthly): Participants will be asked to track their diet monthly.
Glycemic Control	-.46 change in units of percents Standard Deviation 1.20	-.93 change in units of percents Standard Deviation 1.14	-.46 change in units of percents Standard Deviation 1.99	-.23 change in units of percents Standard Deviation 1.27	-1.23 change in units of percents Standard Deviation 2.93	-1.34 change in units of percents Standard Deviation 0.61	-.58 change in units of percents Standard Deviation 0.48	-.64 change in units of percents Standard Deviation 0.78

SECONDARY outcome

Timeframe: 12 months

Measured with percent change in body weight

Outcome measures

Outcome measures
Measure	Positive Affect, Mindfulness, and Daily Tracking n=12 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily.	Mindfulness and Daily Tracking n=12 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily.	Positive Affect and Daily Tracking n=12 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (daily): Participants will be asked to track their diet daily.	Daily Tracking n=11 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (daily): Participants will be asked to track their diet daily.	Positive Affect, Mindfulness, Monthly Tracking n=8 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Mindfulness and Monthly Tracking n=8 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Positive Affect and Monthly Tracking n=9 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (monthly): Participants will be asked to track their diet monthly.	Monthly Tracking n=5 Participants Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (monthly): Participants will be asked to track their diet monthly.
Weight Loss	-5.69 change in percent Standard Deviation 8.03	-9.60 change in percent Standard Deviation 7.16	-10.00 change in percent Standard Deviation 14.80	-5.25 change in percent Standard Deviation 5.94	-9.14 change in percent Standard Deviation 8.33	-9.85 change in percent Standard Deviation 11.28	-10.05 change in percent Standard Deviation 10.27	-3.84 change in percent Standard Deviation 4.92

SECONDARY outcome

Timeframe: 12 months

Measured with Patient Health Questionnaire-8. Eight items, each of which is scored 0 to 3, for a 0 to 24 severity score, with higher being a worse outcome.