Trial Outcomes & Findings for Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients (NCT NCT03039569)

NCT ID: NCT03039569

Last Updated: 2019-06-19

Results Overview

An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: Three months
• Results posted on: 2019-06-19

Participant Flow

Participant milestones

Measure	Text Messaging Participants received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). Text messaging: The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise"). The control group did not receive text messages	Control Participants did not receive text message intervention. This is the measurement-only group
Overall Study STARTED	40	39
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	Text Messaging Participants received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). Text messaging: The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise"). The control group did not receive text messages	Control Participants did not receive text message intervention. This is the measurement-only group
Overall Study Lost to Follow-up	5	4

Baseline Characteristics

Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients

Baseline characteristics by cohort

Measure	Text Messaging n=40 Participants Intervention group received three text messages per week for 12 weeks	Control n=39 Participants Control group did not receive text messages	Total n=79 Participants Total of all reporting groups
Age, Customized	58.8 years STANDARD_DEVIATION 10.6 • n=5 Participants	55.7 years STANDARD_DEVIATION 12.2 • n=7 Participants	56.9 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized White	33 Participants n=5 Participants	36 Participants n=7 Participants	69 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Three months

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Self-Care Activities: Healthy Eating Baseline	4.23 days/week (min: 0 days; Max: 7 days) Standard Error 0.38	4.67 days/week (min: 0 days; Max: 7 days) Standard Error 0.40
Self-Care Activities: Healthy Eating post-intervention	4.61 days/week (min: 0 days; Max: 7 days) Standard Error 0.40	4.60 days/week (min: 0 days; Max: 7 days) Standard Error 0.41

PRIMARY outcome

Timeframe: Three months

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Diabetes Self-care Activity: Exercise Baseline	5.13 days/week (min: 0 days; Max: 7 days) Standard Error 0.62	4.91 days/week (min: 0 days; Max: 7 days) Standard Error 0.66
Diabetes Self-care Activity: Exercise post-intervention	4.48 days/week (min: 0 days; Max: 7 days) Standard Error 0.66	4.25 days/week (min: 0 days; Max: 7 days) Standard Error 0.69

PRIMARY outcome

Timeframe: three months

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Self-care Activity: Blood Glucose Testing Baseline	5.09 days/ week (min: 0 days; max: 7 days)) Standard Error 0.64	5.93 days/ week (min: 0 days; max: 7 days)) Standard Error 0.69
Self-care Activity: Blood Glucose Testing post-intervention	5.27 days/ week (min: 0 days; max: 7 days)) Standard Error 0.68	5.63 days/ week (min: 0 days; max: 7 days)) Standard Error 0.70

PRIMARY outcome

Timeframe: three months

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

Self-report survey question (days over the last seven days)

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Self-care Activity: Medication Adherence Baseline	5.75 day/week (min: 0 days; max 7 days) Standard Error 0.22	5.83 day/week (min: 0 days; max 7 days) Standard Error 0.23
Self-care Activity: Medication Adherence post-intervention	5.73 day/week (min: 0 days; max 7 days) Standard Error 0.23	5.67 day/week (min: 0 days; max 7 days) Standard Error 0.24

PRIMARY outcome

Timeframe: three months

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

Average of four self-report survey questions of the category (days over the last seven days)

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Self-care Activity: Foot Care Baseline	4.17 day/week (min: 0 days; max 7 days) Standard Error 0.41	4.22 day/week (min: 0 days; max 7 days) Standard Error 0.45
Self-care Activity: Foot Care post-intervention	4.89 day/week (min: 0 days; max 7 days) Standard Error 0.44	4.18 day/week (min: 0 days; max 7 days) Standard Error 0.45

PRIMARY outcome

Timeframe: Three months

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

Self report survey question (days/week)

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Eat >= 5 Servings Fruit and Vegetables	4.1 day/week (min: 0 days; max 7 days) Standard Error 0.4	4.0 day/week (min: 0 days; max 7 days) Standard Error 0.3

SECONDARY outcome

Timeframe: Three months

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

Self-report hemoglobin for diabetes status

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Self-report Hemoglobin A1C Baseline	7.9 percentage of glycated HB in blood Standard Error 0.3	8.5 percentage of glycated HB in blood Standard Error 0.3
Self-report Hemoglobin A1C post-intervention	7.6 percentage of glycated HB in blood Standard Error 0.3	8.0 percentage of glycated HB in blood Standard Error 0.3

SECONDARY outcome

Timeframe: Three months

Population: Chi-square

Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Frequency of Concern of CVD Event Baseline · Never/rare concern	28 Participants	26 Participants
Frequency of Concern of CVD Event Baseline · Sometimes concern	9 Participants	10 Participants
Frequency of Concern of CVD Event Baseline · Always concern	3 Participants	3 Participants
Frequency of Concern of CVD Event Baseline · Not answer	0 Participants	0 Participants
Frequency of Concern of CVD Event post-intervention · Never/rare concern	24 Participants	29 Participants
Frequency of Concern of CVD Event post-intervention · Sometimes concern	7 Participants	5 Participants
Frequency of Concern of CVD Event post-intervention · Always concern	4 Participants	1 Participants
Frequency of Concern of CVD Event post-intervention · Not answer	5 Participants	4 Participants

SECONDARY outcome

Timeframe: One month

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

A self-report food frequency questionnaire over the past month

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Total Carbohydrate Baseline	126 gram/day Standard Error 10	111 gram/day Standard Error 10
Total Carbohydrate post-intervention	102 gram/day Standard Error 11	100 gram/day Standard Error 11

SECONDARY outcome

Timeframe: Three months

Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.

A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity Baseline	2112 MET minutes/week Standard Error 1451	1042 MET minutes/week Standard Error 1430
Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity post-intervention	3163 MET minutes/week Standard Error 1555	405 MET minutes/week Standard Error 1532

SECONDARY outcome

Timeframe: Three months

Population: Chi-square

Self report survey question

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years Baseline · No or low concern	24 Participants	23 Participants
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years Baseline · Somewhat concern	13 Participants	11 Participants
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years Baseline · Highly concern	3 Participants	5 Participants
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years Baseline · Not answer	0 Participants	0 Participants
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years post-intervention · No or low concern	19 Participants	24 Participants
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years post-intervention · Somewhat concern	11 Participants	8 Participants
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years post-intervention · Highly concern	5 Participants	3 Participants
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years post-intervention · Not answer	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Three months

Population: Chi-square

Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime

Outcome measures

Measure	Text Messaging n=40 Participants Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).	Control n=39 Participants Participants will not receive text message intervention. This is the measurement-only group
Degree of Concern of CVD Event in Lifetime Baseline · No concern/low concern	17 Participants	12 Participants
Degree of Concern of CVD Event in Lifetime Baseline · Somewhat concern	15 Participants	20 Participants
Degree of Concern of CVD Event in Lifetime Baseline · highly concern	8 Participants	7 Participants
Degree of Concern of CVD Event in Lifetime Baseline · Not answer	0 Participants	0 Participants
Degree of Concern of CVD Event in Lifetime post-intervention · No concern/low concern	12 Participants	13 Participants
Degree of Concern of CVD Event in Lifetime post-intervention · Somewhat concern	14 Participants	13 Participants
Degree of Concern of CVD Event in Lifetime post-intervention · highly concern	9 Participants	9 Participants
Degree of Concern of CVD Event in Lifetime post-intervention · Not answer	5 Participants	4 Participants

Adverse Events

Text Messaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Weiwen Chai

University of Nebraska-Lincoln

Phone: 402-472-7822

Email: wchai2@unl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place