Family Model of Diabetes Self-Management Education in the Marshallese Community

• Sponsor: University of Arkansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT02407132
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 221
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

The investigators will conduct a comparative effectiveness evaluation using a randomized control trial design of a culturally adapted family model of Diabetes Self-Management Education (Adapted DSME) compared with Standard DSME within the Marshallese population. The family model will cover the same concepts as the standard format. However, the family model will incorporate culturally-adapted education and recommendations aimed at engaging family members in the management of the primary participant's diabetes, and family members will be invited to fully participate in the study. By contrast, the standard model provides diabetes self- management education to the diabetic participant only, and the participant's family members do not participate in the classes or any other part of the study. Biometric and survey data will be collected pre-intervention, post-intervention, 6 months post-intervention, and 12 months post-intervention. A qualitative debriefing session will be held for each family between the final DSME session and the 6 month post-intervention to obtain qualitative data regarding the participant's perceptions of the intervention and implementation process.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Behavioral: Adapted DSME; Behavioral: Standard DSME	N/A

Detailed Description

Background and Rationale

The Marshallese population suffers from a significant and disproportionate burden of type 2 diabetes. The rate of type 2 diabetes among the Marshallese is one of the highest of any population group in the world-at least 400% higher than the general US population.1-7 Our systematic review of local, national, and international data found estimates of diabetes in the Marshallese (populations living both in the US and Marshall Islands) ranging from 30% to 50% compared to 8.3% for the US population and 4% worldwide.4-7 Causes for this disparity have not been completely unraveled and are partially embedded in the history of the Marshall Islands. Between 1946 and 1958, the US military tested nuclear weapons on several of the Marshall Islands. People who inhabited the bombed islands and atolls were relocated, but Marshallese living on nearby atolls that were not evacuated experienced nuclear fallout during and after nuclear tests. Because of the nuclear testing, the Atomic Energy Commission lists the Marshall Islands as one of the most contaminated places in the world, and several studies demonstrate ongoing health effects from the nuclear testing.8 The nuclear contamination resulted in significant and long-term changes in diet and lifestyle of the Marshallese.9-12 These changes in diet and lifestyle have contributed to an increased rate of type 2 diabetes.2-5,16-19 The Compact of Free Association between the Republic of the Marshall Islands (RMI) and the US, signed in 1986, permits the US to conduct military activities in the Marshall Islands and also allows Marshallese individuals to come to the US without a visa. The Marshallese population living in the US tripled between 2000 and 2010, with Arkansas having the largest population of Marshallese living outside of the RMI.

Diabetes self-management education (DSME) is an evidence-based model that has been shown to improve glycemic control, reduce diabetic complications, and reduce the cost of managing diabetes. Standard implementation approaches of DSME have not been effective in Marshallese populations, indicating that a unique approach tailored to this population is needed.2-3 Because of the disproportionate burden of diabetes and related complications experienced by this high-risk population, a novel adaptation of the evidence-based DSME model and subsequent testing in a community-based setting are needed.

Using a Community Based Participatory Research (CBPR) approach, we have conducted four focus groups and individual interviews with the Marshallese community to better understand how to best address the well-established need for diabetes education. Through interviews and focus groups, Marshallese participants pointed out that the delivery method and the concept of self-management as an individual experience are problematic components. DSME was designed with a very Western societal approach, which is highly individualistic. The Marshallese have a highly collectivist culture and the idea of -self‖ management is counter to their cultural values. As stakeholders described, -we eat together from one pot. For one person to refuse the food from that one pot is not just inconvenient, it is shameful. It shames the person and the person's family. It is not an acceptable option. We will not do it. The interviewees stated that any changes must be a family change. Incorporating collectivist and family concepts into the delivery mechanism is imperative. Through the interviews and focus groups, the Marshallese community suggested that DSME be implemented within a family model with a family group receiving DSME so that the entire family can benefit and the patient can be supported in their effort to make lifestyle changes. Because ~30-50% of the Marshallese community have type 2 diabetes, this approach could be even more beneficial.

Hypothesis and/or Specific Aims or Objectives

We hypothesize that a culturally adapted DSME implemented in a family model will result in better diabetes management outcomes compared with standard DSME for the Marshallese.

In the family delivery model, a participant is encouraged to invite his/her family members to the diabetes educational sessions. As outlined by stakeholders, the model has several potential benefits. First, patients are empowered to invite the people they define as family and as appropriate for taking part in the sessions with them. Second, the education will engage the patient-defined support unit. Third, given the high-rate of diabetes within the community, it is highly probable that others within the group will have Type 2 diabetes or pre-diabetes and may benefit from the intervention as well.

Our aim is to test an Adapted DSME using a mixed-methods approach. Marshallese participants with type 2 diabetes will be recruited. Those who are assigned to the family model will be asked to invite one to ten adult members of their families to participate in the DSME. Given that ~30-50% of adults in the Marshallese community have type 2 diabetes, and the Marshallese typically have large families, recruitment for this nontraditional model is plausible. Furthermore, the method was designed from input from our CBPR partnership with the Marshallese.

This research is highly translational. It will help bridge the gap between knowledge of an effective DSME intervention and actual implementation of the intervention among a Pacific Islander population with especially high rates of type 2 diabetes and significant health disparities.

Study Design

• Study Type: Interventional
• Actual Enrollment: 221 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Family Model of Diabetes Self-Management Education in the Marshallese Community
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard DSME Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.	Behavioral: Standard DSME; Active Comparator: Standard DSME Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Experimental: Adapted DSME Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Behavioral: Adapted DSME; Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.

Outcome Measures

Primary Outcome Measures

1. Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention. [Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention]

   A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant. The primary outcome measure was change in adjusted mean HbA1c (%) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants. The mean HbA1c values presented here have been adjusted, whereas the mean HbA1c values presented in the Baseline Data section are unadjusted.

Secondary Outcome Measures

1. Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention [Baseline, Immediate post-intervention; 6 months post-intervention; 12 months post-intervention]

   Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb (0.2 kg) using a calibrated digital scale. Height (without shoes) was measured to the nearest 0.5 cm using a stadiometer. Weight and height were used to compute a continuous measure of BMI (kg/m²).

2. Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention. [Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention]

   Through finger prick blood collection, point of care tests were used to test fasting lipids using a commercial lipid panel kit and Cholestech LDX analyzer. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants.

3. Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention. [Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention]

   A commercial lipid panel kit and Cholestech LDX analyzer were used to assess HDL levels. The outcome measure was change in mean HDL from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants.

4. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily [Baseline, 12 months post-intervention]

   This measure assesses whether or not each participant reported checking her/his blood glucose at least daily at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

5. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Seen Doctor or Other Health Professional in Past 12 Months for Diabetes [Baseline, 12 months post-intervention]

   This measure assesses whether or not each participant reported seeing a doctor, nurse, or other health professional for her/his diabetes within the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

6. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Foot Exam by Doctor or Other Health Professional in Past 12 Months [Baseline, 12 Months Post-Intervention]

   This measure assesses whether or not each participant reported having a health professional check her/his feet for any sores or irritations in the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

7. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months [Baseline, 12 Months Post-Intervention]

   This measure assesses whether or not each participant reported having an eye exam in which the pupils were dilated in the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

8. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight [Baseline, 12 Months Post-Intervention]

   This measure assesses whether or not each participant had a normal weight at baseline and 12 months post-intervention as indicated by body mass index (i.e., body mass index between 18.5 to 24.9). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb (0.2 kg) using a calibrated digital scale. Height (without shoes) was measured to the nearest 0.5 cm using a stadiometer. Weight and height were used to compute a continuous measure of BMI (kg/m²). (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

9. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity [Baseline, 12 Months Post-Intervention]

   This measure assesses whether or not each participant reported engaging in 60 minutes or more of vigorous activity per week or 150 minutes or more of moderate activity per week at baseline and 12 months post-intervention. This measure was lightly adapted from the measure of physical activity used here: L. Jiang, S. Chen, B. Zhang, J. Beals, C.M. Mitchell, S.M. Manson, et al. Longitudinal patterns of stages of change for exercise and lifestyle intervention outcomes: an application of latent class analysis with distal outcomes. Prev. Sci., 17 (2016), pp. 398-409. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

10. Change in Mean Fasting Glucose From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention [Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention]

    Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.

11. Change in Mean Low-density Lipoproteins (LDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention [Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention]

    Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.

12. Change in Mean Triglycerides From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention [Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention]

    Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Primary Participant:

• Must be 18 years or older

• Self-reported Diabetes Mellitus Type 2 diagnosis by a health care provider

• Self-reported Marshallese ethnicity or descent

Secondary (Family) Participant:

• Must be 18 years or older

Exclusion Criteria:

• Younger than 18

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences Northwest	Fayetteville	Arkansas	United States	72703

Sponsors and Collaborators

• University of Arkansas
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Peter O Kohler, M.D., University of Arkansas

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 25, 2017

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT02407132
• Other Study ID Numbers: 203482
• First Posted: Apr 2, 2015
• Last Update Posted: Jun 20, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

Participant Flow

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Period Title: Immediate Post-intervention
STARTED	110	111
COMPLETED	107	101
NOT COMPLETED	3	10
Period Title: Immediate Post-intervention
STARTED	107	101
COMPLETED	96	92
NOT COMPLETED	11	9
Period Title: Immediate Post-intervention
STARTED	96	92
COMPLETED	83	90
NOT COMPLETED	13	2

Baseline Characteristics

Arm/Group Title	Adapted DSME	Standard DSME	Total
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.	Total of all reporting groups
Overall Participants	110	111	221
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.4 (11.1)	53.0 (10.6)	52.2 (10.8)
Sex: Female, Male (Count of Participants)
Female	58 52.7%	72 64.9%	130 58.8%
Male	52 47.3%	39 35.1%	91 41.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	110 100%	111 100%	221 100%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	110 100%	111 100%	221 100%
HbA1c (%) (unadjusted) (Percent Glycated Hemoglobin (unadjusted)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent Glycated Hemoglobin (unadjusted)]	10.51 (2.37)	10.41 (2.22)	10.46 (2.29)

Outcome Measures

1. Primary Outcome

Title	Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
Description	A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant. The primary outcome measure was change in adjusted mean HbA1c (%) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants. The mean HbA1c values presented here have been adjusted, whereas the mean HbA1c values presented in the Baseline Data section are unadjusted.
Time Frame	Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline	10.48	10.46
Immediate post-intervention	9.30	9.91
6 months post-intervention	9.81	10.26
12 months post-intervention	9.61	10.38

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	The outcome variable for these analyses is Change in mean HbA1c from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.038
	Comments	The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. 6 months between-arms p-value = 0.139; 12 months between-arms p-value = 0.013. Analyses do not include imputed values.
	Method	Linear mixed effects regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

2. Secondary Outcome

Title	Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
Description	Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb (0.2 kg) using a calibrated digital scale. Height (without shoes) was measured to the nearest 0.5 cm using a stadiometer. Weight and height were used to compute a continuous measure of BMI (kg/m²).
Time Frame	Baseline, Immediate post-intervention; 6 months post-intervention; 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline	30.58	31.46
Immediate post-intervention	30.66	31.49
6 months post-intervention	30.97	31.39
12 months post-intervention	30.78	31.32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	The outcome variable for these analyses is Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.234
	Comments	The p-value above reflects results of between-arms analysis of change in mean BMI from baseline to immediate post-intervention. 6 months between-arms p-value = 0.552; 12 months between-arms p-value = 0.447. Analyses do not include imputed values.
	Method	Linear mixed effects regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

3. Secondary Outcome

Title	Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
Description	Through finger prick blood collection, point of care tests were used to test fasting lipids using a commercial lipid panel kit and Cholestech LDX analyzer. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants.
Time Frame	Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline	181.39	189.08
Immediate post-intervention	170.15	182.64
6 months post-intervention	178.69	175.84
12 months post-intervention	170.88	180.79

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	The outcome variable for these analyses is Change in mean Total Cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	The p-value above reflects results of between-arms analysis of change in mean total chol from baseline to immediate post-intervention. 6 months between-arms p-value=0.598; 12 months between-arms p-value=0.073. Analyses do not include imputed values.
	Method	Linear mixed effects regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

4. Secondary Outcome

Title	Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
Description	A commercial lipid panel kit and Cholestech LDX analyzer were used to assess HDL levels. The outcome measure was change in mean HDL from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants.
Time Frame	Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline	36.43	36.99
Immediate post-intervention	37.53	35.63
6 months post-intervention	39.34	35.49
12 months post-intervention	37.50	35.58

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	The outcome variable for these analyses is Change in mean HDL (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.186
	Comments	The p-value above reflects results of between-arms analysis of mean change in HDL from baseline to immediate post-intervention. 6 months between-arms p-value=0.009; 12 months between-arms p-value=0.201. Analyses do not include imputed values.
	Method	Linear mixed effects regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

5. Secondary Outcome

Title	Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily
Description	This measure assesses whether or not each participant reported checking her/his blood glucose at least daily at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)
Time Frame	Baseline, 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline probability	0.44	0.53
12 months probability	0.94	0.82

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.040
	Comments	The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.
	Method	Mixed effects logistic regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

6. Secondary Outcome

Title	Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Seen Doctor or Other Health Professional in Past 12 Months for Diabetes
Description	This measure assesses whether or not each participant reported seeing a doctor, nurse, or other health professional for her/his diabetes within the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)
Time Frame	Baseline, 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline probability	0.77	0.82
12 months probability	0.92	0.88

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.312
	Comments	The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.
	Method	Mixed Effects Logistic Regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

7. Secondary Outcome

Title	Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Foot Exam by Doctor or Other Health Professional in Past 12 Months
Description	This measure assesses whether or not each participant reported having a health professional check her/his feet for any sores or irritations in the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)
Time Frame	Baseline, 12 Months Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline probability	0.49	0.47
12 months probability	0.53	0.49

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.622
	Comments	The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.
	Method	Mixed effects logistic regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

8. Secondary Outcome

Title	Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months
Description	This measure assesses whether or not each participant reported having an eye exam in which the pupils were dilated in the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)
Time Frame	Baseline, 12 Months Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline probability	0.35	0.34
12 months probability	0.41	0.41

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.957
	Comments	The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.
	Method	Mixed effects logistic regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

9. Secondary Outcome

Title	Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight
Description	This measure assesses whether or not each participant had a normal weight at baseline and 12 months post-intervention as indicated by body mass index (i.e., body mass index between 18.5 to 24.9). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb (0.2 kg) using a calibrated digital scale. Height (without shoes) was measured to the nearest 0.5 cm using a stadiometer. Weight and height were used to compute a continuous measure of BMI (kg/m²). (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)
Time Frame	Baseline, 12 Months Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline probability	0.14	0.07
12 months probability	0.14	0.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.147
	Comments	The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.
	Method	Mixed effects logistic regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

10. Secondary Outcome

Title	Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity
Description	This measure assesses whether or not each participant reported engaging in 60 minutes or more of vigorous activity per week or 150 minutes or more of moderate activity per week at baseline and 12 months post-intervention. This measure was lightly adapted from the measure of physical activity used here: L. Jiang, S. Chen, B. Zhang, J. Beals, C.M. Mitchell, S.M. Manson, et al. Longitudinal patterns of stages of change for exercise and lifestyle intervention outcomes: an application of latent class analysis with distal outcomes. Prev. Sci., 17 (2016), pp. 398-409. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)
Time Frame	Baseline, 12 Months Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapted DSME	Standard DSME
Arm/Group Description	Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Measure Participants	110	111
Baseline probability	0.09	0.04
12 months probability	0.09	0.05

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted DSME, Standard DSME
	Comments	To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.326
	Comments	The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.
	Method	Mixed effects logistic regression
	Comments	Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.

11. Secondary Outcome

Title	Change in Mean Fasting Glucose From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
Description	Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.
Time Frame	Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Change in Mean Low-density Lipoproteins (LDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
Description	Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.
Time Frame	Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Change in Mean Triglycerides From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
Description	Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.
Time Frame	Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	From enrollment to 1 year, 4 months post-enrollment
Adverse Event Reporting Description	Study staff assessed presence of adverse events via regular contact with participants from both study arms throughout the duration of the study.
Arm/Group Title	Standard DSME		Family Model DSME
Arm/Group Description	Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.		Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
All Cause Mortality
	Standard DSME		Family Model DSME
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/111 (0.9%)		3/110 (2.7%)
Serious Adverse Events
	Standard DSME		Family Model DSME
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/111 (0%)		0/110 (0%)
Other (Not Including Serious) Adverse Events
	Standard DSME		Family Model DSME
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/111 (0%)		0/110 (0%)

Limitations/Caveats

We were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides, as participants reported they had not adhered to instructions to fast before data collection events.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.