Trial Outcomes & Findings for Family Model of Diabetes Self-Management Education in the Marshallese Community (NCT NCT02407132)
NCT ID: NCT02407132
Last Updated: 2019-06-20
Results Overview
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.
COMPLETED
NA
221 participants
Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention
2019-06-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Immediate Post-intervention
STARTED
|
110
|
111
|
|
Immediate Post-intervention
COMPLETED
|
107
|
101
|
|
Immediate Post-intervention
NOT COMPLETED
|
3
|
10
|
|
6 Months Post-intervention
STARTED
|
107
|
101
|
|
6 Months Post-intervention
COMPLETED
|
96
|
92
|
|
6 Months Post-intervention
NOT COMPLETED
|
11
|
9
|
|
12 Months Post-intervention
STARTED
|
96
|
92
|
|
12 Months Post-intervention
COMPLETED
|
83
|
90
|
|
12 Months Post-intervention
NOT COMPLETED
|
13
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Family Model of Diabetes Self-Management Education in the Marshallese Community
Baseline characteristics by cohort
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
52.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
110 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=5 Participants
|
111 participants
n=7 Participants
|
221 participants
n=5 Participants
|
|
HbA1c (%) (unadjusted)
|
10.51 Percent Glycated Hemoglobin (unadjusted)
STANDARD_DEVIATION 2.37 • n=5 Participants
|
10.41 Percent Glycated Hemoglobin (unadjusted)
STANDARD_DEVIATION 2.22 • n=7 Participants
|
10.46 Percent Glycated Hemoglobin (unadjusted)
STANDARD_DEVIATION 2.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-interventionA 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.
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
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
|
10.48 Percent Glycated Hemoglobin (adjusted)
Interval 10.08 to 10.89
|
10.46 Percent Glycated Hemoglobin (adjusted)
Interval 10.07 to 10.86
|
|
Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
Immediate post-intervention
|
9.30 Percent Glycated Hemoglobin (adjusted)
Interval 8.9 to 9.7
|
9.91 Percent Glycated Hemoglobin (adjusted)
Interval 9.5 to 10.32
|
|
Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
6 months post-intervention
|
9.81 Percent Glycated Hemoglobin (adjusted)
Interval 9.4 to 10.23
|
10.26 Percent Glycated Hemoglobin (adjusted)
Interval 9.84 to 10.68
|
|
Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
12 months post-intervention
|
9.61 Percent Glycated Hemoglobin (adjusted)
Interval 9.17 to 10.04
|
10.38 Percent Glycated Hemoglobin (adjusted)
Interval 9.96 to 10.81
|
SECONDARY outcome
Timeframe: Baseline, Immediate post-intervention; 6 months post-intervention; 12 months post-interventionParticipant 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).
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
Baseline
|
30.58 BMI (kg/m²)
Interval 29.6 to 31.55
|
31.46 BMI (kg/m²)
Interval 30.5 to 32.42
|
|
Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
Immediate post-intervention
|
30.66 BMI (kg/m²)
Interval 29.68 to 31.63
|
31.49 BMI (kg/m²)
Interval 30.53 to 32.46
|
|
Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
6 months post-intervention
|
30.97 BMI (kg/m²)
Interval 29.99 to 31.95
|
31.39 BMI (kg/m²)
Interval 30.42 to 32.36
|
|
Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
12 months post-intervention
|
30.78 BMI (kg/m²)
Interval 29.8 to 31.77
|
31.32 BMI (kg/m²)
Interval 30.35 to 32.29
|
SECONDARY outcome
Timeframe: Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-interventionThrough 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.
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
Baseline
|
181.39 Total Cholesterol (mg/dL)
Interval 174.25 to 188.52
|
189.08 Total Cholesterol (mg/dL)
Interval 181.97 to 196.19
|
|
Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
Immediate post-intervention
|
170.15 Total Cholesterol (mg/dL)
Interval 162.92 to 177.37
|
182.64 Total Cholesterol (mg/dL)
Interval 175.35 to 189.94
|
|
Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
6 months post-intervention
|
178.69 Total Cholesterol (mg/dL)
Interval 171.27 to 186.12
|
175.84 Total Cholesterol (mg/dL)
Interval 168.3 to 183.37
|
|
Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
12 months post-intervention
|
170.88 Total Cholesterol (mg/dL)
Interval 163.15 to 178.61
|
180.79 Total Cholesterol (mg/dL)
Interval 173.24 to 188.34
|
SECONDARY outcome
Timeframe: Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-interventionA 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.
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
Baseline
|
36.43 HDL (mg/dL)
Interval 34.47 to 38.39
|
36.99 HDL (mg/dL)
Interval 35.04 to 38.93
|
|
Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
Immediate post-intervention
|
37.53 HDL (mg/dL)
Interval 35.56 to 39.5
|
35.63 HDL (mg/dL)
Interval 33.63 to 37.63
|
|
Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
6 months post-intervention
|
39.34 HDL (mg/dL)
Interval 37.31 to 41.36
|
35.49 HDL (mg/dL)
Interval 33.46 to 37.52
|
|
Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
12 months post-intervention
|
37.50 HDL (mg/dL)
Interval 35.39 to 39.6
|
35.58 HDL (mg/dL)
Interval 33.53 to 37.62
|
SECONDARY outcome
Timeframe: Baseline, 12 months post-interventionThis 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.)
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily
Baseline probability
|
0.44 Probability
Interval 0.31 to 0.57
|
0.53 Probability
Interval 0.39 to 0.65
|
|
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily
12 months probability
|
0.94 Probability
Interval 0.85 to 0.98
|
0.82 Probability
Interval 0.7 to 0.9
|
SECONDARY outcome
Timeframe: Baseline, 12 months post-interventionThis 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.)
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
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 probability
|
0.77 Probability
Interval 0.66 to 0.85
|
0.82 Probability
Interval 0.72 to 0.89
|
|
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
12 months probability
|
0.92 Probability
Interval 0.84 to 0.96
|
0.88 Probability
Interval 0.79 to 0.93
|
SECONDARY outcome
Timeframe: Baseline, 12 Months Post-InterventionThis 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.)
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
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 probability
|
0.49 Probability
Interval 0.39 to 0.59
|
0.47 Probability
Interval 0.37 to 0.57
|
|
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
12 months probability
|
0.53 Probability
Interval 0.42 to 0.64
|
0.49 Probability
Interval 0.38 to 0.6
|
SECONDARY outcome
Timeframe: Baseline, 12 Months Post-InterventionThis 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.)
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months
Baseline probability
|
0.35 Probability
Interval 0.26 to 0.46
|
0.34 Probability
Interval 0.25 to 0.44
|
|
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months
12 months probability
|
0.41 Probability
Interval 0.3 to 0.53
|
0.41 Probability
Interval 0.3 to 0.52
|
SECONDARY outcome
Timeframe: Baseline, 12 Months Post-InterventionThis 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.)
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight
Baseline probability
|
0.14 Probability
Interval 0.09 to 0.23
|
0.07 Probability
Interval 0.03 to 0.13
|
|
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight
12 months probability
|
0.14 Probability
Interval 0.08 to 0.24
|
0.08 Probability
Interval 0.04 to 0.15
|
SECONDARY outcome
Timeframe: Baseline, 12 Months Post-InterventionThis 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.)
Outcome measures
| Measure |
Adapted DSME
n=110 Participants
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
|
Standard DSME
n=111 Participants
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.
|
|---|---|---|
|
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity
Baseline probability
|
0.09 Probability
Interval 0.05 to 0.16
|
0.04 Probability
Interval 0.02 to 0.1
|
|
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity
12 months probability
|
0.09 Probability
Interval 0.04 to 0.17
|
0.05 Probability
Interval 0.02 to 0.12
|
SECONDARY outcome
Timeframe: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-InterventionInformally 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-InterventionInformally 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-InterventionInformally 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.
Outcome measures
Outcome data not reported
Adverse Events
Standard DSME
Family Model DSME
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pearl McElfish
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place