Trial Outcomes & Findings for Indigenous Supported Agriculture "Go Healthy" (NCT NCT05773833)
NCT ID: NCT05773833
Last Updated: 2026-03-18
Results Overview
Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
580 participants
Primary outcome timeframe
Baseline and 16-week follow-up
Results posted on
2026-03-18
Participant Flow
445 adults and 135 children consented and were enrolled into the study (total participants; n=580). After individual-level enrollment and consent, we administered baseline data collection to all participants. Randomization occurred on the household-level and did not occur until after baseline data collection was complete and we were able to tally household numbers for randomization. Among the 580 that signed consent forms, we could not contact 18 participants to complete baseline demographics.
Unit of analysis: Households
Participant milestones
| Measure |
Intervention
Households that received the "Go Healthy" program
|
Control
Households that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|
|
Overall Study
STARTED
|
277 148
|
285 150
|
|
Overall Study
Adults - Started
|
213 148
|
218 150
|
|
Overall Study
Children - Started
|
64 32
|
67 33
|
|
Overall Study
Adults - Completed
|
192 134
|
208 146
|
|
Overall Study
Children - Completed
|
43 21
|
51 25
|
|
Overall Study
COMPLETED
|
235 134
|
259 146
|
|
Overall Study
NOT COMPLETED
|
42 14
|
26 4
|
Reasons for withdrawal
| Measure |
Intervention
Households that received the "Go Healthy" program
|
Control
Households that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Moved out of Osage Nation
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
38
|
22
|
Baseline Characteristics
Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
Baseline characteristics by cohort
| Measure |
Intervention - Adult
n=213 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=218 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
n=64 Participants
Children of individuals that received the "Go Healthy" program
|
Control - Children
n=67 Participants
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Total
n=562 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-29 years
|
27 Participants
n=213 Participants
|
47 Participants
n=218 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
74 Participants
n=562 Participants
|
|
Age, Customized
30-39 years
|
50 Participants
n=213 Participants
|
43 Participants
n=218 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
93 Participants
n=562 Participants
|
|
Age, Customized
40-49 years
|
46 Participants
n=213 Participants
|
47 Participants
n=218 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
93 Participants
n=562 Participants
|
|
Age, Customized
50-59 years
|
33 Participants
n=213 Participants
|
33 Participants
n=218 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
66 Participants
n=562 Participants
|
|
Age, Customized
60+ years
|
49 Participants
n=213 Participants
|
47 Participants
n=218 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
96 Participants
n=562 Participants
|
|
Age, Customized
3-6 years
|
0 Participants
n=213 Participants
|
0 Participants
n=218 Participants
|
14 Participants
n=64 Participants
|
20 Participants
n=67 Participants
|
34 Participants
n=562 Participants
|
|
Age, Customized
7-10 years
|
0 Participants
n=213 Participants
|
0 Participants
n=218 Participants
|
23 Participants
n=64 Participants
|
16 Participants
n=67 Participants
|
39 Participants
n=562 Participants
|
|
Age, Customized
11-14 years
|
0 Participants
n=213 Participants
|
0 Participants
n=218 Participants
|
15 Participants
n=64 Participants
|
12 Participants
n=67 Participants
|
27 Participants
n=562 Participants
|
|
Age, Customized
15-17 years
|
0 Participants
n=213 Participants
|
0 Participants
n=218 Participants
|
12 Participants
n=64 Participants
|
19 Participants
n=67 Participants
|
31 Participants
n=562 Participants
|
|
Age, Customized
Unknown/Missing
|
8 Participants
n=213 Participants
|
1 Participants
n=218 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
9 Participants
n=562 Participants
|
|
Sex/Gender, Customized
Female
|
133 Participants
n=213 Participants
|
138 Participants
n=218 Participants
|
33 Participants
n=64 Participants
|
39 Participants
n=67 Participants
|
343 Participants
n=562 Participants
|
|
Sex/Gender, Customized
Male
|
77 Participants
n=213 Participants
|
77 Participants
n=218 Participants
|
31 Participants
n=64 Participants
|
28 Participants
n=67 Participants
|
213 Participants
n=562 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=213 Participants
|
0 Participants
n=218 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
1 Participants
n=562 Participants
|
|
Sex/Gender, Customized
Unknown/Missing
|
2 Participants
n=213 Participants
|
3 Participants
n=218 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
5 Participants
n=562 Participants
|
|
Race/Ethnicity, Customized
Native American
|
150 Participants
n=213 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
152 Participants
n=218 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
37 Participants
n=64 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
46 Participants
n=67 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
385 Participants
n=562 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
|
Race/Ethnicity, Customized
Native American + another race
|
43 Participants
n=213 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
42 Participants
n=218 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
27 Participants
n=64 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
19 Participants
n=67 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
131 Participants
n=562 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
|
Race/Ethnicity, Customized
Non-Native American
|
18 Participants
n=213 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
22 Participants
n=218 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
0 Participants
n=64 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
2 Participants
n=67 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
42 Participants
n=562 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
|
Race/Ethnicity, Customized
Unknown/Missing
|
2 Participants
n=213 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
2 Participants
n=218 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
0 Participants
n=64 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
0 Participants
n=67 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
4 Participants
n=562 Participants • Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table.
|
|
Education
High school graduate, GED, or less
|
66 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
78 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
144 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Education
Some post-secondary
|
66 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
57 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
123 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Marital status
Unknown/Missing
|
7 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
4 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
11 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Education
-year, 4-year degree, or postgraduate
|
75 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
81 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
156 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Education
Unknown/Missing
|
6 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
2 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
8 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Marital status
Married
|
98 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
92 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
190 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Marital status
Not married
|
59 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
79 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
138 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Marital status
Divorced, separated, or widowed
|
49 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
43 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
92 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Household income
Less than $39,999
|
95 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
109 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
204 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Household income
$40,000 to $99,999
|
83 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
75 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
158 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Household income
$100,000 or more
|
20 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
24 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
44 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Household income
Unknown/Missing
|
15 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
10 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
25 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Employment status
Employed
|
130 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
144 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
274 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Employment status
Unemployed
|
12 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
11 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
23 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Employment status
Retired, unable to work, or other
|
65 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
58 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
123 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Employment status
Unknown/Missing
|
6 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
5 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
11 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Food security
High food security
|
67 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
70 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
137 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Food security
Marginal food security
|
48 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
50 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
98 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Food security
Low food security
|
65 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
55 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
120 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Food security
Very low food security
|
29 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
42 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
71 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Alcohol use
No
|
91 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
88 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
179 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Diabetes
Yes
|
57 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
35 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
92 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Food security
Unknown/Missing
|
4 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
1 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
5 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Smoking
Yes
|
45 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
41 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
86 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Smoking
No
|
168 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
177 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
345 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Alcohol use
Yes
|
122 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
130 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
252 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Diabetes
No
|
156 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
183 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
339 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Prediabetes
Yes
|
73 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
57 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
130 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Prediabetes
No
|
140 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
161 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
301 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Depression
Yes
|
68 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
78 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
146 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Depression
No
|
145 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
140 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
285 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Anxiety
Yes
|
93 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
97 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
190 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Anxiety
No
|
120 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
121 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
241 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Hypertension
Yes
|
114 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
110 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
224 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Hypertension
No
|
99 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
108 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
207 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Cardiovascular disease
Yes
|
8 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
14 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
22 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Cardiovascular disease
No
|
205 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
204 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
409 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Health status
Excellent
|
7 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
7 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
14 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Physical activity
None
|
20 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
23 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
43 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Health status
Very good
|
38 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
32 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
70 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Health status
Good
|
87 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
91 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
178 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Health status
Fair
|
67 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
71 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
138 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Health status
Poor
|
11 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
17 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
28 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Health status
Unknown/Missing
|
3 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
3 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Physical activity
Stretching
|
8 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
13 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
21 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Physical activity
Walk for exercise
|
112 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
119 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
231 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Physical activity
Swimming
|
10 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
13 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
23 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Physical activity
Bicycling
|
7 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
7 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
14 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Physical activity
Other aerobic exercise
|
53 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
40 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
93 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
|
Physical activity
Unknown/Missing
|
3 Participants
n=213 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
3 Participants
n=218 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
0 Participants
Analyzed for adults only. Baseline data not collected from Children Participants.
|
6 Participants
n=431 Participants • Analyzed for adults only. Baseline data not collected from Children Participants.
|
PRIMARY outcome
Timeframe: Baseline to 16-week follow-upPopulation: 31 participants were lost to follow-up from baseline
Measued on adults only. Change in vegetable and fruit intake using the National Cancer Instititute's Automated Self-Administered 24-hour Recall (ASA-24). This self-report instrument generates a "healthy eating index" (HEI), with scores ranging from 0 (least healthy) to 100 (healthiest). Continuous values of the overall HEI scores are reported.
Outcome measures
| Measure |
Intervention - Adult
n=192 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=208 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
Children of individuals that received the "Go Healthy" program
|
Control - Children
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in Diet From Baseline
|
4.1 Score
Standard Error 1.1
|
0.4 Score
Standard Error 1.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 16-week follow-upPopulation: 31 participants were lost to follow-up from baseline
Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.
Outcome measures
| Measure |
Intervention - Adult
n=192 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=208 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
Children of individuals that received the "Go Healthy" program
|
Control - Children
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline
|
-1.3 mmHg
Standard Error 1.2
|
-2.9 mmHg
Standard Error 1.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 16-week follow-upPopulation: 31 participants were lost to follow-up from baseline
Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.
Outcome measures
| Measure |
Intervention - Adult
n=192 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=208 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
Children of individuals that received the "Go Healthy" program
|
Control - Children
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline
|
-0.4 mmHg
Standard Error 0.7
|
-2.5 mmHg
Standard Error 0.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 16-week follow-upPopulation: 31 participants were lost to follow-up from baseline
Measured on adults only. Used a non-fasting blood sample device
Outcome measures
| Measure |
Intervention - Adult
n=192 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=208 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
Children of individuals that received the "Go Healthy" program
|
Control - Children
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in LDL-C From Baseline
|
-0.7 mg/dL
Standard Error 2.7
|
5.3 mg/dL
Standard Error 2.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 16-week follow-upPopulation: 31 adults and 37 children were lost to follow-up after the baseline visit
BMI (kg/m2) was calculated using measuredvheight and weight
Outcome measures
| Measure |
Intervention - Adult
n=192 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=208 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
n=43 Participants
Children of individuals that received the "Go Healthy" program
|
Control - Children
n=51 Participants
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in BMI From Baseline
|
-0.01 kg/m^2
Standard Error 0.2
|
0.3 kg/m^2
Standard Error 0.2
|
0.6 kg/m^2
Standard Error 0.3
|
0.6 kg/m^2
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and 16-week follow-upPopulation: 31 participants were lost to follow-up from baseline
Measured on adults only. Used a non-fasting blood sample device
Outcome measures
| Measure |
Intervention - Adult
n=192 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=208 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
Children of individuals that received the "Go Healthy" program
|
Control - Children
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline
|
-0.35 Percent
Standard Error 0.1
|
0.02 Percent
Standard Error 0.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 16-week follow-upPopulation: 31 participants were lost to follow-up from baseline
Assessed on adults only. Scale: U.S. Household Food Security Survey Module. This instrument contains 18 items to capture the qualitative and quantitative dimensions of household food supply. To compute levels of food security and insecurity, we will total the number of affirmative responses to these items, counting "Often" and "Sometimes" as affirmative. Total score range: 0-18. The lower scores, the greater improvement in food security.
Outcome measures
| Measure |
Intervention - Adult
n=192 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=208 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
Children of individuals that received the "Go Healthy" program
|
Control - Children
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in Food Insecurity From Baseline
|
-0.84 Score on a scale
Standard Error 0.2
|
-0.98 Score on a scale
Standard Error 0.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 16-week follow-upPopulation: 31 adults and 37 children were lost to follow-up.
Skin carotenoids were quantified using the Veggie Meter. Score range: 0 to 800. The higher the score, the higher vegetable intake.
Outcome measures
| Measure |
Intervention - Adult
n=192 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=208 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
n=43 Participants
Children of individuals that received the "Go Healthy" program
|
Control - Children
n=51 Participants
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in Skin Carotenoids From Baseline
|
-18.0 Score on a scale
Standard Error 4.9
|
-10.5 Score on a scale
Standard Error 4.5
|
-34.2 Score on a scale
Standard Error 11.5
|
-15.5 Score on a scale
Standard Error 8.8
|
SECONDARY outcome
Timeframe: Baseline to 16-week follow-upPopulation: 4 intervention participants and 1 control participant were missing data.
Health status was measured using one question from the 36-Item Short Form Health Survey questionnaire "In general, how would you rate your health status?" With response options of Excellent, Very Good, Good, Fair, and Poor. This outcome assesses proportion difference between baseline and follow-up of excellent/very good.
Outcome measures
| Measure |
Intervention - Adult
n=188 Participants
Individuals that received the "Go Healthy" program
|
Control - Adult
n=204 Participants
Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
Intervention - Children
Children of individuals that received the "Go Healthy" program
|
Control - Children
Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over
|
|---|---|---|---|---|
|
Change in Health Status From Baseline to Follow-up
|
-0.013 Proportion
|
-0.007 Proportion
|
—
|
—
|
Adverse Events
Intervention Group - Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control Group - Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Intervention Group - Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control Group - Children
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
Kaylee Clyma
Oklahoma State University Center for Health Sciences
Phone: 918-561-1581
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place