Trial Outcomes & Findings for Healthy Body Healthy Souls in the Marshallese Population (NCT NCT03377244)
NCT ID: NCT03377244
Last Updated: 2021-01-29
Results Overview
Mean percent body weight (pounds) change from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb using a calibrated digital scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Baseline, 6 months post-intervention
Results posted on
2021-01-29
Participant Flow
Participant milestones
| Measure |
HBHS
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Baseline
STARTED
|
19
|
14
|
69
|
|
Baseline
COMPLETED
|
19
|
14
|
69
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
|
6 Months Post-intervention
STARTED
|
19
|
14
|
69
|
|
6 Months Post-intervention
COMPLETED
|
13
|
7
|
55
|
|
6 Months Post-intervention
NOT COMPLETED
|
6
|
7
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy Body Healthy Souls in the Marshallese Population
Baseline characteristics by cohort
| Measure |
HBHS
n=19 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=14 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=69 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
14 participants
n=7 Participants
|
69 participants
n=5 Participants
|
102 participants
n=4 Participants
|
|
Weight (lb)
|
191.5 pounds
STANDARD_DEVIATION 45.2 • n=5 Participants
|
171.6 pounds
STANDARD_DEVIATION 36.4 • n=7 Participants
|
184.1 pounds
STANDARD_DEVIATION 31.6 • n=5 Participants
|
183.8 pounds
STANDARD_DEVIATION 35.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Mean percent body weight (pounds) change from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb using a calibrated digital scale.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=7 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Mean Percent Body Weight (Pounds) Change
|
0.88 percent weight change
Standard Deviation 3.99
|
0.53 percent weight change
Standard Deviation 3.81
|
-1.06 percent weight change
Standard Deviation 4.37
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Change in mean HbA1c (NGSP %) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=7 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Change in Mean HbA1c (%)
|
0.12 Percent Glycated Hemoglobin
Standard Deviation 1.19
|
-0.30 Percent Glycated Hemoglobin
Standard Deviation 1.19
|
0.16 Percent Glycated Hemoglobin
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Change in mean systolic blood pressure (mmHg) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Blood pressure was measured with a sphygmomanometer, with participants seated.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=7 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Change in Mean Systolic Blood Pressure (mmHg)
|
-7.23 mmHg
Standard Deviation 12.31
|
-10.71 mmHg
Standard Deviation 10.72
|
-13.62 mmHg
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Change in mean diastolic blood pressure (mmHg) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Blood pressure was measured with a sphygmomanometer, with participants seated.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=7 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Change in Mean Diastolic Blood Pressure (mmHg)
|
2.69 mmHg
Standard Deviation 11.69
|
0.43 mmHg
Standard Deviation 9.50
|
-5.18 mmHg
Standard Deviation 15.67
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Change in eating habits self-efficacy from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy related to their ability to make healthy eating decisions in the face of real or perceived barriers (e.g. while at social events, while watching TV, etc.). This 7-item measure was adapted from items in the original Weight Efficacy Life-Style Questionnaire by Clark et al (1991) (reference provided in the References in the Protocol Section). Each of the 7 items are measured via 3 response options ("Yes/Completely Sure"=2; "Maybe/Not Sure"=1; and "No/Not Sure at All"=0), giving a possible range of scores of 0-14, with higher scores indicating higher self-efficacy for making healthy eating decisions in spite of barriers.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=7 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Change in Eating Habits Self-Efficacy
|
-0.15 scores on a scale
Standard Deviation 2.51
|
-1.29 scores on a scale
Standard Deviation 3.15
|
1.76 scores on a scale
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Change in physical activity self-efficacy from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy for exercising in the face of real or perceived barriers (e.g., bad weather, exercising alone, etc.). This 9-item measure was adapted from the Self-Efficacy for Exercise Scale by Resnick \& Jenkins (2000) and Resnick et al (2004) (references provided in the References in the Protocol Section). Each of the 9 items are measured via 3 response options ("Yes/Completely Sure"=2; "Maybe/Not Sure"=1; and "No/Not Sure at All"=0), giving a possible range of scores of 0-18, with higher scores indicating higher self-efficacy for exercising despite barriers.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=7 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Change in Physical Activity Self-Efficacy
|
-0.44 scores on a scale
Standard Deviation 0.76
|
-0.38 scores on a scale
Standard Deviation 0.61
|
0.28 scores on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Number of participants engaging in sufficient physical activity at baseline and 6 months post-intervention (12 months post-initiation of the intervention).
Change in percentage of participants engaging in sufficient levels of physical activity (PA) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' frequency of engaging in both moderate and vigorous levels of physical activity over the past month with two items. Both items used a 4-point response scale: 1) Rarely or Never; 2) Once a week; 3) 2-4 times a week; and 4) More than 4 times a week. Each 4-point scale for moderate PA and vigorous PA was weighted: 0=Rarely or Never; 1=Once a week; 2=2-4 times a week; and 4=More than 4 times a week. The weights were then summed and dichotomized as follows: ≥4 = sufficient PA and \<4 = insufficient PA. Items were adapted to include relevant cultural examples of physical activity from the DASH 2 Brief Physical Activity Questionnaire (link to original items provided in the References in the Protocol Section).
Outcome measures
| Measure |
HBHS
n=19 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=14 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=69 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month
Baseline
|
12 Participants
|
10 Participants
|
41 Participants
|
|
Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month
6 months post-intervention
|
9 Participants
|
5 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Change in participants' sugar-sweetened beverage consumption from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' sugar-sweetened beverage consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the CDC's Behavioral Risk Factor Surveillance System (BRFSS). Participants could respond in number of times per day, per week, or per month. Responses for each question were converted to number of times per day (i.e., self-reported times per week divided by 7 or self-reported times per month divided by 30), resulting in two measures: number times soda was consumed per day and number of times sugar-sweetened fruit drinks, sweet tea, and sports drinks were consumed per day. Per BRFSS guidelines, these two measures were added together to create a total daily SSB consumption rate.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=6 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Change in Sugar-Sweetened Beverage Consumption
|
-0.71 SSBs consumed per day
Standard Deviation 2.07
|
-0.74 SSBs consumed per day
Standard Deviation 1.52
|
-0.73 SSBs consumed per day
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Change in participants' fruit and vegetable consumption from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three questions adapted from: Shannon et al (1997) (reference provided in the References in the Protocol Section). Each of the three items was scored as Often=2; Sometimes=1; Never=0. Items were summed to create a scale score, giving a possible range of scores of 0-6, with higher scores indicating more frequent consumption of fruit and vegetables.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=7 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
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Change in Fruit and Vegetable Consumption
|
-0.38 scores on a scale
Standard Deviation 0.77
|
0.71 scores on a scale
Standard Deviation 2.14
|
-0.47 scores on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-interventionPopulation: Only those with available baseline and follow-up data were analyzed.
Change in perceived family support for exercise and dietary habits from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure was adapted to examine changes in perceived family support for engaging in healthy exercise and dietary habits. This measure consists of a 6-item scale adapted from: Gruber (2008) (reference provided in the References in the Protocol Section). Each of the 6 items are measured via 3 response options ("Often"=2; "Sometimes"=1; and "Never"=0), giving a possible range of scores of 0-12, with higher scores indicating higher perceived family support for exercising and eating healthier.
Outcome measures
| Measure |
HBHS
n=13 Participants
Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
|
HBHS Policy
n=7 Participants
Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.
HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors.
|
WORD DPP
n=55 Participants
Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
|---|---|---|---|
|
Change in Perceived Family Support for Exercise and Dietary Habits
|
-0.06 scores on a scale
Standard Deviation 0.45
|
0.25 scores on a scale
Standard Deviation 0.94
|
0.48 scores on a scale
Standard Deviation 0.66
|
Adverse Events
HBHS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HBHS Policy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WORD DPP
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
Dr. Pearl A. McElfish
University of Arkansas for Medical Sciences
Phone: 479-713-8680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place