Trial Outcomes & Findings for Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population (NCT NCT03270436)
NCT ID: NCT03270436
Last Updated: 2020-12-09
Results Overview
Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
380 participants
Primary outcome timeframe
Baseline, immediate post-intervention, 6 months post-intervention
Results posted on
2020-12-09
Participant Flow
Participant milestones
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Baseline
STARTED
|
213
|
167
|
|
Baseline
COMPLETED
|
212
|
166
|
|
Baseline
NOT COMPLETED
|
1
|
1
|
|
Immediate Post-Intervention
STARTED
|
213
|
167
|
|
Immediate Post-Intervention
COMPLETED
|
172
|
111
|
|
Immediate Post-Intervention
NOT COMPLETED
|
41
|
56
|
|
6 Months Post-Intervention
STARTED
|
213
|
167
|
|
6 Months Post-Intervention
COMPLETED
|
173
|
116
|
|
6 Months Post-Intervention
NOT COMPLETED
|
40
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
Baseline characteristics by cohort
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
164 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
|
212 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
378 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
|
212 participants
n=5 Participants
|
166 participants
n=7 Participants
|
378 participants
n=5 Participants
|
|
Weight (kg)
|
85.4 kg
STANDARD_DEVIATION 15.6 • n=5 Participants
|
83.4 kg
STANDARD_DEVIATION 14.3 • n=7 Participants
|
84.4 kg
STANDARD_DEVIATION 15.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediate post-intervention, 6 months post-interventionChange in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.
Outcome measures
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Mean Body Weight (kg)
Baseline
|
86.44 Kilograms
Standard Error 1.65
|
84.32 Kilograms
Standard Error 1.80
|
|
Change in Mean Body Weight (kg)
Immediate post-intervention
|
86.47 Kilograms
Standard Error 1.72
|
84.40 Kilograms
Standard Error 1.97
|
|
Change in Mean Body Weight (kg)
6 months post-intervention
|
86.18 Kilograms
Standard Error 1.84
|
83.80 Kilograms
Standard Error 2.10
|
SECONDARY outcome
Timeframe: Baseline, immediate post-intervention, 6 months post-interventionChange in mean HbA1c (NGSP %) from baseline to immediate post-intervention and 6 months post-intervention. A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant at each time point.
Outcome measures
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Mean HbA1c (%)
Baseline
|
7.27 Percent Glycated Hemoglobin
Standard Error 0.30
|
7.66 Percent Glycated Hemoglobin
Standard Error 0.33
|
|
Change in Mean HbA1c (%)
Immediate post-intervention
|
7.32 Percent Glycated Hemoglobin
Standard Error 0.31
|
7.55 Percent Glycated Hemoglobin
Standard Error 0.36
|
|
Change in Mean HbA1c (%)
6 months post-intervention
|
7.25 Percent Glycated Hemoglobin
Standard Error 0.33
|
7.61 Percent Glycated Hemoglobin
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline, immediate post-intervention, 6 months post-interventionChange in mean systolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.
Outcome measures
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Mean Systolic Blood Pressure (mmHg)
Baseline
|
129.42 mmHg
Standard Error 2.39
|
128.20 mmHg
Standard Error 2.60
|
|
Change in Mean Systolic Blood Pressure (mmHg)
Immediate post-intervention
|
126.83 mmHg
Standard Error 2.47
|
119.65 mmHg
Standard Error 2.82
|
|
Change in Mean Systolic Blood Pressure (mmHg)
6 months post-intervention
|
120.75 mmHg
Standard Error 2.61
|
118.30 mmHg
Standard Error 2.96
|
SECONDARY outcome
Timeframe: Baseline, immediate post-intervention, 6 months post-interventionChange in mean diastolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.
Outcome measures
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Mean Diastolic Blood Pressure (mmHg)
6 months post-intervention
|
76.41 mmHg
Standard Error 1.29
|
76.24 mmHg
Standard Error 1.49
|
|
Change in Mean Diastolic Blood Pressure (mmHg)
Baseline
|
79.60 mmHg
Standard Error 1.12
|
78.33 mmHg
Standard Error 1.22
|
|
Change in Mean Diastolic Blood Pressure (mmHg)
Immediate post-intervention
|
78.50 mmHg
Standard Error 1.19
|
74.08 mmHg
Standard Error 1.38
|
SECONDARY outcome
Timeframe: Baseline, immediate post-intervention, 6 months post-interventionChange in participants' sugar-sweetened beverage (SSB) consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' SSB consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the Center for Disease Control and Prevention'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 |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Sugar-sweetened Beverage Consumption
Baseline
|
1.65 SSBs consumed per day
Standard Error 0.16
|
2.16 SSBs consumed per day
Standard Error 0.17
|
|
Change in Sugar-sweetened Beverage Consumption
Immediate post-intervention
|
1.24 SSBs consumed per day
Standard Error 0.17
|
1.36 SSBs consumed per day
Standard Error 0.20
|
|
Change in Sugar-sweetened Beverage Consumption
6 months post-intervention
|
1.18 SSBs consumed per day
Standard Error 0.17
|
1.40 SSBs consumed per day
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, immediate post-intervention, 6 months post-interventionChange in participants' fruit and vegetable consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three items adapted from: Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997;6(5):355-361. 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 fruits and vegetables.
Outcome measures
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Fruit and Vegetable Consumption
Baseline
|
3.59 scale score
Standard Error 0.15
|
3.70 scale score
Standard Error 0.16
|
|
Change in Fruit and Vegetable Consumption
Immediate post-intervention
|
3.94 scale score
Standard Error 0.16
|
3.72 scale score
Standard Error 0.18
|
|
Change in Fruit and Vegetable Consumption
6 months post-intervention
|
4.10 scale score
Standard Error 0.16
|
3.80 scale score
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, immediate post-intervention, 6 months post-interventionPopulation: Analysis includes only those with data on the relevant outcome.
Change in proportion of participants engaging in sufficient levels of physical activity (PA) from baseline to immediate post-intervention and 6 months post-intervention. This measure assessed participants' frequency of engaging in both moderate and vigorous PA over the past month (\>4 times a week, 2-4 times a week, about once a week, etc.). This measure was adapted to include relevant cultural examples of PA from the Dietary Approaches to Stop Hypertension 2 Brief Physical Activity Questionnaire (https://biolincc.nhlbi.nih.gov/media/studies/dashsodium/Forms\_Manual.pdf?link\_time=2018-11-13\_18:06:05.776099). 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.
Outcome measures
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity
Immediate post-intervention
|
108 Participants
|
63 Participants
|
|
Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity
Baseline
|
112 Participants
|
78 Participants
|
|
Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity
6 months post-intervention
|
99 Participants
|
65 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Immediate post-intervention, 6 months post-interventionChange in eating habits self-efficacy from baseline to immediate post-intervention and 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 television, etc.). This 7-item measure was adapted from items in the original Weight Efficacy Life-Style (WEL) Questionnaire (Clark MM, Abrams DB, Niaura RS, et al. Self-efficacy in weight management. J Consult Clin Psychol. 1991;59(5):739-744). 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 |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Eating Habits Self-efficacy Score
Immediate post-intervention
|
11.77 scale score
Standard Error 0.28
|
11.92 scale score
Standard Error 0.33
|
|
Change in Eating Habits Self-efficacy Score
6 months post-intervention
|
11.87 scale score
Standard Error 0.28
|
11.62 scale score
Standard Error 0.32
|
|
Change in Eating Habits Self-efficacy Score
Baseline
|
10.97 scale score
Standard Error 0.26
|
11.46 scale score
Standard Error 0.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Immediate post-intervention, 6 months post-interventionChange in physical activity self-efficacy from baseline to immediate post-intervention and 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 (SEE) Scale (Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000;49(3):154-159. \& Resnick B, Luisi D, Vogel A, Junaleepa P. Reliability and validity of the Self-Efficacy for Exercise and Outcome Expectations for Exercise Scales with minority older adults. J Nurs Measurement. 2004; 12(3):235-247.) 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.
Outcome measures
| Measure |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Physical Activity Self-efficacy
Baseline
|
13.64 scale score
Standard Error 0.41
|
14.24 scale score
Standard Error 0.45
|
|
Change in Physical Activity Self-efficacy
Immediate post-intervention
|
13.87 scale score
Standard Error 0.44
|
14.72 scale score
Standard Error 0.51
|
|
Change in Physical Activity Self-efficacy
6 months post-intervention
|
14.34 scale score
Standard Error 0.44
|
13.57 scale score
Standard Error 0.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Immediate post-intervention, 6 months post-interventionChange in perceived family support for exercise and dietary habits from baseline to immediate post-intervention and 6 months post-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 KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008;43(171):557-575. 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 |
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
n=212 Participants
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (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 includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.
|
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
n=166 Participants
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
|
|---|---|---|
|
Change in Perceived Family Support for Exercise and Dietary Habits
Baseline
|
4.99 scale score
Standard Error 0.25
|
5.50 scale score
Standard Error 0.27
|
|
Change in Perceived Family Support for Exercise and Dietary Habits
Immediate post-intervention
|
6.66 scale score
Standard Error 0.27
|
6.38 scale score
Standard Error 0.31
|
|
Change in Perceived Family Support for Exercise and Dietary Habits
6 months post-intervention
|
6.48 scale score
Standard Error 0.27
|
6.46 scale score
Standard Error 0.31
|
Adverse Events
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
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