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Healthy Body Healthy Souls in the Marshallese Population

Healthy Body Healthy Souls: A Weight Loss Intervention Using Diabetes Prevention Program Lifestyle Intervention (DPP-LI) With Church Level Systems Change in the Marshallese Population

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03377244
Enrollment
102
Registered
2017-12-19
Start date
2018-09-30
Completion date
2019-10-31
Last updated
2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Pre Diabetes, Weight Loss

Keywords

Marshallese, Pacific Islanders

Brief summary

The primary aim is to pilot test a weight-loss intervention for Marshallese adults, referred to throughout as Healthy Bodies Healthy Souls (HBHS). The HBHS intervention includes the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) implemented at the individual level, with the additional enhancement of working with Marshallese churches to implement church-level changes to support the individual behavioral intervention of the WORD DPP. We will then compare changes in outcomes with participants in the churches who were exposed to the policy changes but did not participate in the WORD DPP, and with those enrolled in a separate DPP trial who participated in the WORD DPP but were not exposed to church-level policy changes.

Detailed description

Background and Rationale Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific Islanders. This study focuses on the Marshallese living in Arkansas. The Marshallese are a Pacific Islander population experiencing significant health disparities, with some of the highest documented rates of type 2 diabetes of any population group in the world. Our review of local, national, and international data sources found estimates of diabetes in the Marshallese population (in the US and the Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8% for the US population and 4% worldwide. While national prevalence data are limited, 23.7% of Pacific Islanders surveyed by the Centers for Disease Control and Prevention (CDC) in 2010 reported a diagnosis of type 2 diabetes - more than all other racial/ethnic groups. Our preliminary research, which included health screenings with the Marshallese community in Northwest Arkansas (n = 401), documented extremely high incidence of diabetes (38.2%) and pre-diabetes (32.4%). Our pilot data also revealed similar disparities in obesity, one of the strongest risk factors for diabetes; 90% of Marshallese participants were classified as overweight or obese. Further compounding these significant disparities, Pacific Islanders living in the US are less likely than other racial/ethnic groups to receive preventive or diagnostic treatment or diabetes education. This study addresses an urgent need for interventions to reduce obesity and diabetes disparities in the Marshallese community and will employ a culturally appropriate, multilevel approach. The scientific premise of our study includes four main points. First, the Marshallese in Arkansas suffer from a significant and disproportionate burden of type 2 diabetes and lack access to effective prevention and treatment due to a dearth of research with Pacific Islanders.Second, the association between weight gain and risk for type 2 diabetes is strong. Overweight/obesity is considered the strongest modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) is clinically meaningful. Third, research demonstrates the effectiveness of multi-level lifestyle interventions in reducing weight and the onset and impact of diabetes. Fourth, to be effective among Pacific Islanders, interventions must be developed to address influences at multiple levels and should be culturally adapted to incorporate Pacific Islanders' worldviews and cultural values. Prior research indicates the importance of using a Community Based Participatory Research (CBPR) approach to understand and integrate cultural nuances during the cultural adaptation process and implementation of multilevel interventions. A CBPR approach is also essential to conducting ethical, valid health research in populations whose health beliefs and behaviors have been shaped by historical trauma. Finally, churches are primary social institutions of Pacific Islander health. Faith-based interventions are effective at improving behavioral and anthropometric outcomes within collectivistic communities and therefore hold great promise for Marshallese and other Pacific Islanders.

Interventions

BEHAVIORALHBHS

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.

BEHAVIORALHBHS Policy

Church-level policy changes that encourages participants to engage in healthy behaviors.

BEHAVIORALWORD DPP

Faith based diabetes curriculum that teaches participants to connect faith and health.

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Our aim is to pilot test a multi-level weight-loss intervention in the Marshallese community. Changes in outcomes were examined from baseline to 6 months post-intervention (12 months post-initiation of the intervention).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Self-reported Marshallese 2. 18 years of age or older 3. To participate in the DPP-LI, have a body mass index (BMI) of ≥25 kg/m\^2

Exclusion criteria

1. A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.) 2. Currently pregnant or breastfeeding an infant who is 6 months old or younger. 3. Have any condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, plans to move out of the area within 6 months, and inability to finish the intervention, etc.

Design outcomes

Primary

MeasureTime frameDescription
Mean Percent Body Weight (Pounds) ChangeBaseline, 6 months post-interventionMean 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.

Secondary

MeasureTime frameDescription
Change in Mean Systolic Blood Pressure (mmHg)Baseline, 6 months post-interventionChange 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.
Change in Mean Diastolic Blood Pressure (mmHg)Baseline, 6 months post-interventionChange 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.
Change in Eating Habits Self-EfficacyBaseline, 6 months post-interventionChange 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.
Change in Physical Activity Self-EfficacyBaseline, 6 months post-interventionChange 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.
Change in Mean HbA1c (%)Baseline, 6 months post-interventionChange 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.
Change in Sugar-Sweetened Beverage ConsumptionBaseline, 6 months post-interventionChange 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.
Change in Fruit and Vegetable ConsumptionBaseline, 6 months post-interventionChange 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.
Change in Perceived Family Support for Exercise and Dietary HabitsBaseline, 6 months post-interventionChange 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.
Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past MonthBaseline, 6 months post-interventionChange 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
19
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.
14
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.
69
Total102

Baseline characteristics

CharacteristicHBHS PolicyHBHSWORD DPPTotal
Age, Continuous27.3 years
STANDARD_DEVIATION 8.4
36.6 years
STANDARD_DEVIATION 9.8
43.7 years
STANDARD_DEVIATION 9.8
40.1 years
STANDARD_DEVIATION 11.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
14 Participants19 Participants69 Participants102 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
14 participants19 participants69 participants102 participants
Sex: Female, Male
Female
8 Participants11 Participants44 Participants63 Participants
Sex: Female, Male
Male
6 Participants8 Participants25 Participants39 Participants
Weight (lb)171.6 pounds
STANDARD_DEVIATION 36.4
191.5 pounds
STANDARD_DEVIATION 45.2
184.1 pounds
STANDARD_DEVIATION 31.6
183.8 pounds
STANDARD_DEVIATION 35.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 140 / 69
other
Total, other adverse events
0 / 190 / 140 / 69
serious
Total, serious adverse events
0 / 190 / 140 / 69

Outcome results

Primary

Mean Percent Body Weight (Pounds) Change

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSMean Percent Body Weight (Pounds) Change0.88 percent weight changeStandard Deviation 3.99
HBHS PolicyMean Percent Body Weight (Pounds) Change0.53 percent weight changeStandard Deviation 3.81
WORD DPPMean Percent Body Weight (Pounds) Change-1.06 percent weight changeStandard Deviation 4.37
p-value: 0.1013general linear model
Secondary

Change in Eating Habits Self-Efficacy

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSChange in Eating Habits Self-Efficacy-0.15 scores on a scaleStandard Deviation 2.51
HBHS PolicyChange in Eating Habits Self-Efficacy-1.29 scores on a scaleStandard Deviation 3.15
WORD DPPChange in Eating Habits Self-Efficacy1.76 scores on a scaleStandard Deviation 2.88
p-value: 0.007general linear model
Secondary

Change in Fruit and Vegetable Consumption

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSChange in Fruit and Vegetable Consumption-0.38 scores on a scaleStandard Deviation 0.77
HBHS PolicyChange in Fruit and Vegetable Consumption0.71 scores on a scaleStandard Deviation 2.14
WORD DPPChange in Fruit and Vegetable Consumption-0.47 scores on a scaleStandard Deviation 2.03
p-value: 0.1726general linear model
Secondary

Change in Mean Diastolic Blood Pressure (mmHg)

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSChange in Mean Diastolic Blood Pressure (mmHg)2.69 mmHgStandard Deviation 11.69
HBHS PolicyChange in Mean Diastolic Blood Pressure (mmHg)0.43 mmHgStandard Deviation 9.5
WORD DPPChange in Mean Diastolic Blood Pressure (mmHg)-5.18 mmHgStandard Deviation 15.67
p-value: 0.0702general linear model
Secondary

Change in Mean HbA1c (%)

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSChange in Mean HbA1c (%)0.12 Percent Glycated HemoglobinStandard Deviation 1.19
HBHS PolicyChange in Mean HbA1c (%)-0.30 Percent Glycated HemoglobinStandard Deviation 1.19
WORD DPPChange in Mean HbA1c (%)0.16 Percent Glycated HemoglobinStandard Deviation 1.01
p-value: 0.495general linear model
Secondary

Change in Mean Systolic Blood Pressure (mmHg)

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSChange in Mean Systolic Blood Pressure (mmHg)-7.23 mmHgStandard Deviation 12.31
HBHS PolicyChange in Mean Systolic Blood Pressure (mmHg)-10.71 mmHgStandard Deviation 10.72
WORD DPPChange in Mean Systolic Blood Pressure (mmHg)-13.62 mmHgStandard Deviation 22.5
p-value: 0.7416general linear model
Secondary

Change in Perceived Family Support for Exercise and Dietary Habits

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSChange in Perceived Family Support for Exercise and Dietary Habits-0.06 scores on a scaleStandard Deviation 0.45
HBHS PolicyChange in Perceived Family Support for Exercise and Dietary Habits0.25 scores on a scaleStandard Deviation 0.94
WORD DPPChange in Perceived Family Support for Exercise and Dietary Habits0.48 scores on a scaleStandard Deviation 0.66
p-value: 0.0478general linear model
Secondary

Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month

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).

Time frame: Baseline, 6 months post-intervention

Population: Number of participants engaging in sufficient physical activity at baseline and 6 months post-intervention (12 months post-initiation of the intervention).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HBHSChange in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past MonthBaseline12 Participants
HBHSChange in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month6 months post-intervention9 Participants
HBHS PolicyChange in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past MonthBaseline10 Participants
HBHS PolicyChange in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month6 months post-intervention5 Participants
WORD DPPChange in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past MonthBaseline41 Participants
WORD DPPChange in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month6 months post-intervention38 Participants
p-value: 0.374Regression, Logistic
Secondary

Change in Physical Activity Self-Efficacy

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSChange in Physical Activity Self-Efficacy-0.44 scores on a scaleStandard Deviation 0.76
HBHS PolicyChange in Physical Activity Self-Efficacy-0.38 scores on a scaleStandard Deviation 0.61
WORD DPPChange in Physical Activity Self-Efficacy0.28 scores on a scaleStandard Deviation 0.58
p-value: 0.0009general linear model
Secondary

Change in Sugar-Sweetened Beverage Consumption

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.

Time frame: Baseline, 6 months post-intervention

Population: Only those with available baseline and follow-up data were analyzed.

ArmMeasureValue (MEAN)Dispersion
HBHSChange in Sugar-Sweetened Beverage Consumption-0.71 SSBs consumed per dayStandard Deviation 2.07
HBHS PolicyChange in Sugar-Sweetened Beverage Consumption-0.74 SSBs consumed per dayStandard Deviation 1.52
WORD DPPChange in Sugar-Sweetened Beverage Consumption-0.73 SSBs consumed per dayStandard Deviation 1.97
p-value: 0.9556general linear model

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026