NCT03377244

Healthy Body Healthy Souls in the Marshallese Population

Completed NA Results posted Last updated 29 January 2021

What this trial tests

NA trial testing HBHS in Weight Loss in 102 participants. Completed in 31 October 2019.

Timeline

30 September 2018

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	University of Arkansas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	102
Start date	30 September 2018
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	1 location across United States

Drugs / interventions tested

• HBHS
• HBHS Policy
• WORD DPP

Conditions studied

• Weight Loss — all drugs for Weight Loss →
• Pre Diabetes — all drugs for Pre Diabetes →
• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

University of Arkansas

Who can join

18 and older, any sex, with Weight Loss or Pre Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Percent Body Weight (Pounds) Change Primary · Baseline, 6 months post-intervention

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.

Group	Value	95% CI
HBHS	0.88	± 3.99
HBHS Policy	0.53	± 3.81
WORD DPP	-1.06	± 4.37

Change in Mean HbA1c (%) Secondary · Baseline, 6 months post-intervention

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.

Group	Value	95% CI
HBHS	0.12	± 1.19
HBHS Policy	-0.30	± 1.19
WORD DPP	0.16	± 1.01

Change in Mean Systolic Blood Pressure (mmHg) Secondary · Baseline, 6 months post-intervention

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.

Group	Value	95% CI
HBHS	-7.23	± 12.31
HBHS Policy	-10.71	± 10.72
WORD DPP	-13.62	± 22.5

Change in Mean Diastolic Blood Pressure (mmHg) Secondary · Baseline, 6 months post-intervention

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.

Group	Value	95% CI
HBHS	2.69	± 11.69
HBHS Policy	0.43	± 9.50
WORD DPP	-5.18	± 15.67

Change in Eating Habits Self-Efficacy Secondary · Baseline, 6 months post-intervention

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/Com

Group	Value	95% CI
HBHS	-0.15	± 2.51
HBHS Policy	-1.29	± 3.15
WORD DPP	1.76	± 2.88

Change in Physical Activity Self-Efficacy Secondary · Baseline, 6 months post-intervention

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 "N

Group	Value	95% CI
HBHS	-0.44	± 0.76
HBHS Policy	-0.38	± 0.61
WORD DPP	0.28	± 0.58

Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month Secondary · Baseline, 6 months post-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;

Baseline

Group	Value	95% CI
HBHS	12
HBHS Policy	10
WORD DPP	41

6 months post-intervention

Group	Value	95% CI
HBHS	9
HBHS Policy	5
WORD DPP	38

Change in Sugar-Sweetened Beverage Consumption Secondary · Baseline, 6 months post-intervention

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-repo

Group	Value	95% CI
HBHS	-0.71	± 2.07
HBHS Policy	-0.74	± 1.52
WORD DPP	-0.73	± 1.97

Change in Fruit and Vegetable Consumption Secondary · Baseline, 6 months post-intervention

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

Group	Value	95% CI
HBHS	-0.38	± 0.77
HBHS Policy	0.71	± 2.14
WORD DPP	-0.47	± 2.03

Change in Perceived Family Support for Exercise and Dietary Habits Secondary · Baseline, 6 months post-intervention

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

Group	Value	95% CI
HBHS	-0.06	± 0.45
HBHS Policy	0.25	± 0.94
WORD DPP	0.48	± 0.66

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.