N/A
N=102
Healthy Body Healthy Souls in the Marshallese Population
Weight Loss · Pre Diabetes · Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03377244 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Mean Percent Body Weight (Pounds) Change — 0.88; 0.53; -1.06 percent weight change — p=0.1013
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HBHS (Behavioral); HBHS Policy (Behavioral); WORD DPP (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Body Weight (Pounds) Change |
0.88; 0.53; -1.06 | 0.1013 |
| SECONDARY Change in Mean HbA1c (%) |
0.12; -0.30; 0.16 | 0.4950 |
| SECONDARY Change in Mean Systolic Blood Pressure (mmHg) |
-7.23; -10.71; -13.62 | 0.7416 |
| SECONDARY Change in Mean Diastolic Blood Pressure (mmHg) |
2.69; 0.43; -5.18 | 0.0702 |
| SECONDARY Change in Eating Habits Self-Efficacy |
-0.15; -1.29; 1.76 | 0.0070 sig |
| SECONDARY Change in Physical Activity Self-Efficacy |
-0.44; -0.38; 0.28 | 0.0009 sig |
| SECONDARY Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month |
12; 10; 41; 9; 5; 38 | 0.3740 |
| SECONDARY Change in Sugar-Sweetened Beverage Consumption |
-0.71; -0.74; -0.73 | 0.9556 |
| SECONDARY Change in Fruit and Vegetable Consumption |
-0.38; 0.71; -0.47 | 0.1726 |
| SECONDARY Change in Perceived Family Support for Exercise and Dietary Habits |
-0.06; 0.25; 0.48 | 0.0478 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Self-reported Marshallese
- 18 years of age or older
- To participate in the DPP-LI, have a body mass index (BMI) of ≥25 kg/m^2
Exclusion Criteria
- A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.)
- Currently pregnant or breastfeeding an infant who is 6 months old or younger.
- 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.
Data sourced from ClinicalTrials.gov (NCT03377244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.