N/A
Completed N=380
Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
Source: ClinicalTrials.gov NCT03270436 ↗Enrolled (actual)
380
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Change in Mean Body Weight (kg) — 86.44; 84.32; 86.47; 84.40 Kilograms — p=0.3599
Summary
The investigators will conduct a comparative effectiveness cluster-randomized controlled trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based intervention (Wholeness, Oneness, Righteousness, Deliverance [WORD] DPP); and a Pacific Islander adapted intervention (Partnership for Improving Lifestyle Interventions [PILI] DPP. Each intervention lasted 24 weeks and focused on the importance of healthy eating, being physically active, and maintaining a healthy weight. Eligible participants included overweight and obese Marshallese adults living in Arkansas and Oklahoma. The unit of randomization is at the church level. The primary outcome measure is body weight loss (from baseline weight). As selected by stakeholders, HbA1c, blood pressure, physical activity, and dietary intake will be evaluated as secondary outcome measures. Data collection will take place at baseline (pre-intervention), immediate post-intervention (6 months post-initiation of the intervention), and 6 months post-intervention (12 months post-initiation of the intervention).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Body Weight (kg) |
86.44; 84.32; 86.47; 84.40; 86.18; 83.80 | 0.3599 |
| SECONDARY Change in Mean HbA1c (%) |
7.27; 7.66; 7.32; 7.55; 7.25; 7.61 | 0.5698 |
| SECONDARY Change in Mean Systolic Blood Pressure (mmHg) |
129.42; 128.20; 126.83; 119.65; 120.75; 118.30 | 0.0293 sig |
| SECONDARY Change in Mean Diastolic Blood Pressure (mmHg) |
79.60; 78.33; 78.50; 74.08; 76.41; 76.24 | 0.0068 sig |
| SECONDARY Change in Sugar-sweetened Beverage Consumption |
1.65; 2.16; 1.24; 1.36; 1.18; 1.40 | 0.5984 |
| SECONDARY Change in Fruit and Vegetable Consumption |
3.59; 3.70; 3.94; 3.72; 4.10; 3.80 | 0.2960 |
| SECONDARY Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity |
112; 78; 108; 63; 99; 65 | 0.2824 |
Eligibility Criteria
Inclusion Criteria
- Self reported Marshallese
- 18 years of age or older
- BMI greater than or equal to 25
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, an inability to finish the intervention, etc.
Data sourced from ClinicalTrials.gov (NCT03270436). 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. Informational only — not medical advice.