- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320331
Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project
The purpose of the OHA PILI 'Ohana Project is to disseminate and evaluate the effectiveness of a community-based intervention (PILI 'Ohana Intervention Program) aimed at eliminating obesity in Pacific Peoples across the four islands. Dissemination will involve implementation of the program in eight communities through partnerships with nine different community-based organizations serving those areas (four founding community partners and five new community partners). These organizations provide services to a large number of Pacific Peoples, including (but not limited to) Native Hawaiians, Samoans, Filipinos, and Chuukese.
The main aims are to: (1) train five additional community organizations and their staff to deliver the PILI 'Ohana Intervention Program, (2) to enroll 150 overweight/obese participants across 8 different communities and four different islands into the intervention program, and (3) to evaluate the effectiveness of the program in reducing weight/BMI by at least 3% of the participant's initial weight.
The PILI 'Ohana Intervention is a 9-month lifestyle intervention focusing on individual health behaviors in the context of family and community environments and in the socio-cultural context of Pacific Peoples. In order to increase the likelihood that an organization will implement the PLP, they will be able to adapt the intervention and participant assessments. The POP will provide guidance on adaption of the intervention and assessments at the training (CHS #21680). What is described below is the maximum amount of contact and assessment procedures that participants will undergo. Therefore, organizations may change the timing of the 14 lessons and refrain from using all the assessment procedures, but will still provide the 14 lessons and offer the same incentives to participants for assessments.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hawaii
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Honolulu, Hawaii, United States, 96813
- Department of Native Hawaiian Health, University of Hawaii
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI greater than or equal to 25
- Clients and/or residents of communities served by 9 partnering community organizations
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PILI Lifestyle Program
|
A 12-week Individual-focused Behavioral Weight Loss Intervention.
Our 12-week intervention is modeled after the Diabetes Prevention Program's (DPP) Lifestyle Intervention.
Each of the 8 lessons of this 12-week intervention will be done in a group classroom setting via trained community peer educators for a total of 8 group meetings as outlined above.
Lesson 1 through 4 will be done every week, once a week, for 4 weeks followed by every other week for the remaining 4 lessons (lessons 5 through 8).
Each group meeting will have between 12 to 15 people and take 1 to 1 ½ hours to complete.
After completing the 12-week behavioral weight loss intervention, participants will participate in an additional 6 lessons.
A lesson will be done once-a-month.
These 6 lessons will teach participants how to involve their family and friends in their healthy lifestyle changes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss
Time Frame: 9 months
|
Weight at 9 months compared to baseline
|
9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MD001660
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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