- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01093924
Partnerships to Overcome Obesity Disparities in Hawaii: 18-month CBPR Study
November 13, 2013 updated by: University of Hawaii
Partnerships to Overcome Obesity Disparities in Hawaii
This is a 5-year community-based participatory research intervention study with the goals of 1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and Pacific Peoples and 2) identifying the aspects of the community-academic partnership that fosters a co-learning and co-equal environment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Obesity and overweight are well recognized public health concerns in the US and the magnitude of excess weight is greater among racial/ethnic minority populations.
For NHs and PPs 70 to 80% of adults are estimated to be overweight or obese.
Obesity-related disparities such as diabetes and heart disease (CVD) are also increasing among NHs and PPs.
To address obesity and related disparities, a community-based participatory research (CBPR) partnership was formed entitled, the Partnership for Improving Lifestyle Interventions (PILI) 'Ohana Program (Pili meaning relationship and 'Ohana meaning family).
The PILI 'Ohana Program (POP) consists of 5 community organizations and the Department of Native Hawaiian Health (DNHH) at the John A. Burns School of Medicine (JABSOM) of the University of Hawai'i (UH).
With a 3-year CBPR planning grant from the National Center on Minority Health and Health Disparities (NCMHD), the POP was successful at establishing this community-academic partnership aimed at obesity-related disparities in Hawai'i and in implementing a pilot intervention to address weight loss maintenance (the PILI 'Ohana Intervention) in NHs and PPs, which serves as preliminary data for this application.
The specific aims are as follow: 1) To identify the aspects of the PILI 'Ohana (family + community focused) Intervention deemed effective by former participants and community-peer educators of the pilot intervention.
2) To test whether a face-to-face or DVD delivery method of the PILI 'Ohana intervention is effective in improving weight loss maintenance versus a control group in NHs and PPs. 3) To identify the strengths of the PILI 'Ohana Program that supports a co-learning and co-equal environment.
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
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Honolulu, Hawaii, United States, 96819
- Kokua Kalihi Valley
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Honolulu, Hawaii, United States, 96807
- Hawaii Maoli
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Honolulu, Hawaii, United States, 96813
- Ke Ola Mamo
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Honolulu, Hawaii, United States, 96816
- Kula no na Po'e Hawaii
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background;
- Age 18 years or older
- Overweight or Obese defined as BMI > 25 kg/m2 (NH or Pacific Islanders) or > 23 kg/m2 (Filipino ethnic background)
- Willing and able to follow a weight loss maintenance intervention program that could include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to maintain weight loss
- Able to identify at least one family, friend, or co-worker who would be willing to support the participant during the course of the study
Exclusion Criteria:
- Survival less than 6 months
- Planning to move out of the community during the intervention study period
- Pregnancy
- Any dietary or exercise restrictions that would prevent an individual from fully participating in the intervention protocol (i.e., end-stage renal disease on a renal diet, etc.)
- Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., severe arthritis, hemi-paresis, major psychiatric illness, eating disorders, etc.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: self-guided weight loss maintenance
15-month self-guided weight loss maintenance group will receive monthly reminders to maintain their weight loss and newsletters that contain health information.
|
|
Experimental: DVD group
15-month weight loss maintenance intervention deliver via DVD.
|
All participants will receive a 8 lesson 3-month weight loss intervention.
They will then be randomized.
Those continuing with the intervention will receive 17 more lessons delivered face-to-face or via DVD over 15 months for a total of 18 months.
Each lesson lasts approximately 1 hour and helps participants integrate healthy eating and physical activity into their lifestyles.
Participants will also be encouraged to attend 13 community activities during the last 13 months of the intervention.
Other Names:
|
Experimental: face-to-face group
15-month weight loss/weight loss maintenance intervention delivered in a group setting
|
All participants will receive a 8 lesson 3-month weight loss intervention.
They will then be randomized.
Those continuing with the intervention will receive 17 more lessons delivered face-to-face or via DVD over 15 months for a total of 18 months.
Each lesson lasts approximately 1 hour and helps participants integrate healthy eating and physical activity into their lifestyles.
Participants will also be encouraged to attend 13 community activities during the last 13 months of the intervention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss
Time Frame: 18-months
|
Amount of Weight loss in kilograms from baseline to 18 month follow-up
|
18-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic/diastolic blood pressure
Time Frame: 18-months
|
Systolic/diastolic blood pressure (mmHg) as measured by an electronic blood pressure device
|
18-months
|
Self-reported dietary fat intake
Time Frame: 18-months
|
Self-reported dietary fat intake using an 18-item Food Frequency Questionnaire
|
18-months
|
Self-reported physical activity
Time Frame: 18-months
|
Self-reported physical activity frequency and intensity using a 3-item brief physical activity questionnaire
|
18-months
|
Physical functioning
Time Frame: 18-month
|
Physical functioning as measured by distance walked in feet via a 6-minunte Walk Test
|
18-month
|
Self-reported health beliefs
Time Frame: 18-month
|
Self-reported health beliefs associated with diet, physical activity, and weight using a standardized questionnaire
|
18-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph K Kaholokula, PhD, University of Hawaii
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1.
- Sinclair KA, Zamora-Kapoor A, Townsend-Ing C, McElfish PA, Kaholokula JK. Implementation outcomes of a culturally adapted diabetes self-management education intervention for Native Hawaiians and Pacific islanders. BMC Public Health. 2020 Oct 20;20(1):1579. doi: 10.1186/s12889-020-09690-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
March 17, 2010
First Submitted That Met QC Criteria
March 24, 2010
First Posted (Estimate)
March 26, 2010
Study Record Updates
Last Update Posted (Estimate)
November 15, 2013
Last Update Submitted That Met QC Criteria
November 13, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PILI 'Ohana 5 year
- R24MD001660-04 (U.S. NIH Grant/Contract)
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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