PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot)
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Purpose
The PILI 'Ohana CBPR partnership implemented a pilot study to determine whether a Family plus Community focused intervention will improve weight loss maintenance compared to Standard follow-up in overweight/obese Native Hawaiian (NH) and other Pacific People (PP) adults (> 18 yr. old) after receiving a standard individual-focused behavioral intervention. The primary hypothesis was that overweight/obese NH and PP adults that undergo a combined family-focused plus community-focused intervention vs. a standard follow-up after receiving a standard individual-focused behavioral intervention will have significantly higher rates of weight loss maintenance.
| Condition | Intervention |
|---|---|
|
Overweight Obesity |
Behavioral: PILI 'Ohana Lifestyle Program Behavioral: Standard Behavioral Weight Loss Maintenance Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Partnerships to Overcome Obesity Disparities in Hawaii |
- Weight in kilograms (kg) [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
- Physical functioning measured by a 6-minute walk test [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
- Change in dietary fat intake based on self-report [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
- Change in physical activity level based on self-report [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 277 |
| Study Start Date: | February 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Family plus community focused intervention |
Behavioral: PILI 'Ohana Lifestyle Program
9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.
|
| Active Comparator: Standard Behavioral Weight Loss Maintenance Intervention |
Behavioral: Standard Behavioral Weight Loss Maintenance Program
9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.
|
Detailed Description:
The long term mission of the PILI 'Ohana Program is to integrate community wisdom and expertise with scientific methods to conduct research on health disparities with a specific emphasis on obesity in NHs and PPs. Recognizing that recent advances in medicine such as the reduction of cardiovascular disease mortality and the prevention of type 2 diabetes mellitus, have not translated into benefits for all sectors of the U.S. population, especially ethnic and racial minority populations, the PILI 'Ohana Program aims to address this gap through community-academic partnerships focused on interventions to promote change in obesity-related disparities in NH and PP communities. One of the scientific goals of the PILI 'Ohana Program focused on designing and implementing research activities aimed at completing a pilot intervention study to provide the basis for a more definitive, hypothesis-driven 5-year research study in the future.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 behavioral weight loss intervention program that could potentially include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to induce weight loss of ~1-2 lbs per week;
- Able to identify at least 2-3 family, friends or co-workers that 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 (16 months);
- 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.).
Contacts and Locations| United States, Hawaii | |
| Department of Native Hawaiian Health, University of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Study Director: | Joseph K Kaholokula, PhD | University of Hawaii at Manoa |
| Principal Investigator: | Marjorie K Mau, MD | University of Hawaii at Manoa |
More Information
No publications provided by University of Hawaii
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marjorie K. Mau/Principal Investigator, Department of Native Hawaiian Health, University of Hawaii at Manoa |
| ClinicalTrials.gov Identifier: | NCT01042886 History of Changes |
| Other Study ID Numbers: | R24MD001660-03, R24MD001660 |
| Study First Received: | January 4, 2010 |
| Last Updated: | January 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Hawaii:
|
Non-blind, randomized controlled trial Pilot study |
Additional relevant MeSH terms:
|
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013