PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot)

Obesity Clinical Trial

— PILI  

Official title:

Partnerships to Overcome Obesity Disparities in Hawaii

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042886
• Other study ID #: R24MD001660-03
• Secondary ID: R24MD001660
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: January 4, 2010
• Start date: February 2007
• Est. completion date: July 2008

Study information

• Verified date: January 2010
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• PILI 'Ohana Lifestyle Program
9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.
• Standard Behavioral Weight Loss Maintenance Program
9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.

Locations

Country	Name	City	State
United States	Department of Native Hawaiian Health, University of Hawaii	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in kilograms (kg)		Baseline, 3-month follow-up, and 9-month follow-up	No
Primary	Physical functioning measured by a 6-minute walk test		Baseline, 3-month follow-up, and 9-month follow-up	No
Secondary	Blood pressure		Baseline, 3-month follow-up, and 9-month follow-up	No
Secondary	Change in dietary fat intake based on self-report		Baseline, 3-month follow-up, and 9-month follow-up	No
Secondary	Change in physical activity level based on self-report		Baseline, 3-month follow-up, and 9-month follow-up	No