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

NCT01042886 | Completed DMC

• 2 other identifiers: R24MD001660-03R24MD001660
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity

Keywords

Non-blind, randomized controlled trial; Pilot study

Outcome Measures

Primary Outcomes (2)

• Weight in kilograms (kg)

  Baseline, 3-month follow-up, and 9-month follow-up

• Physical functioning measured by a 6-minute walk test

  Baseline, 3-month follow-up, and 9-month follow-up

Secondary Outcomes (3)

• Blood pressure

  Baseline, 3-month follow-up, and 9-month follow-up

• Change in dietary fat intake based on self-report

  Baseline, 3-month follow-up, and 9-month follow-up

• Change in physical activity level based on self-report

  Baseline, 3-month follow-up, and 9-month follow-up

Study Arms (2)

Family plus community focused intervention

EXPERIMENTAL

Behavioral: PILI 'Ohana Lifestyle Program

Standard Behavioral Weight Loss Maintenance Intervention

ACTIVE COMPARATOR

Behavioral: Standard Behavioral Weight Loss Maintenance Program

Interventions

PILI 'Ohana Lifestyle Program BEHAVIORAL

9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.

Family plus community focused intervention

Standard Behavioral Weight Loss Maintenance Program BEHAVIORAL

9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.

Standard Behavioral Weight Loss Maintenance Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Hawaii: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Department of Native Hawaiian Health, University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Related Publications (3)

• Kaholokula JK, Townsend CK, Ige A, Sinclair Ki, Mau MK, Leake A, Palakiko DM, Yoshimura SR, Kekauoha P, Hughes C. Sociodemographic, behavioral, and biological variables related to weight loss in native Hawaiians and other Pacific Islanders. Obesity (Silver Spring). 2013 Mar;21(3):E196-203. doi: 10.1002/oby.20038.

  PMID: 23404724 DERIVED

• 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.

  PMID: 23086589 DERIVED

• Kaholokula JK, Mau MK, Efird JT, Leake A, West M, Palakiko DM, Yoshimura SR, Kekauoha BP, Rose C, Gomes H. A family and community focused lifestyle program prevents weight regain in Pacific Islanders: a pilot randomized controlled trial. Health Educ Behav. 2012 Aug;39(4):386-95. doi: 10.1177/1090198110394174. Epub 2011 May 6.

  PMID: 21551421 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph K Kaholokula, PhD

  University of Hawaii at Manoa

  STUDY DIRECTOR

• Marjorie K Mau, MD

  University of Hawaii at Manoa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 6, 2010
• Study Start: February 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 6, 2010

Record last verified: 2010-01

Locations

US (1)