NCT01093924

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable obesity

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

3.1 years

First QC Date

March 17, 2010

Last Update Submit

November 13, 2013

Conditions

Keywords

Behavioral weight loss maintenance interventionWeight lossWeight loss maintenance

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Amount of Weight loss in kilograms from baseline to 18 month follow-up

    18-months

Secondary Outcomes (5)

  • Systolic/diastolic blood pressure

    18-months

  • Self-reported dietary fat intake

    18-months

  • Self-reported physical activity

    18-months

  • Physical functioning

    18-month

  • Self-reported health beliefs

    18-month

Study Arms (3)

self-guided weight loss maintenance

NO INTERVENTION

15-month self-guided weight loss maintenance group will receive monthly reminders to maintain their weight loss and newsletters that contain health information.

DVD group

EXPERIMENTAL

15-month weight loss maintenance intervention deliver via DVD.

Behavioral: PILI 'Ohana 18-month weight loss maintenance

face-to-face group

EXPERIMENTAL

15-month weight loss/weight loss maintenance intervention delivered in a group setting

Behavioral: PILI 'Ohana 18-month weight loss maintenance

Interventions

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.

Also known as: PILI 'Ohana Partnership
DVD groupface-to-face group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hawaii Maoli

Honolulu, Hawaii, 96807, United States

Location

Ke Ola Mamo

Honolulu, Hawaii, 96813, United States

Location

Kula no na Po'e Hawaii

Honolulu, Hawaii, 96816, United States

Location

Kokua Kalihi Valley

Honolulu, Hawaii, 96819, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Joseph K Kaholokula, PhD

    University of Hawaii

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2010

First Posted

March 26, 2010

Study Start

October 1, 2009

Primary Completion

November 1, 2012

Study Completion

February 1, 2013

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations