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ObesityNCT01093924

Partnerships to Overcome Obesity Disparities in Hawaii: 18-month CBPR Study

A study testing PILI 'Ohana 18-month weight loss maintenance in people with Obesity, run by University of Hawaii at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
PILI 'Ohana 18-month weight loss maintenance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
4 sitesUnited States
Study dates
Oct 2009to Feb 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Hawaii Maoli

    Honolulu, Hawaii, 96807

  • Ke Ola Mamo

    Honolulu, Hawaii, 96813

  • Kula no na Po'e Hawaii

    Honolulu, Hawaii, 96816

  • Kokua Kalihi Valley

    Honolulu, Hawaii, 96819

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
PILI 'Ohana 18-month weight loss maintenance
Keywords
Behavioral weight loss maintenance intervention, Weight loss, Weight loss maintenance
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PILI 'Ohana 18-month weight loss maintenanceBehavioural

    Also called PILI 'Ohana Partnership

    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.

Study groups in NCT01093924
Study groupRoleWhat they receive
self-guided weight loss maintenanceNo intervention15-month self-guided weight loss maintenance group will receive monthly reminders to maintain their weight loss and newsletters that contain health information.
DVD groupExperimental15-month weight loss maintenance intervention deliver via DVD.
Receives: Behavioral: PILI 'Ohana 18-month weight loss maintenance
face-to-face groupExperimental15-month weight loss/weight loss maintenance intervention delivered in a group setting
Receives: Behavioral: PILI 'Ohana 18-month weight loss maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

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

    Measured: 18-months

Secondary outcomes (5)

  1. Systolic/diastolic blood pressure

    Systolic/diastolic blood pressure (mmHg) as measured by an electronic blood pressure device

    Measured: 18-months

  2. Self-reported dietary fat intake

    Self-reported dietary fat intake using an 18-item Food Frequency Questionnaire

    Measured: 18-months

  3. Self-reported physical activity

    Self-reported physical activity frequency and intensity using a 3-item brief physical activity questionnaire

    Measured: 18-months

  4. Physical functioning

    Physical functioning as measured by distance walked in feet via a 6-minunte Walk Test

    Measured: 18-month

  5. Self-reported health beliefs

    Self-reported health beliefs associated with diet, physical activity, and weight using a standardized questionnaire

    Measured: 18-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2012
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093924
Sponsor's protocol ID
PILI 'Ohana 5 year
Other IDs
R24MD001660-04
Status last verified
Nov 2013
First submitted
17 Mar 2010
Last updated
15 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33081736

  • 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.

    PubMed 23086589

Questions about this trial

What is this clinical trial studying?

A study testing PILI 'Ohana 18-month weight loss maintenance in people with Obesity, run by University of Hawaii at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: 18-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01093924, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.

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